Sr Staff Device Engineer
Takeda
August 14, 2026
Remote friendly (Lexington, MA)
United States
$137,000 - $215,270 USD yearly
Operations
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, ISO13485, ISO14971).
Minimum Qualifications:
- 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.
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, ISO13485, ISO14971).
Minimum Qualifications:
- 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.