CrawlJobs Logo

Medical Device Validation Engineer

realign-llc.com Logo

Realign

Location Icon

Location:
United States , Danvers

Category Icon
Category:
IT - Software Development

Job Type Icon

Contract Type:
Not provided

Salary Icon

Salary:

151800.00 USD / Year
Save Job
Save Icon
Apply Position

Job Description:

Job Title: Medical Device Validation Engineer; Location: Danvers, MA (Onsite); Fulltime; Must Have Technical/Functional Skill: Prepare TMV protocols and reports and perform Validation; Apply Gage R&R (repeatability & reproducibility); Ability to select appropriate measurement tools (e.g., vernier/calipers, micrometers etc.); Roles & Responsibilities: Write clear TMV protocols and reports; Create test procedures, acceptance criteria, and validation plans; Interpret test methods, specifications, and engineering drawings; Apply Gage R&R (repeatability & reproducibility); Ability to select appropriate measurement tools (e.g., vernier/calipers, micrometers etc.); Collaborate with Engineering, Quality, Operations, and R&D; Produce clear, audit ready documentation to meet ISO and regulatory requirements for medical devices; Train operators, engineers, and quality staff on validated inspection methods and best practice

Job Responsibility:

  • Write clear TMV protocols and reports
  • Create test procedures, acceptance criteria, and validation plans
  • Interpret test methods, specifications, and engineering drawings
  • Apply Gage R&R (repeatability & reproducibility)
  • Ability to select appropriate measurement tools (e.g., vernier/calipers, micrometers etc.)
  • Collaborate with Engineering, Quality, Operations, and R&D
  • Produce clear, audit ready documentation to meet ISO and regulatory requirements for medical devices
  • Train operators, engineers, and quality staff on validated inspection methods and best practice

Requirements:

  • Prepare TMV protocols and reports and perform Validation
  • Apply Gage R&R (repeatability & reproducibility)
  • Ability to select appropriate measurement tools (e.g., vernier/calipers, micrometers etc.)

Additional Information:

Job Posted:
May 04, 2026

Employment Type:
Fulltime
Work Type:
On-site work
Icon
Realign - 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 Medical Device Validation Engineer

Director Systems Engineering, infusion systems, medical fluid management

As the Director Systems Engineering, Infusion Systems, you will lead the develop...
Location
Location
United States , Round Lake
Salary
Salary:
184000.00 - 253000.00 USD / Year
https://www.baxter.com/ Logo
Baxter
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor's or Master’s degree in Systems Engineering, Biomedical Engineering or a related field
  • Minimum of 10 years of experience in systems engineering, with a focus on medical fluid management devices (electromechanical pumps) in the medical device industry
  • Demonstrated experience leading, developing and managing engineering teams in a highly regulated environment
  • Strong technical skills, with a deep understanding of systems engineering principles and practices
  • Excellent communication and collaboration skills, with the ability to work effectively with cross-functional teams
  • Critical thinker, strong problem-solver, analytical
  • Proactive approach to project management, able to address potential risks and issues before they become critical
  • Organized, able to prioritize tasks effectively
  • Passionate about ensuring the safety and effectiveness of medical devices, and committed to delivering high-quality products that meet user needs
  • Customer focus, with a deep understanding of user needs and preferences, and a commitment to designing and developing products that meet these needs
Job Responsibility
Job Responsibility
  • Lead and develop global systems engineering teams based in Round Lake, IL, Bangalore, India, and Medina, NY
  • Create, effectively communicate and deploy the strategy for the team that aligns with the overall systems organization strategic plan
  • Own capturing system use environments, workflows, user needs and use cases across all infusion systems platforms
  • Lead systems design validation across all platforms
  • Drive creation and verification of comprehensive system requirements for new and existing infusion systems pumps, administration sets, elastomerics and accessories, ensuring they are complete, accurate, and aligned with user needs and business objectives
  • Collaborate to ensure alignment and traceability of requirements throughout the product development process
  • Implement and maintain a robust systems risk management framework to identify, analyze, and mitigate potential risks
  • Lead resource demand planning, allocation, and actuals
  • Recruit, mentor, and lead a multi-disciplinary engineering team, fostering a culture of innovation, collaboration, and continuous improvement
  • Conduct regular risk assessments and reviews ensuring compliance with medical device regulations and standards
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 starting day one
  • Basic life insurance
  • Accident insurance
  • Short-term and long-term disability insurance
  • Business travel accident insurance
  • Fulltime
Read More
Arrow Right

