At Sunrise we’re working on groundbreaking, life changing medical devices. Our engineering

excellence is guided by our values centered on client success, uncompromising integrity,

constant respect for people, collaboration, innovation, and continuous learning.

The ideal candidate will work closely with cross-functional teams to develop and execute test

strategies across the product lifecycle, supporting both design verification and system validation

in compliance with FDA and international standards.

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Responsibilities:

● 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.

We’re looking for:

● 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.

Why work with us?

● A comprehensive benefits package including 100% company paid Dental, Life and Disability insurance.

● Three weeks’ vacation, unlimited sick pay plus 10 paid holidays

● Monthly lunches and “Bagel Tuesday”

● Hybrid work options

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