CrawlJobs Logo

Senior Design Assurance Engineer, Software

coloplast.com Logo

Coloplast

Location Icon

Location:
United States , Minneapolis

Category Icon
Category:
IT - Software Development

Job Type Icon

Contract Type:
Employment contract

Salary Icon

Salary:

105868.00 - 158802.00 USD / Year
Save Job
Save Icon
Apply Position

Job Description:

The Interventional Urology Sr. Design Assurance Engineer, software is responsible for supporting new product development and commercial products. The position is responsible for ensuring all products are structured correctly per standard requirements, quality systems and global regulations. This role will support software project initiatives for active implantable devices and will be a key member of our product development teams.

Job Responsibility:

  • Serve as a Design Assurance partner on New Product Development (NPD) projects, participating in and leading phase, design, and test readiness reviews
  • Partner with R&D to define, review, and approve software and system design inputs, outputs, and traceability in compliance with design controls
  • Ensure applicable software, electrical, and system standards are correctly applied
  • support development and validation of software-related test methods
  • Lead and support software risk management activities, including Hazard Analysis, Software FMEA, DFMEA, and usability risk assessments
  • Support planning and execution of software verification and validation (V&V), including protocol development, test execution oversight, issue investigation, data analysis, and reporting
  • Drive continuous improvement of Design Assurance processes, SOPs, and quality deliverables to improve efficiency and compliance
  • Act as Design Assurance support for regulatory submissions, responses, and audits (internal and external)
  • Support design and process changes for commercialized products, including change impact assessment and documentation updates
  • Support design transfer from development to manufacturing, including supplier and contract manufacturer interactions
  • Provide statistical and analytical support for software test methods, validation strategies, and sample size rationale

Requirements:

  • Bachelor's Degree in Computer Science, Computer Engineering, Electrical Engineering, or related field
  • 5+ years related experience in this field – Medical device experience preferred
  • Active Implantable medical device system experience
  • Experience with regulatory standards including IEC 62304, 60601, FDA 510(k), ISO 14971, 13485
  • Knowledge of cybersecurity best practices and standards
  • Good written and verbal communication
  • Ability to consistently work, manage and lead with ethical integrity
  • Personifies Coloplast Mission, Values and Vision as well as Coloplast Leadership Promise
What we offer:
  • Comprehensive medical, dental, and vision insurance plans
  • Company sponsored wellness programs and mental health resources
  • Paid leave of absence for qualifying events
  • Generous paid parental leave for both birthing and non-birthing parents
  • Competitive 401(k) plan with company match that vest immediately
  • Financial planning services
  • Corporate discount programs for goods and services
  • Generous paid time off
  • Flexible work hours
  • Flexible work arrangement options
  • Opportunities for continuous learning and career advancement through training programs, mentorship, and tuition reimbursement
  • Recognition programs to celebrate achievements and contributions, including peer recognition, bonuses, awards, and special events
  • Supportive work environment
  • Team-building activities, volunteer opportunities, and company-sponsored events

Additional Information:

Job Posted:
May 09, 2026

Employment Type:
Fulltime
Work Type:
On-site work
Icon
Coloplast - All Job Offers
Job Link Share:
Copy Link Icon
Facebook Icon Twitter Icon LinkedIn Icon

Looking for more opportunities? Search for other job offers that match your skills and interests.

Briefcase Icon

Similar Jobs for Senior Design Assurance Engineer, Software

Senior Principal Software Quality Engineer

As a Senior Principal Software Quality Engineer at Baxter, you will play a criti...
Location
Location
United States , Raleigh
Salary
Salary:
120000.00 - 165000.00 USD / Year
https://www.baxter.com/ Logo
Baxter
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • B.S. in Engineering or other technical degree required, preferably Computer Science/Engineering or Electronics/Electrical Engineering
  • Software Quality experience is highly sought, especially in the medical device industry
  • Knowledge of AAMI 62304 standard is valuable
  • Minimum 8 years of experience in medical device or other regulated technical industry (e.g., aerospace, automotive, defense) in a design/development/quality role or in a role closely connected to design/development/quality is required
  • Proven ability to perform and influence in cross-functional team environments and utilize effective interpersonal skills
  • 2+ years of Quality experience desired
  • Product Design experience may be considered in lieu of Quality Assurance experience
  • Software development experience in a regulated industry is desirable
  • Knowledge of software development lifecycle processes and standards required
  • Understanding of software development tools and methods for medical devices and/or other regulated industries desirable
Job Responsibility
Job Responsibility
  • Responsible for all Design Assurance functions as a core team member on new product development (NPD) teams, ensuring the team complies with all portions of Design Control and related Quality System elements
  • Prepare and manage all Design Assurance required deliverables as well as support the remainder of the team in developing a quality product that meets regulatory requirements
  • Responsible for ensuring product development activities related to verification and validation are fully compliant to the quality system procedures
  • Assist in identification and mitigation of product or process-related risks
What we offer
What we offer
  • Support for Parents
  • Continuing Education/ Professional Development
  • Employee Health & 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 Software Engineer, Access Assurance

