Sr Device Engineer

Sr. Staff Device Engineer (Commercial Device Engineering - CDE)
Responsibilities:

• Serve as device SME for combination product device lifecycle management for on-market products.
• Lead change controls, manufacturing process validation, device product complaint handling, and regular review of DHF.
• Support post-market surveillance and provide input to MDR and post-market surveillance reports.
• Act as commercial device technical lead with cross-functional teams to manage lifecycle of commercial combination products.
• Conduct technical investigations; analyze manufacturing and commercial expansion technical aspects.
• Oversee commercial device qualification; coordinate tech transfer (verification/validation) for new drug delivery devices; solve technical issues.
• Lead gap assessments/remediation and guide risk management activities; lead projects within budget.
• Manage design control activities: specifications, design verification/validation, design transfer, test protocols/reports.
• Support manufacturing expansion and process validation; ensure quality regulation system alignment (DHF, MDR, ISO
  13485, ISO
  14971).

• PhD (3+ yrs), MS (5+ yrs), or BS (8+ yrs) in Mechanical/Electrical/Biomedical Engineering or related.
• SME in medical devices, especially drug delivery systems (e.g., PFS, pen injectors, autoinjectors, needle safety devices) with technical leadership.
• Knowledge of design controls and quality system requirements; cGMP and combination product guidance.
• Strong understanding of manufacturing/process and packaging; experience drafting technical content; author URS, protocols, reports, and assessments.
• Experience with technology transfer and test method development/validation; technical leadership in cross-functional settings.
• Experience with medical device LCM change controls, complaint investigations, and post-market surveillance.