CrawlJobs Logo
Formlabs GmbH Logo Formlabs GmbH · IT - Software Development

Principal Software Engineer - Digital Systems

United States, Somerville Employment contract 140000.00 - 180000.00 USD / Year · Job Posted June 29, 2026
Apply Position
Job Link Share

Job Description

As a Principal Software Engineer at Formlabs, you will be a strategic technical leader within the Systems Department, reporting directly to the CIO. You will function as a broad enterprise architect with a builder mindset, ensuring we have a cohesive strategy for our tech stack, integrations, and built-in-house engineering principles. You will act as a consultative partner to our Digital, Financial, and Data systems teams, driving technical options and making the hard trade-off decisions on our most complex initiatives. This is a high-impact role for a technical leader who is not afraid to get hands-on with code and architecture. This role is based in our Somerville, MA office and will be a hybrid role with the expectation of at least 3 days a week in office.

Job Responsibility

  • Architecture & Strategy: Define and drive the go-forward technology strategy for our tech stack, specifically focusing on how our core platforms (Salesforce, NetSuite, Shopify) interact with custom applications and data layers
  • Solution Design: Partner consultatively with delivery teams (Financial Systems, Digital Systems, Data) to design scalable, secure, and robust solutions for major initiatives, such as our eCommerce migration and ERP optimizations
  • Hands-on Engineering: Drive options and prototypes by getting hands-on with the code
  • you will build proofs-of-concept and establish architectural patterns using Python, GCP, and containerized applications
  • Integration Governance: Own the decision-making for architecture trade-offs
  • you will hold the authority to make the final call on technical decisions to ensure long-term system stability and scalability
  • Built-in-House Principles: Establish and enforce engineering principles for our custom applications and automations, moving the department toward building efficiently and maintaining less
  • Automation Tech: Lead the discovery and architectural adoption of new toolsets, including AI supported workflows and modern integration middleware

Requirements

  • Hybrid Technical Background: You possess a unique blend of core Software Engineering experience (Python, API design) and Enterprise Systems experience (understanding how ERP, CRM, and eCommerce systems transact)
  • Integration Expertise: Proven experience designing enterprise integration patterns and middleware strategies in a complex landscape. You understand when to use an IPaaS, when to build a custom microservice, and when to use point-to-point APIs
  • Cloud Native: Deep hands-on experience with GCP (or AWS/Azure) and modern deployment practices, including Docker and Kubernetes
  • Platform Knowledge: Functional and technical familiarity with our core business stack: Salesforce, NetSuite, and Shopify
  • Data Proficiency: Strong working knowledge of SQL and data warehousing principles (experience with BigQuery is a strong plus)
  • Consultative & Decisive: You are an excellent listener who can partner with various stakeholders to find the best solution, but you are confident enough to make firm technical decisions when consensus cannot be reached

Nice to have

  • Experience with AI tooling implementation (LLMs, RAG, Agents) in an enterprise context
  • Experience with Gearset or similar DevOps tools for Salesforce
  • Familiarity with Data Engineering concepts (ETL/ELT, Airbyte)
  • Background in Security architecture and Vulnerability Management

What we offer

  • Robust equity program to build future wealth through RSUs
  • Comprehensive healthcare coverage (Medical, Dental, Vision)
  • Low cost fund options in our 401K and access to advisors
  • Generous paid Parental Leave (up to 16 weeks)
  • Tenure-based paid Sabbatical Leave (up to 6 weeks)
  • Flexible Out of Office Plan – Take time when you need it
  • Ample free on-site parking & pre-tax commuter benefits
  • Healthy on-site lunches, snacks, beverages, & treats
  • Regular sponsored professional development opportunities
  • Many opt-in culture events across our diverse community
  • unlimited 3D prints
Formlabs GmbH - All Job Offers

Looking for more opportunities?

Search for other job offers that match your skills and interests.

