Senior Project Engineer; Medical Device

Senior Project Engineer

Job Summary:

Talent Software Services is in search of a Senior Project Engineer for a contract position in Novato, CA. The opportunity will be for six months with a strong chance for a long‑term extension.

The client’s Technical Operations group is responsible for creating drugs for use in clinical trials and for scaling production of those drugs for the commercial market. Engineers, technicians, scientists, and support staff build and maintain cutting‑edge manufacturing processes and sites, provide quality assurance and quality control to ensure regulatory standards are met, and procure the goods and services to support manufacturing and coordinate the worldwide movement of drugs to patients.

The Medical Device and Combination Products Engineer (Sr Engineer 2, Level 8) is responsible for the development of medical device components of drug‑device combination products. Primary activity is to manage and support design control, risk management, and human factor engineering. The Engineer will lead internal device teams and represent Bio Marin in interactions with technology and service providers, and contract manufacturers (CMOs) to ensure that all required activities are defined clearly and performed in a timely manner.

The focus is on ensuring device development activities are performed per regulatory guidance, industry practices, and client SOPs, and on coordinating between internal functions and external parties to meet predefined requirements.

• Drive device and combination product development‑related engineering activities on critical pipeline products, including component and sub‑assembly design, creating design history files, and leading technical project team meetings.
• Create and own technical documentation (e.g., testing protocols, reports, SOPs, work instructions).
• Manage and support device development, including regulatory activities.
• Support all regulatory filings and related activities.
• Manage all stages of design control for class II/III medical devices.
• Interface with key stakeholders and outside experts/vendors to define product requirements for the client’s pipeline portfolio.
• Specify test requirements and acceptance criteria to satisfy quality and regulatory needs (e.g., Design Verification Testing, DVT).
• Lead or support risk analyses, such as hazard identification, FTA, FMEA, and related activities.
• