Manager, Combination Product Development

Scorpion Therapeutics; Bridgewater (MA); Hybrid; USD 124,000 - 161,000; Full time

Benefits offered by this job

Hybrid role

Remote majority

Travel 5-10%

Job summary

Scorpion Therapeutics is seeking a qualified engineer to generate process and life cycle metrics, participate in management reviews for quality metrics, and review PQC monthly metrics. The role includes risk assessment, UFMEA reviews, and updating design history files for changes.

You will lead investigations and coordinate with device manufacturers, while ensuring compliance with GxP and regulatory standards.

Qualifications

• Bachelor’s degree and 5 years in engineering/operations.
• Design Control and Risk Management experience.
• CAPA lifecycle experience including root cause investigations (RCA techniques).
• Change Control experience.
• Working knowledge of FDA Quality System Regulation (21 CFR Part 820), ISO 13485:2016, ISO 14971:2007, and EU Medical Device Regulation.
• Excellent verbal and written communication.
• Highly organized with strong attention to detail and clarity.
• Proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook).

Responsibilities

• Generate process, product, and life cycle metrics via statistical analysis.
• Participate in Management Review for combination product quality metrics.
• Review PQC monthly metrics.
• Conduct risk assessment/analysis and maintain risk management file including annual review of UFMEA.
• Perform technical assessments to update design history file for design/process changes.
• Lead complaint trend investigations (combination product and/or device).
• Lead manufacturing investigations (combination product and/or device).
• Serve as point of contact for the device manufacturer; organize regular technical meetings.
• Draft NDA amendments for major changes.
• Own device change technical assessment and change control process.
• Perform technical review of labeling, IFU, and training material changes.
• Represent in CMC meetings to assess device/combination product impact.
• Work effectively with cross-functional teams.
• Experience in GxP systems.

Skills

CAPA lifecycle

Design Control

Risk management

Change control

Regulatory knowledge

Documentation

MS Office

Communication

Education

Bachelor’s degree

Job description

What You’ll Do

• Generate process, product, and life cycle metrics via statistical analysis
• Participate in Management Review for combination product quality metrics
• Review PQC monthly metrics
• Conduct risk assessment/analysis and maintain risk management file including annual review of UFMEA
• Perform technical assessments to update design history file for design/process changes
• Lead complaint trend investigations (combination product and/or device)
• Lead manufacturing investigations (combination product and/or device)
• Serve as point of contact for the device manufacturer; organize regular technical meetings
• Draft NDA amendments for major changes
• Own device change technical assessment and change control process
• Perform technical review of labeling, IFU, and training material changes
• Represent in CMC meetings to assess device/combination product impact
• Work effectively with cross-functional teams
• Experience in GxP systems

Who You Are (Qualifications/Requirements)

• Bachelor’s degree + 5 years in engineering/operations
• Design Control and Risk Management experience
• CAPA lifecycle experience including root cause investigations (RCA techniques)
• Change Control experience
• Working knowledge of FDA Quality System Regulation (21 CFR Part 820), ISO 13485:2016, ISO 14971:2007, and EU Medical Device Regulation
• Excellent verbal and written communication
• Highly organized with strong attention to detail and clarity
• Proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook)

Nice to Have (Preferred)

• Certified Quality Engineer (or similar)
• Statistical expertise (e.g., Minitab)

Where You’ll Work / Travel / Pay

• Hybrid role (Bridgewater, NJ); remote most of the time
• Occasional global travel ~5%–10%
• $124,000.00–161,000.00 annual