Suggested Tags: Frontend Developer Secretary Talent Manager Salesforce Administrator Data Analyst
Similar Jobs for

Principal Software Engineer - Digital Systems

8 matching positions

Product Owner – Sr Principal Software Systems Engineer for Digital Applications

Join our dynamic team as a Product Owner – Sr Principal Software Systems Enginee...
Location
Location
United States , Raleigh
Salary
Salary:
128000.00 - 176000.00 USD / Year
https://www.baxter.com/ Logo
Baxter
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Product Manager/Product Owner experience demonstrating strong customer focus and direct interactions with customers - preferably within regulated connected medical devices/cloud applications space
  • Experience being at customer sites regularly and having connections with hospitals/caregivers/clinical customers
  • Experience working with marketing/sales/commercial teams
  • Expertise in product backlog creation and management, requirements management, risk management, and development in an Agile environment (e.g. milestones/sprints)
  • Experience with cloud-based digital applications (e.g. SaaS/PaaS/IaaS environments with AWS/Azure or similar CSPs) is preferred
  • Experience with SaMD classified and MDDS digital/cloud applications preferred
  • Knowledge of implementing and enforcing medical device cybersecurity design paradigms is a plus
  • Exceptional oral and written communication skills
  • Strong documentation skills and experience in a regulated industry
  • A Bachelor’s degree in an engineering discipline with 10+ years of experience, or a Master’s degree with 8+ years of experience
Job Responsibility
Job Responsibility
  • Acquire and detail key customer needs/use insights through strong observation skills and communication skills
  • Collaborate with marketing, sales, and commercial departments to identify user needs that can be validated
  • Translate customer insights into product features working collaboratively with marketing
  • Work with remotely distributed teams to explain/drive product backlog and related epics to development and verification teams
  • Create and own product portfolio backlogs across multiple Digital Applications, using innovative methodologies
  • Work closely and guide individual Digital Application product owners within the portfolio to execute the product roadmap
  • Take prototypes of minimally viable product (MVP) to customers and get early feedback on digital product concepts and features
  • Work collaboratively with technical program managers assigned to product portfolios to ensure product backlog items and related epics are effectively groomed into the development cycles
  • Driving Guidelines: Implement and champion guidelines in software systems development and product lifecycles, applying Agile PDLC/SDLC and Systems Engineering methodologies in collaboration with engineering and validation groups
  • Technical Leadership: Provide guidance, mentorship, and technical leadership to a distributed R&D team, fostering a culture of innovation and excellence
What we offer
What we offer
  • Support for Parents
  • Continuing Education/ Professional Development
  • Employee Heath & Well-Being Benefits
  • Paid Time Off
  • 2 Days a Year to Volunteer
  • medical and dental coverage that start on day one
  • insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
  • Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
  • 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
  • Flexible Spending Accounts
  • Fulltime
Read More
Arrow Right

Product Owner – Sr Principal Software Systems Engineer for Digital Applications

Join our dynamic team as a Product Owner – Sr Principal Software Systems Enginee...
Location
Location
United States , Raleigh
Salary
Salary:
128000.00 - 176000.00 USD / Year
https://www.baxter.com/ Logo
Baxter
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Product Manager/Product Owner experience demonstrating strong customer focus and direct interactions with customers - preferably within regulated connected medical devices/cloud applications space
  • Experience being at customer sites regularly and having connections with hospitals/caregivers/clinical customers
  • Experience working with marketing/sales/commercial teams
  • Expertise in product backlog creation and management, requirements management, risk management, and development in an Agile environment (e.g. milestones/sprints)
  • Experience with cloud-based digital applications (e.g. SaaS/PaaS/IaaS environments with AWS/Azure or similar CSPs) is preferred
  • Experience with SaMD classified and MDDS digital/cloud applications preferred
  • Knowledge of implementing and enforcing medical device cybersecurity design paradigms is a plus.
  • Exceptional oral and written communication skills.
  • Strong documentation skills and experience in a regulated industry.
  • A Bachelor’s degree in an engineering discipline with 10+ years of experience, or a Master’s degree with 8+ years of experience.
Job Responsibility
Job Responsibility
  • Acquire and detail key customer needs/use insights through strong observation skills and communication skills
  • Collaborate with marketing, sales, and commercial departments to identify user needs that can be validated
  • Translate customer insights into product features working collaboratively with marketing
  • Work with remotely distributed teams to explain/drive product backlog and related epics to development and verification teams
  • Create and own product portfolio backlogs across multiple Digital Applications, using innovative methodologies
  • Work closely and guide individual Digital Application product owners within the portfolio to execute the product roadmap
  • Take prototypes of minimally viable product (MVP) to customers and get early feedback on digital product concepts and features
  • Work collaboratively with technical program managers assigned to product portfolios to ensure product backlog items and related epics are effectively groomed into the development cycles
  • Driving Guidelines: Implement and champion guidelines in software systems development and product lifecycles, applying Agile PDLC/SDLC and Systems Engineering methodologies in collaboration with engineering and validation groups.
  • Technical Leadership: Provide guidance, mentorship, and technical leadership to a distributed R&D team, fostering a culture of innovation and excellence.
What we offer
What we offer
  • Support for Parents
  • Continuing Education/ Professional Development
  • Employee Heath & Well-Being Benefits
  • Paid Time Off
  • 2 Days a Year to Volunteer
  • medical and dental coverage that start on day one
  • insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
  • Employee Stock Purchase Plan (ESPP)
  • 401(k) Retirement Savings Plan (RSP)
  • Flexible Spending Accounts
  • Fulltime
Read More
Arrow Right

