Senior Quality & Verification Engineer Medical Devices

Job title: Senior Quality & Verification Engineer Medical Devices
LOC - 3 days min onsite (Bedford, NH)
LOA: 4 Months, client is open to T-P at end
Start: 7/21 or sooner
Process: HR Manger will screen resume and forward to manager. If a good fit, she will ask for K s interview availabity and she will set times up.
Locals are really needed here.

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.
need protocol writing and execution skills similar to what we have been asking for
-needs to understand BLE, SW API, APP and Cloud API testing