Sr Staff Device Engineer

Scorpion Therapeutics; Lexington (MA); On-site; USD 170,000 - 210,000; Full time

Job summary

Scorpion Therapeutics in Lexington, MA seeks Sr. Staff Device Engineer for Commercial Device Engineering. You will serve as device SME for lifecycle management of on-market combination product devices, lead change controls, process validation, and DHF reviews.

You will coordinate tech transfer, support post-market surveillance, and align with MDR, ISO13485 and ISO14971, mentoring cross-functional teams and delivering robust design controls.

Qualifications

• SME in medical devices, especially drug delivery systems with technical leadership.
• Experience with design controls and quality system requirements (cGMP, combination product guidance).
• Experience with technology transfer and test method development/validation.
• Experience with post-market surveillance and MDR alignment.
• Strong manufacturing/process and packaging knowledge; drafting URS, protocols, and reports.

Responsibilities

• Serve as device SME for lifecycle management of on-market products.
• Lead change controls, manufacturing process validation, and DHF reviews.
• Support post-market surveillance and MDR input.
• Act as commercial device technical lead with cross-functional teams.
• Conduct investigations and analyze manufacturing and expansion aspects.
• Coordinate tech transfer for new drug delivery devices and resolve technical issues.
• Lead risk management activities and guide projects within budget.
• Manage design controls: specs, design verification/validation, transfer, test protocols.

Skills

Medical device SME

Cross-functional leadership

Technical leadership

Design controls

cGMP knowledge

Documentation drafting

Education

PhD in Mechanical/Electrical/Biomedical Engineering

MS in Mechanical/Electrical/Biomedical Engineering

BS in Mechanical/Electrical/Biomedical Engineering

Job description

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.