Principal Software Systems Engineer

Join our dynamic team as a Principal Software Systems Engineer in the R&D/Softwa...
Location
Location
United States , Raleigh
Salary
Salary:
112000.00 - 154000.00 USD / Year
https://www.baxter.com/ Logo
Baxter
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor’s degree in an engineering discipline with 5+ years of experience, or a Master’s degree with 3+ years of experience
  • Proven experience with regulated products and connected systems in the medical devices/biotechnology industry preferred
  • Familiarity with electro-mechanical devices is preferred
  • Expertise in requirements management, risk management, and development in an Agile environment, including experience in creating and maintaining product backlogs
  • Knowledge of implementing and enforcing medical device cybersecurity design paradigms is a plus
  • Experience with cloud-based digital applications (e.g. SaaS/PaaS/IaaS environments with AWS/Azure or similar CSPs) is preferred
  • Exceptional oral and written communication skills
  • Strong documentation skills and experience in a regulated industry
Job Responsibility
Job Responsibility
  • Driving Best Practices: Implement and champion best practices in software systems development and product lifecycles, utilizing Agile PDLC/SDLC and Systems Engineering methodologies in collaboration with development and verification teams
  • Technical Leadership: Provide guidance, mentorship, and technical leadership to a distributed R&D team, fostering a culture of innovation and excellence
  • Complex Problem Solving: Develop innovative technical solutions to complex software system challenges, delivering high-quality results within tight deadlines
  • Architectural Contributions: Assist in establishing robust system and software architectures for digital applications, ensuring alignment with established design inputs
  • User Needs Translation: Identify and capture user needs for digital applications, translating them into functional and non-functional system requirements. Lead cross-functional teams to ensure these needs are effectively integrated into system requirements
  • Documentation and Compliance: Write, maintain, and own system-level and software-level design inputs/requirements, ensuring compliance with established Quality Management Systems (QMS) and regulatory frameworks. Work with established requirements and risk management SW tools, and develop subject matter expertise in these tools
  • Risk Management: Lead ISO 14971-based risk analysis activities, from identifying inherent hazards to implementing effective mitigation strategies
  • Verification and Validation: Collaborate with verification engineers to define test strategies for system and software verification and validation plans, utilizing requirement tracing methods
  • Hands-On Testing: Conduct ad-hoc testing of in-development and developed software systems to ensure ongoing product quality
  • Agile Execution: Enforce and support teams in executing Agile/Scrum planning, including estimating, scheduling, and completing committed tasks
What we offer
What we offer
  • Support for Parents
  • Continuing Education/ Professional Development
  • Employee Heath & Well-Being Benefits
  • Paid Time Off
  • 2 Days a Year to Volunteer
  • medical and dental coverage that start on day one
  • insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
  • Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
  • 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
  • Flexible Spending Accounts
  • Fulltime
Read More
Arrow Right