Designs, develops, troubleshoots and debugs software programs for software enhan...
Location
Location
United States , San Jose
Salary
Salary:
117500.00 - 270000.00 USD / Year
https://www.hpe.com/ Logo
Hewlett Packard Enterprise
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor's or Master's degree in Computer Science, Information Systems, or equivalent
  • Typically 10+ years experience
  • Experience designing and developing software systems design tools and languages
  • Excellent analytical and problem solving skills
  • Experience in overall architecture of software systems for products and solutions
  • Designing and integrating software systems running on multiple platform types into overall architecture
  • Evaluating and selecting forms and processes for software systems testing and methodology, including writing and execution of test plans, debugging, and testing scripts and tools
  • History of innovation with multiple patents or deployed solutions in the field of software design
  • Excellent written and verbal communication skills
  • mastery in English and local language
Job Responsibility
Job Responsibility
  • Develops organization-wide architectures and methodologies for software systems design and development across multiple platforms and organizations within the Global Business Unit
  • Identifies and evaluates new technologies, innovations, and outsourced development partner relationships for alignment with technology roadmap and business value
  • creates plans for integration and update into architecture
  • Reviews and evaluates designs and project activities for compliance with development guidelines and standards
  • provides tangible feedback to improve product quality and mitigate failure risk
  • Leverages recognized domain expertise, business acumen, and experience to influence decisions of executive business leadership, outsourced development partners, and industry standards groups
  • Provides guidance and mentoring to less- experienced staff members to set an example of software systems design and development innovation and excellence
What we offer
What we offer
  • Health & Wellbeing
  • Personal & Professional Development
  • Unconditional Inclusion
  • Fulltime
Read More
Arrow Right

Senior Software Engineer

AnaVation is seeking a highly skilled Senior Software Engineer to join our team ...
Location
Location
United States , Chantilly
Salary
Salary:
Not provided
anavationllc.com Logo
AnaVation
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor's degree in Computer Science, Software Engineering, or related field
  • Minimum of 8 years of experience in software engineering
  • Active Top Secret (TS) clearance with eligibility for Sensitive Compartmented Information (SCI)
  • Experience with SAFe Agile framework
  • Strong understanding of forensic and investigative system requirements
  • Demonstrated experience designing and implementing complex software solutions in secure government environments
  • Advanced proficiency with: One or more programming languages: Java, .NET(C#), Python
  • Complex system architecture design
  • Message brokers such as RabbitMQ, Kafka, and Redis
  • Elasticsearch, Splunk, and other data platforms
Job Responsibility
Job Responsibility
  • Design, develop, test, and manage application development projects in support of IT infrastructure
  • Integrate third-party components and introduce new custom capabilities
  • Modify existing code and recommend process improvements
  • Automate operations and maintenance tasks
  • Develop and implement technical efforts for large-scale data processing and advanced analytics
  • Participate in all aspects of the software development life cycle
  • Contribute to planning, requirements, development, testing, and quality assurance
  • Participate in technical project milestone reviews and code architecture sessions
  • Provide resource estimation and development best practices knowledge transfer
  • Participate in Program Increments (PIs) and Agile Release Train (ART) activities
What we offer
What we offer
  • Generous cost sharing for medical insurance for the employee and dependents
  • 100% company paid dental insurance for employees and dependents
  • 100% company paid long-term and short term disability insurance
  • 100% company paid vision insurance for employees and dependents
  • 401k plan with generous match and 100% immediate vesting
  • Competitive Pay
  • Generous paid leave and holiday package
  • Tuition and training reimbursement
  • Life and AD&D Insurance
  • Fulltime
Read More
Arrow Right