Director Systems Engineering

As the Director Systems Engineering, Infusion Systems, you will lead the develop...
Location
Location
United States , Round Lake
Salary
Salary:
184000.00 - 253000.00 USD / Year
https://www.baxter.com/ Logo
Baxter
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor's or Master’s degree in Systems Engineering, Biomedical Engineering or a related field
  • Minimum of 10 years of experience in systems engineering, with a focus on medical fluid management devices (electromechanical pumps) in the medical device industry
  • Demonstrated experience leading, developing and managing engineering teams in a highly regulated environment
  • Strong technical skills, with a deep understanding of systems engineering principles and practices
  • Excellent communication and collaboration skills, with the ability to work effectively with cross-functional teams
  • Critical thinker, strong problem-solver, analytical
  • Proactive approach to project management, able to address potential risks and issues before they become critical
  • Organized, able to prioritize tasks effectively
  • Passionate about ensuring the safety and effectiveness of medical devices, and committed to delivering high-quality products that meet user needs
  • Customer focus, with a deep understanding of user needs and preferences, and a commitment to designing and developing products that meet these needs
Job Responsibility
Job Responsibility
  • Lead and develop global systems engineering teams based in Round Lake, IL, Bangalore, India, and Medina, NY
  • Create, effectively communicate, and deploy the strategy for the team that aligns with the overall systems organization strategic plan
  • Own capturing system use environments, workflows, user needs and use cases across all infusion systems platforms
  • Lead systems design validation across all platforms
  • Drive creation and verification of comprehensive system requirements for new and existing infusion systems pumps, administration sets, elastomerics, and accessories, ensuring they are complete, accurate, and aligned with user needs and business objectives
  • Collaborate to ensure alignment and traceability of requirements throughout the product development process
  • Implement and maintain a robust systems risk management framework to identify, analyze, and mitigate potential risks
  • Lead resource demand planning, allocation, and actuals
  • Recruit, mentor, and lead a multi-disciplinary engineering team, fostering a culture of innovation, collaboration, and continuous improvement
  • Conduct regular risk assessments and reviews ensuring compliance with medical device regulations and standards
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 starts on day one
  • 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) with company matching
  • Flexible Spending Accounts
  • Fulltime
Read More
Arrow Right

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

Manufacturing Engineer

Eitan Medical is a fast-growing international medical device company that develo...
Location
Location
Israel , Netanya
Salary
Salary:
Not provided
eitanmedical.com Logo
Eitan Medical
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • BSc in mechanical engineering from a well-known establishment
  • At least 5 years’ experience in manufacturing engineering at a multidisciplinary company
  • Good understanding of assembling and manufacturing processes (injection molding, machining, PCB manufacturing etc.)
  • Experience in the medical device industry and with FDA and ISO 13485 medical device regulations
  • Experience with single-piece flow manufacturing processes
  • Great problem-solving and debugging capabilities
  • Full control of all Microsoft Office applications
  • SolidWorks
  • Fluent English (written and verbal)
  • Strong technical and analytical skills
Job Responsibility
Job Responsibility
  • Production process establishments and improvements
  • Resolve the company products technical issues and continuously support and improve the products’ quality
  • Lead Engineering Change Orders (ECOs) in accordance with FDA/MDR regulations, including creating production files, defining assembly processes, writing work instructions, preparing drawings
  • Conduct technical investigations and experiments, drive for root cause identification
  • Perform verification and validation activities for the production line
  • Plan, specify, implement, and maintain dedicated tools, jigs, and production equipment
  • Fulltime
Read More
Arrow Right

Electrical Engineer Student

Eitan Medical is a fast-growing international medical device company that develo...
Location
Location
Israel , Netanya
Salary
Salary:
Not provided
eitanmedical.com Logo
Eitan Medical
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • 3rd year BSc student in electrical engineering from a well-known establishment
  • Experience in the medical device industry and with FDA and ISO 13485 medical device regulations - an advantage
  • Great problem-solving and debugging capabilities
  • Availability for 24 hours a week
  • Full control of all Microsoft Office applications
  • SolidWorks
  • Fluent English (written and verbal)
  • Strong technical and analytical skills
  • excellent interpersonal relationships
  • self-motivated
Job Responsibility
Job Responsibility
  • Resolve the company products technical issues and continuously support and improve the products’ quality
  • Conduct technical investigations and experiments, drive for root cause identification as a part of the NCMR process
  • Perform verification and validation activities for the production line
  • Parttime
Read More
Arrow Right

Principal Electrical Engineer

We are seeking a highly experienced and technically driven Principal Electrical ...
Location
Location
United States , Plymouth
Salary
Salary:
Not provided
blackrockneurotech.com Logo
Blackrock Neurotech
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • B.S. in Electrical Engineering, Biomedical Engineering, or related field
  • 10+ years of experience in electrical design for active implantable medical devices (AIMDs), such as neurostimulators, pacemakers, or cochlear implants
  • Proven track record designing low-noise analog front ends, stimulation circuits, power management, and wireless telemetry (RF and inductive coupling)
  • Deep knowledge of implant power and safety considerations
  • Familiarity with closed-loop control systems and physiological signal acquisition
  • Experience operating within a quality system supporting Class III systems
  • Proficient in analog/digital mixed-signal design tools (e.g., SPICE, Altium, Cadence)
  • Strong understanding of embedded systems interfaces (SPI, I²C, UART)
  • Experience with simulation, modeling, and reliability analysis (Monte Carlo, tolerance analysis)
  • Knowledge of relevant standards: ISO 14708, IEC 60601, ISO 14971, ISO 13485, FDA Class III design controls
Job Responsibility
Job Responsibility
  • Develop circuit-level designs for ultra-low-power analog front ends, stimulation drivers, power management, and telemetry interfaces
  • Define and maintain electrical requirements, design specifications, and interface documents
  • Lead the design of production test equipment and processes
  • Perform schematic capture, circuit simulation, component selection, and PCB layout guidance for implantable and external system electronics
  • Collaborate with firmware and algorithm teams to enable closed-loop control of stimulation based on sensed physiological signals
  • Drive prototype development, bench testing, and design characterization for implantable hardware
  • Provide technical leadership to multidisciplinary design teams and mentor junior engineers
  • Champion design best practices, design for reliability (DfR), and design for manufacturability (DfM)
  • Driving verification and validation (V&V) activities, including unit, integration, and system-level testing to ensure reliability and traceability
  • Lead design verification testing (DVT) and verification planning to ensure compliance with medical device standards and safety requirements
  • Fulltime
Read More
Arrow Right