Principal Software Systems Engineer

Join our dynamic team as a Principal Software Systems Engineer in the R&D/Softwa...
Location
Location
United States , Raleigh
Salary
Salary:
112000.00 - 154000.00 USD / Year
https://www.baxter.com/ Logo
Baxter
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor’s degree in an engineering discipline with 5+ years of experience, or a Master’s degree with 3+ years of experience
  • Proven experience with regulated products and connected systems in the medical devices/biotechnology industry preferred
  • Familiarity with electro-mechanical devices is preferred
  • Expertise in requirements management, risk management, and development in an Agile environment, including experience in creating and maintaining product backlogs
  • Knowledge of implementing and enforcing medical device cybersecurity design paradigms is a plus
  • Experience with cloud-based digital applications (e.g. SaaS/PaaS/IaaS environments with AWS/Azure or similar CSPs) is preferred
  • Exceptional oral and written communication skills
  • Strong documentation skills and experience in a regulated industry
Job Responsibility
Job Responsibility
  • Driving Best Practices: Implement and champion best practices in software systems development and product lifecycles, utilizing Agile PDLC/SDLC and Systems Engineering methodologies in collaboration with development and verification teams
  • Technical Leadership: Provide guidance, mentorship, and technical leadership to a distributed R&D team, fostering a culture of innovation and excellence
  • Complex Problem Solving: Develop innovative technical solutions to complex software system challenges, delivering high-quality results within tight deadlines
  • Architectural Contributions: Assist in establishing robust system and software architectures for digital applications, ensuring alignment with established design inputs
  • User Needs Translation: Identify and capture user needs for digital applications, translating them into functional and non-functional system requirements. Lead cross-functional teams to ensure these needs are effectively integrated into system requirements
  • Documentation and Compliance: Write, maintain, and own system-level and software-level design inputs/requirements, ensuring compliance with established Quality Management Systems (QMS) and regulatory frameworks.Work with established requirements and risk management SW tools, and develop subject matter expertise in these tools
  • Risk Management: Lead ISO 14971-based risk analysis activities, from identifying inherent hazards to implementing effective mitigation strategies
  • Verification and Validation: Collaborate with verification engineers to define test strategies for system and software verification and validation plans, utilizing requirement tracing methods
  • Hands-On Testing: Conduct ad-hoc testing of in-development and developed software systems to ensure ongoing product quality
  • Agile Execution: Enforce and support teams in executing Agile/Scrum planning, including estimating, scheduling, and completing committed tasks
What we offer
What we offer
  • Support for Parents
  • Continuing Education/ Professional Development
  • Employee Heath & Well-Being Benefits
  • Paid Time Off
  • 2 Days a Year to Volunteer
  • medical and dental coverage that start on day one
  • insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
  • Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
  • 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
  • Flexible Spending Accounts
  • Fulltime
Read More
Arrow Right

Senior Principal Software Systems Engineer

Join our dynamic team as a Senior Principal Software Systems Engineer in the R&D...
Location
Location
United States , Raleigh
Salary
Salary:
128000.00 - 176000.00 USD / Year
https://www.baxter.com/ Logo
Baxter
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor’s degree in an engineering discipline with 10+ years of experience, or a Master’s degree with 8+ years of experience
  • Proven experience with regulated products and connected systems in the medical devices/biotechnology industry
  • Familiarity with electro-mechanical devices is preferred
  • Expertise in requirements management, risk management, and development in an Agile environment, including experience in creating and maintaining product backlogs
  • Knowledge of implementing and enforcing medical device cybersecurity design paradigms is a plus
  • Experience with cloud-based digital applications is preferred
  • Exceptional oral and written communication skills
  • Strong documentation skills and experience in a regulated industry
Job Responsibility
Job Responsibility
  • Driving Best Practices: Implement and champion best practices in software systems development and product lifecycles, utilizing Agile PDLC/SDLC and Systems Engineering methodologies in collaboration with development and verification teams
  • Technical Leadership: Provide guidance, mentorship, and technical leadership to a distributed R&D team, fostering a culture of innovation and excellence
  • Complex Problem Solving: Develop innovative technical solutions to complex software system challenges, delivering high-quality results within tight deadlines
  • Architectural Contributions: Assist in establishing robust system and software architectures for digital applications, ensuring alignment with established design inputs
  • User Needs Translation: Identify and capture user needs for digital applications, translating them into functional and non-functional system requirements. Lead cross-functional teams to ensure these needs are effectively integrated into system requirements
  • Documentation and Compliance: Write, maintain, and own system-level and software-level design inputs/requirements, ensuring compliance with established Quality Management Systems (QMS) and regulatory frameworks
  • Risk Management: Lead ISO 14971-based risk analysis activities, from identifying inherent hazards to implementing effective mitigation strategies
  • Verification and Validation: Collaborate with verification engineers to define test strategies for system and software verification and validation plans, utilizing requirement tracing methods
  • Hands-On Testing: Conduct ad-hoc testing of in-development and developed software systems to ensure ongoing product quality
  • Agile Execution: Enforce and support teams in executing Agile/Scrum planning, including estimating, scheduling, and completing committed tasks
What we offer
What we offer
  • Support for Parents
  • Continuing Education/ Professional Development
  • Employee Heath & Well-Being Benefits
  • Paid Time Off
  • 2 Days a Year to Volunteer
  • Medical and dental coverage that start on day one
  • Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
  • Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
  • 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
  • Flexible Spending Accounts
  • Fulltime
Read More
Arrow Right

