Senior Validation Engineer

Sunrise Labs, Inc.; Bedford (NH); On-site; USD 90,000 - 120,000; Full time

Job summary

A leading company in medical device development is seeking a Senior Validation Engineer to develop and implement validation strategies for complex medical devices. The role involves ensuring compliance with regulatory standards and collaborating with cross-functional teams to verify and validate product designs. Ideal candidates will have a Bachelor's degree and extensive experience in the field, along with strong analytical and communication skills.

Benefits

Medical insurance

Disability insurance

401(k)

Qualifications

• 5-10 years of experience in medical device development.
• Familiarity with Class II or Class III medical device requirements.
• Knowledge of ISO 13485 and IEC 62304.

Responsibilities

• Develop and implement V&V strategies for medical devices.
• Conduct design verification testing and system integration testing.
• Maintain Design History File and ensure regulatory compliance.

Skills

Analytical skills

Decision-making

Communication

Detail-oriented

Education

Bachelor’s degree in Engineering, Computer Science, or related field

Tools

LabVIEW

TestStand

Python

MATLAB

DOORS

Jama

Jira

Job description

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• Develop and implement V&V strategies, plans, protocols, and test reports for complex medical devices involving software-controlled hardware.
• Ensure requirements-based testing, maintaining rigorous traceability from user needs through to verification evidence.
• Conduct design verification testing (DVT), system integration testing, and design validation in support of regulatory submissions (510(k), PMA).
• Collaborate with systems, software, hardware, and quality teams to ensure that risk mitigations (per ISO 14971) are verified and validated appropriately.
• Utilize tools such as LabVIEW, TestStand, Python, MATLAB, and custom test rigs to develop automated and manual tests.
• Participate in hazard analysis, FMEAs, and fault injection testing to support robust product design.
• Maintain and audit Design History File (DHF) and ensure test documentation meets standards such as FDA 21 CFR Part 820, ISO 13485, and IEC 62304.
• Support internal and external audits, including FDA inspections and notified body reviews.
• Bachelor’s degree in Engineering, Computer Science, or a related technical discipline.
• 5-10 years of experience in medical device development, specifically in design verification and validation.
• Familiarity with Class II or Class III medical device requirements and documentation best practices.
• Knowledge of ISO 13485, and global quality assurance requirements for medical devices, including IEC 60601-1
• Solid understanding of IEC 62304 Medical Software Development Process
• Familiarity with Risk Management standards ISO 14971
• Excellent analytical and decision-making skills, as well as strong written and verbal communication
• Ability to speak effectively before groups of clients or employees.
• Proficient in test automation, requirements tools (e.g., DOORS, Jama), and defect tracking (e.g., Jira).
• Detail-oriented and capable of maintaining meticulous records for regulatory compliance.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Engineering, Design, and Science

• Industries

  Engineering Services and Medical Equipment Manufacturing

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Inferred from the description for this job

Medical insurance

Disability insurance

401(k)

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