Senior Software Quality Engineer

Easygo leads the world in crafting top-tier entertainment experiences. Within ou...
Location
Location
Australia , Sydney
Salary
Salary:
Not provided
easygo.io Logo
Easygo Gaming
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor's degree in Computer Science, Software Engineering, or a related field, or equivalent practical experience with a strong emphasis on software quality assurance
  • 6+ years of hands-on experience in Software Quality Engineering, with a proven track record of delivering high-quality software in Agile environments
  • Proficient in designing, developing, and maintaining automated test suites and frameworks for E2E and API (e.g., using tools like Playwright, Cypress, or similar)
  • Exposure to performance testing tools such as k6 or similar, with the ability to analyse performance metrics and identify bottlenecks
  • Strong understanding of software quality principles, testing methodologies, and best practices
  • Excellent problem-solving skills with a focus on identifying and preventing defects
  • Excellent communication and collaboration skills to work effectively with cross-functional teams
  • A strong desire to learn new technologies and continuously improve testing skills
  • (Senior or higher level) Strong leadership qualities, capable of mentoring and fostering growth in others
Job Responsibility
Job Responsibility
  • Champion quality strategies within fast-paced Agile sprints, focusing on rapid feedback loops and minimising waste to accelerate product delivery
  • Design and execute rapid test cycles, including automated functional, performance, and security testing, to provide immediate feedback within CI/CD pipelines
  • Architect and optimise automated test pipelines, leveraging modern frameworks to ensure robust regression testing, and accelerate release cycles
  • Conduct strategic exploratory testing to uncover high-impact defects in rapidly evolving features, ensuring a balance between speed and thoroughness
  • Facilitate collaborative defect resolution within cross-functional teams, incorporating stakeholder feedback to drive continuous product improvement and user-centric quality
  • Proactively participate in code and design reviews, embedding quality early in the development process and fostering a culture of shared ownership
  • (Senior or higher level) Lead initiatives to drive testing innovation, adopting cutting-edge tools and methodologies to optimise testing efficiency and effectiveness in a high-velocity environment
What we offer
What we offer
  • EAP access for you and your family
  • Access to over 9,000 courses across our Learning and Development Platform
  • Paid volunteer day
  • Two full-time barista’s who will make your daily coffee, tea or fresh juice!
  • Daily catered breakfast
  • Massage Wednesdays - we get professionals to do this!
  • Team lunches and happy hour in the office from 4pm on Fridays
  • Fun office environment with pool tables, table tennis and all your favourite gaming consoles
  • Help yourself drinks fridges and snack shelves
  • Fulltime
Read More
Arrow Right

Senior Software QA/Escalation Engineer

We are looking for an experienced QA Engineer for our Bangalore location who is ...
Location
Location
India , Bengaluru
Salary
Salary:
Not provided
komprise.com Logo
Komprise, Inc.
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Quality Assurance experience to help engineering team in understanding complex customer issues and can collaborate and communicate with the engineering team effectively
  • Should be able to design and implement highly performant, scalable distributed systems
  • Ability to solve difficult problems with a simple elegant solution
  • Experience in developing management applications and performance management applications is ideal
  • Experience with NAS and object-based file systems and REST interfaces is a plus (e.g. Amazon S3, Azure, Google Cloud Service)
  • Should have a BE or higher in CS, EE, Math or related engineering or science field
  • At least 5+ years of experience in software deployment and 2+ years of experience in dealing with customer/field issues
  • Tech Stack: CIFS, NFS, Object Storage, Linux OS, Jenkins, Jira, Hypervisors, Github, Python(desirable)
Job Responsibility
Job Responsibility
  • Quality Assurance experience to help engineering team in understanding complex customer issues and can collaborate and communicate with the engineering team effectively
  • Work with a highly agile, engaged, and motivated engineering and support team
  • Identify customer issues and improve the product quality
  • Work on agile, customer focused and fast paced team with direct customer interaction
  • Responsible for reproducing customer issues in the lab, troubleshoot, analyse quickly and provide on-the-spot workaround/scripts/solutions to customers, collaborating with the Support team
  • Provide resolutions in a timely manner
  • Should be able to design and implement highly performant, scalable distributed systems
Read More
Arrow Right

Senior Software Engineer

Our senior software engineers don’t shy away from tackling the greatest of obsta...
Location
Location
Philippines , Makati City
Salary
Salary:
Not provided
lawadvisor.ventures Logo
LawAdvisor Ventures Ltd.
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • 6+ years of experience
  • Extensive professional development, documentation, and maintenance experience across the full software development lifecycle
  • Mastery in HTML, CSS, and JavaScript
  • Strong written, verbal and interpersonal skills
  • Experience working with relational databases and efficient data design and access (ORM, DAO, and SQL)
  • Experience with Git
  • The ability to steer the development of our team members and continuously bring forward new ideas
  • The ability to learn and become proficient in other programming languages in a short span of time
Job Responsibility
Job Responsibility
  • Work alongside a team of talented engineers, designers, product managers and quality assurance specialists to build and deploy exciting features and beautiful products
  • Know your fundamentals: you’re able to not just understand all the phases of the software development lifecycle but contribute to it to keep moving it forward
  • Uphold and refine standards relating to the quality, design, performance and security of code across the engineering team
  • Design and create: you write well-thought, efficient, production ready code
  • Become a leader in our product development team by partaking in solution design meetings, hiring interviews, and code reviews
  • Propose and contribute to new approaches and solutions to ensure we future-proof LawAdvisor’s infrastructure as we continue to scale globally
Read More
Arrow Right