Principal Software Systems Engineer

Join our dynamic team as a Principal Software Systems Engineer in the R&D/Softwa...
Location
Location
United States , Raleigh
Salary
Salary:
112000.00 - 154000.00 USD / Year
https://www.baxter.com/ Logo
Baxter
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor’s degree in an engineering discipline with 5+ years of experience, or a Master’s degree with 3+ years of experience
  • Proven experience with regulated products and connected systems in the medical devices/biotechnology industry preferred
  • Familiarity with electro-mechanical devices is preferred
  • Expertise in requirements management, risk management, and development in an Agile environment, including experience in creating and maintaining product backlogs
  • Knowledge of implementing and enforcing medical device cybersecurity design paradigms is a plus
  • Experience with cloud-based digital applications (e.g. SaaS/PaaS/IaaS environments with AWS/Azure or similar CSPs) is preferred
  • Exceptional oral and written communication skills
  • Strong documentation skills and experience in a regulated industry
Job Responsibility
Job Responsibility
  • Driving Best Practices: Implement and champion best practices in software systems development and product lifecycles, utilizing Agile PDLC/SDLC and Systems Engineering methodologies in collaboration with development and verification teams
  • Technical Leadership: Provide guidance, mentorship, and technical leadership to a distributed R&D team, fostering a culture of innovation and excellence
  • Complex Problem Solving: Develop innovative technical solutions to complex software system challenges, delivering high-quality results within tight deadlines
  • Architectural Contributions: Assist in establishing robust system and software architectures for digital applications, ensuring alignment with established design inputs
  • User Needs Translation: Identify and capture user needs for digital applications, translating them into functional and non-functional system requirements. Lead cross-functional teams to ensure these needs are effectively integrated into system requirements
  • Documentation and Compliance: Write, maintain, and own system-level and software-level design inputs/requirements, ensuring compliance with established Quality Management Systems (QMS) and regulatory frameworks.Work with established requirements and risk management SW tools, and develop subject matter expertise in these tools
  • Risk Management: Lead ISO 14971-based risk analysis activities, from identifying inherent hazards to implementing effective mitigation strategies
  • Verification and Validation: Collaborate with verification engineers to define test strategies for system and software verification and validation plans, utilizing requirement tracing methods
  • Hands-On Testing: Conduct ad-hoc testing of in-development and developed software systems to ensure ongoing product quality
  • Agile Execution: Enforce and support teams in executing Agile/Scrum planning, including estimating, scheduling, and completing committed tasks
What we offer
What we offer
  • Support for Parents
  • Continuing Education/ Professional Development
  • Employee Heath & Well-Being Benefits
  • Paid Time Off
  • 2 Days a Year to Volunteer
  • medical and dental coverage that start on day one
  • insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
  • Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
  • 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
  • Flexible Spending Accounts
  • Fulltime
Read More
Arrow Right