Vice President, Research & Development

The VP of Research and Development (R&D) is responsible for defining and executi...
Location
Location
United States , Alpharetta
Salary
Salary:
220000.00 - 265000.00 USD / Year
avanos.com Logo
Avanos
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor’s degree in an Engineering or Life Sciences field
  • Minimum of 15 years of experience in Engineering within the medical device industry
  • At least 7 years in a leadership or managerial role
  • Strong knowledge of medical device development processes, including design controls, risk management, and regulatory standards (FDA, ISO 13485, IEC 60601, etc.)
  • Proven track record of successfully managing cross-functional teams in the development of complex medical devices and bringing Class II or III medical devices from concept to launch
  • Strong understanding of regulatory, quality, and clinical interface in a global medical device environment
  • Proven track record of successfully managing relationships with contract designers and manufacturers in the development of complex medical devices
  • Expertise in systems engineering methodologies, including requirements management, system architecture design, integration, and testing
  • Experience developing business cases and facilitating project updates to leadership team
  • Financial and strategic acumen, being able to evaluate trade-offs between innovation, cost, and time to market
Job Responsibility
Job Responsibility
  • Defines the innovation roadmap, prioritizing opportunities based on unmet clinical needs, market potential, and technical feasibility
  • Establishes and maintains a strong R&D governance model (Product Development Process stage gates) ensuring disciplined portfolio management and timely decision-making
  • Oversees all phases of new product development, including concept, feasibility, design and development, verification and validation, design transfer, and post-market stability
  • Drives excellence in design controls, risk management, human factors, and process validations
  • Ensure alignment between R&D, Commercial, Operations, Quality, Clinical and Regulatory to facilitate launch readiness
  • Promotes the development of relationships with external designers and manufacturers that bring capabilities and capacity that support our strategy
  • Partners with universities, external research groups, suppliers, contract designers and manufacturers, and others to expand the company’s innovation network
  • Fosters a culture of innovation that balances speed, quality and compliance
  • Builds and develops a high-performing R&D organization with a clear succession, career development plans, and goals and objectives
  • Ensures that R&D activities comply with global regulatory and quality system requirements (FDA 21 CFR 820, ISO 13485, MDR, and MDSAP)
What we offer
What we offer
  • Incentive compensation program
  • Comprehensive and competitive range of benefits
  • Health care benefits
  • Retirement plans
  • Work/life benefits
  • Generous 401(k) employer match of 100% of each pretax dollar you contribute on the first 4% and 50% of the next 2% of pay contributed with immediate vesting
  • Benefits on day 1
  • Free onsite gym
  • Onsite cafeteria
  • Uncapped sales commissions
  • Fulltime
Read More
Arrow Right

Senior R&D Engineer, Catheters

We are hiring a Senior R&D Engineer to join our team and play a critical role in...
Location
Location
United States , Lake Forest
Salary
Salary:
100000.00 - 130000.00 USD / Year
m4dllc.com Logo
Manufacturing For Design
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor’s Degree in mechanical or biomedical engineering or equivalent experience
  • 3-10 years industry experience with a medical device company
  • Demonstration of excellent communication (written and oral) skills
  • Demonstration of excellent organizational skills with the ability to adapt to a rapidly changing environment
  • Prior experience with non-invasive medical devices (catheters)
  • Ability to present/teach detailed technical information, to all levels of company personnel and customers
Job Responsibility
Job Responsibility
  • Provide technical leadership for the design and development of medical devices
  • Assist in the transfer of new products from R&D to production
  • Establish processes and manufacturing documentation for new catheter products
  • Identify processes/materials to fabricate new products
  • Use CAD software (Solidworks preferred) for part and assembly design and detail drawings
  • Perform experiments to determine validity of designs
  • Provide technical leadership for development projects
  • Define product requirements
  • Design and development of tooling
  • Perform or manage design verification, equipment qualification and product and process validations
What we offer
What we offer
  • Medical Insurance, Dental Insurance, and Vision Insurance, 100% paid for employee
  • 401K Plan
  • Fulltime
Read More
Arrow Right