Senior Software Development Engineer

Design and develop digital software applications and platforms to transform heal...
Location
Location
United States , Scottsdale
Salary
Salary:
151757.00 - 180000.00 USD / Year
https://www.cvshealth.com/ Logo
CVS Health
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor's degree (or foreign equivalent) in Computer Science, Computer Information Systems, Electrical Engineering, Information Technology, or a related field
  • 5 years of post-baccalaureate experience in the job offered or a related occupation
  • 5 years of experience with CI/CD, Jenkins, GIT, or DevOps
  • 5 years of experience with MySQL or NoSQL
  • 5 years of experience with XML, JSON, HTML, CSS, or JavaScript
  • 5 years of experience with Frameworks: Angular, JavaScript, React, jQuery, Ajax, Bootstrap, or Backbone
  • 5 years of experience with REST, SOAP, or Web Service APIs
  • 5 years of experience with Object-oriented JavaScript
  • 5 years of experience with Software development lifecycle (SDLC)
  • 5 years of experience with Developing backend services, performing code reviews, and collaborating with peers on software development solutions
Job Responsibility
Job Responsibility
  • Design and develop digital software applications and platforms
  • Analyze user needs and develop software solutions to meet business requirements
  • Determine feasibility of solutions design and prepare technical design documentation
  • Upgrade existing software applications and/or systems to improve functionality and features with a focus on performance, reliability, and maintainability
  • Write and review high quality code and perform unit and/or automation testing
  • Support applications, systems, and databases used to process prescriptions, claims, and related healthcare activities
  • Collaborate with cross-functional teams on applications development, technical requirements, code review, project deliverables, quality assurance, and software development best practices
  • Mentor junior team members
What we offer
What we offer
  • Bonus, commission or short-term incentive program
  • Equity award program
  • Medical benefits
  • Dental benefits
  • Vision benefits
  • 401(k) retirement savings plan
  • Employee Stock Purchase Plan
  • Term life insurance plan
  • Short-term disability benefits
  • Long-term disability benefits
  • Fulltime
Read More
Arrow Right

Senior Quality Assurance Engineer

LoadUp is a fast-growing company offering consumers a modern alternative to pick...
Location
Location
United States
Salary
Salary:
90000.00 - 100000.00 USD / Year
goloadup.com Logo
LoadUp
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • 8+ years designing and developing test automation frameworks from scratch using tools like Playwright, Selenium, Cucumber, JavaScript/TypeScript, Java, or similar
  • 4+ years hands-on software testing and writing automation code in at least one language (JavaScript, TypeScript, Java, C#, Python) and mentoring team members technically
  • 4+ years creating and executing automated tests for REST APIs, including intercepting and mocking complex HTTP calls
  • 4+ years leading complex end-to-end test automation projects
  • 4+ years using test management and defect tracking tools to drive defect strategy (priority, traceability, root cause analysis, reporting)
  • 2+ years implementing automated test suites across testing types (unit, component, API, UI, UAT, E2E)
  • Experience signing off engineering tickets through automated and manual smoke testing
  • Deep understanding of QA methodologies, defect tracking, and risk-based testing
  • Proficient with automated testing tools (RSpec, Capybara, Cypress, Playwright, Selenium) and maintaining robust test suites for frontend and backend
  • Skilled in API testing using Postman, Insomnia, or Karate
Job Responsibility
Job Responsibility
  • Ensure high-quality software at scale—test web, mobile, and APIs, collaborate with top engineers and product managers, and help deliver a transformational platform
  • Play a crucial role in scaling our platform and delivering cutting-edge capabilities to our customers across our web application, multiple mobile apps, and publicly consumed APIs
  • Collaborate with a phenomenal group of software engineers and product managers and be directly involved with the growth of our product organization to deliver and scale a transformational software product
What we offer
What we offer
  • Competitive Compensation
  • Comprehensive Health & Wellness Benefits – Medical, Dental, Vision, and Life Insurance coverage
  • Flexible Spending & Savings Options – Tailor your healthcare planning with FSA or HSA accounts
  • 401(k) with 5% Company Match
  • Employee Recognition Program
  • Monthly Lifestyle Stipends
  • Referral Rewards Program
  • Growth with Purpose
  • PTO, Sick Days & Parental Leave
  • Fulltime
Read More
Arrow Right