Associate Director, Device Development — Hybrid On-Site

Marea Therapeutics, Inc.; South San Francisco (CA); On-site; USD 190,000 - 220,000; Full time

Job summary

Marea Therapeutics, Inc. in South San Francisco is seeking an Associate Director, Device Development to lead the device portion of two lead assets advancing toward Phase 3.

You will own design controls, risk management, verification, human factors, and regulatory content for IND amendments, IMPDs, BLA, and submissions while coordinating with cross-functional teams. This hands-on role requires deep experience with prefilled syringe and autoinjector devices, external partner oversight, and travel

Qualifications

• 10+ years in combination product or drug delivery device development in biotech/pharma/medical devices

Responsibilities

• Serve as technical lead for combination product development and design files across programs
• Define user needs and design inputs that integrate drug product attributes with device performance
• Lead device risk management to ISO 14971:2019, including use-related risk analysis and FMEA
• Plan design verification for Phase 3 clinical readiness per ISO 11608-1:2022 with test method development
• Collaborate with human factors to plan formative and summative studies per IEC 62366-1:2015 and FDA guidance
• Direct day-to-day work of external design partners, device suppliers, and CMOs with SOWs and reviews
• Support clinical assembly/packaging CMO selection and on-site support during builds
• Lead primary/secondary packaging development and shipping/testing strategies
• Define device portion of stability studies with Drug Product/Analytical teams
• Prepare regulatory content for IND amendments, IMPDs, BLA; interact with FDA authorities
• Coordinate quality issues, CAPAs, and investigations arising from development
• Plan scope of work for external partners and ensure on-time delivery
• Travel to partner sites in the U.S. and abroad ~10% of the time

Skills

Prefilled syringe development

Autoinjector development

External partner management

Design verification planning

Education

B.S. in Mechanical/Biomedical/Chemical Engineering or related

M.S. in Mechanical/Biomedical/Chemical Engineering or related

Ph.D. in Mechanical/Biomedical/Chemical Engineering or related

Tools

Design controls (21 CFR Part 4 & 820)

ISO 13485:2016

ISO 14971:2019

IEC 62366-1:2015

ISO 11608 series

Job description

Marea Therapeutics, Inc. in South San Francisco is seeking an Associate Director, Device Development to lead the device portion of two lead assets advancing toward Phase 3.

You will own design controls, risk management, verification, human factors, and regulatory content for IND amendments, IMPDs, BLA, and submissions while coordinating with cross-functional teams. This hands-on role requires deep experience with prefilled syringe and autoinjector devices, external partner oversight, and travel