iO Associates ยท 3 days ago
Principal Design Quality Engineer - SaMD
Boston, MA
Full-time
Hybrid
Lead/Staff
$130K/yr - $190K/yr
10+ years expiO Associates is seeking a Principal Design Quality Engineer specializing in Software as a Medical Device (SaMD) and innovative medical devices. The role involves leading quality assurance efforts for FDA-cleared platforms and coaching cross-functional teams in risk management and compliance.
ConsultingRecruitingStaffing Agency
No H1B
Hiring Manager
George Simms
Responsibilities
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
Qualification
Required
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)
Preferred
direct SaMD experience
Company
iO Associates
iO is an industry leading IT search firm, with specialist disciplines including FinTech, development, analytics, IT security and more.
201-500 employees
Funding
Current Stage
Growth StageLeadership Team
Neil Willis-Stovold
Founder & CEO
Mark Lloyd
Director
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