Principal Design Quality Engineer - SaMD

Principal Design Quality Engineer – SaMD & Innovative Medical Devices

Boston, MA (Hybrid 3 days on site)

$130,000 – $190,000 Base Salary

2 stage interview process

Lead first of a kind SaMD platforms and Class II/III devices transforming patient care worldwide. Surrounded by high growth teams building quality into complex software-hardware systems from Day 1.

You will be:

• Leading risk management (ISO 14971/IEC 62304), design controls, SW validation and system integration for FDA-cleared platforms
• Leading DQA for cross-functional teams through DV&V, usability, test method validation and post-market CAPA/NCR
• Owning quality system compliance and audit response for IEC 60601, ISO 13485, EU MDR regulated products
• Coaching R&D engineers on risk-based decision-making and failure mode analysis for complex SaMD systems

You must have:

• 10+ yrs medical device Design QE with SaMD/MEE/MES
• Proven DV&V leadership across HW/SW/firmware integration
• Experienced in regulated environments including ISO 13485:2016, QMSR (21 CFR Part 820), EU MDR, IEC 62304/60601
• Risk management expert (dFMEA/pFMEA, SW hazard analysis)
• FDA/EU MDR audit experience
• A degree in Biomedical/Electrical Engineering (or equivalent)

You will standout if you have direct SaMD experience

Local candidates required – 3 days a week onsite. No sponsorship available for this requirement.