Associate Director, Device Development — Auto-Injector

Marea Therapeutics, Inc.; South San Francisco (CA); On-site; USD 180,000 - 240,000; Full time

Job summary

Marea Therapeutics, Inc. in South San Francisco seeks an Associate Director of Device Development to lead the device component of two lead programs. You will drive design controls, verification, risk management, and regulatory content for combination products across CDMO partnerships.

The role requires hands-on leadership with external partners, cross-functional collaboration with QA, Regulatory, and Clinical teams, and on-site work in SF. Strong device development background preferred.

Qualifications

• Hands-on development of prefilled syringe and autoinjector combination products through design verification into Phase 3; BLA or NDA device experience strongly preferred.
• Experience applying design controls under 21 CFR Part 4 and 820, ISO 13485:2016, ISO 14971:2019, IEC 62366-1:2015, and ISO 11608 series.
• Track record directing external design firms, platform suppliers, test laboratories, and CMOs in an outsourced model.
• Excellent written, oral, and interpersonal communication, especially with device partners and CMOs.

Responsibilities

• Serve as Marea’s technical lead for combination product development and own design and development files for all configurations.
• Define user needs and design inputs integrating drug product attributes with device performance, ensuring traceability through verification/validation.
• Lead device risk management to ISO 14971:2019 and process risk assessments with partners.
• Plan and oversee design verification for Phase 3 readiness to ISO 11608-1:2022; develop test methods, sample sizes, acceptance criteria.
• Work with human factors specialists to plan formative and summative studies per IEC 62366-1 and FDA guidance.

Skills

Hands‑on device development

Design verification & validation

Design controls & risk management

Regulatory interactions

Vendor/CMO management

Education

B.S. in Mechanical, Biomedical, Chemical Engineering, or related field

M.S. in Mechanical, Biomedical, Chemical Engineering, or related field

Ph.D. in Mechanical, Biomedical, Chemical Engineering, or related field

Tools

Regulatory standards: ISO 13485/14971

Quality systems: 21 CFR Part 4 & 820

Job description

Marea Therapeutics, Inc. in South San Francisco seeks an Associate Director of Device Development to lead the device component of two lead programs. You will drive design controls, verification, risk management, and regulatory content for combination products across CDMO partnerships.

The role requires hands-on leadership with external partners, cross-functional collaboration with QA, Regulatory, and Clinical teams, and on-site work in SF. Strong device development background preferred.