À propos
12 Months Location:
New Kensington, PA (Hybrid – 3 days onsite)
Position Overview We are seeking a
hands-on Systems Engineer with direct medical device new product development experience
who has served as a primary systems lead—not solely in a quality or support capacity. The ideal candidate will be a
broad technical systems thinker
with demonstrated ownership of system architecture, risk management, and standards compliance throughout the full product lifecycle. Candidates must have
recent medical device industry experience
and a stable employment history reflecting sustained contributions to device development programs.
Key Responsibilities Lead
end-to-end systems engineering activities
for medical device new product development programs. Develop and document
Product and Element Requirements with clear technical rationales
. Perform
standards decomposition of IEC 60601-1-11, ISO 80601-2-70, ISO 80601-2-72
, translating regulatory requirements into actionable subsystem requirements. Lead
deep-dive FMEA activities and system-level risk management (ISO 14971)
. Ensure all risk controls and mitigations are properly documented within the
Risk Management File (RMF) and Design History File (DHF)
. Develop and maintain
traceability matrices across the V-model
, ensuring bidirectional requirement flow-down and verification alignment. Define how system-level risks propagate into
software, electrical, and mechanical subsystem requirements
. Develop comprehensive
Verification & Validation (V&V) strategies, protocols, and test plans
. Serve as technical lead across R&D, manufacturing, regulatory, and quality teams to drive alignment. Mentor junior engineers in systems methodology and best practices.
Compétences linguistiques
- English
Avis aux utilisateurs
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