Senior Principal Software Systems Engineer

Join our dynamic team as a Senior Principal Software Systems Engineer in the R&D...
Location
Location
United States , Raleigh
Salary
Salary:
128000.00 - 176000.00 USD / Year
https://www.baxter.com/ Logo
Baxter
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor’s degree in an engineering discipline with 10+ years of experience, or a Master’s degree with 8+ years of experience
  • Proven experience with regulated products and connected systems in the medical devices/biotechnology industry
  • Familiarity with electro-mechanical devices is preferred
  • Expertise in requirements management, risk management, and development in an Agile environment, including experience in creating and maintaining product backlogs
  • Knowledge of implementing and enforcing medical device cybersecurity design paradigms is a plus
  • Experience with cloud-based digital applications is preferred
  • Exceptional oral and written communication skills
  • Strong documentation skills and experience in a regulated industry
Job Responsibility
Job Responsibility
  • Driving Best Practices: Implement and champion best practices in software systems development and product lifecycles, utilizing Agile PDLC/SDLC and Systems Engineering methodologies in collaboration with development and verification teams
  • Technical Leadership: Provide guidance, mentorship, and technical leadership to a distributed R&D team, fostering a culture of innovation and excellence
  • Complex Problem Solving: Develop innovative technical solutions to complex software system challenges, delivering high-quality results within tight deadlines
  • Architectural Contributions: Assist in establishing robust system and software architectures for digital applications, ensuring alignment with established design inputs
  • User Needs Translation: Identify and capture user needs for digital applications, translating them into functional and non-functional system requirements. Lead cross-functional teams to ensure these needs are effectively integrated into system requirements
  • Documentation and Compliance: Write, maintain, and own system-level and software-level design inputs/requirements, ensuring compliance with established Quality Management Systems (QMS) and regulatory frameworks
  • Risk Management: Lead ISO 14971-based risk analysis activities, from identifying inherent hazards to implementing effective mitigation strategies
  • Verification and Validation: Collaborate with verification engineers to define test strategies for system and software verification and validation plans, utilizing requirement tracing methods
  • Hands-On Testing: Conduct ad-hoc testing of in-development and developed software systems to ensure ongoing product quality
  • Agile Execution: Enforce and support teams in executing Agile/Scrum planning, including estimating, scheduling, and completing committed tasks
What we offer
What we offer
  • Support for Parents
  • Continuing Education/ Professional Development
  • Employee Heath & Well-Being Benefits
  • Paid Time Off
  • 2 Days a Year to Volunteer
  • medical and dental coverage that start on day one
  • insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
  • Employee Stock Purchase Plan (ESPP)
  • 401(k) Retirement Savings Plan (RSP)
  • Flexible Spending Accounts
  • Fulltime
Read More
Arrow Right

Senior Principal Software Systems Engineer

Join our dynamic team as a Senior Principal Software Systems Engineer in the R&D...
Location
Location
United States , Raleigh
Salary
Salary:
128000.00 - 176000.00 USD / Year
https://www.baxter.com/ Logo
Baxter
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor’s degree in an engineering discipline with 10+ years of experience, or a Master’s degree with 8+ years of experience
  • Proven experience with regulated products and connected systems in the medical devices/biotechnology industry
  • Familiarity with electro-mechanical devices is preferred
  • Expertise in requirements management, risk management, and development in an Agile environment, including experience in creating and maintaining product backlogs
  • Knowledge of implementing and enforcing medical device cybersecurity design paradigms is a plus
  • Experience with cloud-based digital applications is preferred
  • Exceptional oral and written communication skills
  • Strong documentation skills and experience in a regulated industry
Job Responsibility
Job Responsibility
  • Driving Best Practices: Implement and champion best practices in software systems development and product lifecycles, utilizing Agile PDLC/SDLC and Systems Engineering methodologies in collaboration with development and verification teams
  • Technical Leadership: Provide guidance, mentorship, and technical leadership to a distributed R&D team, fostering a culture of innovation and excellence
  • Complex Problem Solving: Develop innovative technical solutions to complex software system challenges, delivering high-quality results within tight deadlines
  • Architectural Contributions: Assist in establishing robust system and software architectures for digital applications, ensuring alignment with established design inputs
  • User Needs Translation: Identify and capture user needs for digital applications, translating them into functional and non-functional system requirements. Lead cross-functional teams to ensure these needs are effectively integrated into system requirements
  • Documentation and Compliance: Write, maintain, and own system-level and software-level design inputs/requirements, ensuring compliance with established Quality Management Systems (QMS) and regulatory frameworks
  • Risk Management: Lead ISO 14971-based risk analysis activities, from identifying inherent hazards to implementing effective mitigation strategies
  • Verification and Validation: Collaborate with verification engineers to define test strategies for system and software verification and validation plans, utilizing requirement tracing methods
  • Hands-On Testing: Conduct ad-hoc testing of in-development and developed software systems to ensure ongoing product quality
  • Agile Execution: Enforce and support teams in executing Agile/Scrum planning, including estimating, scheduling, and completing committed tasks
What we offer
What we offer
  • Support for Parents
  • Continuing Education/ Professional Development
  • Employee Heath & Well-Being Benefits
  • Paid Time Off
  • 2 Days a Year to Volunteer
  • Medical and dental coverage that start on day one
  • Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
  • Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
  • 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
  • Flexible Spending Accounts
  • Fulltime
Read More
Arrow Right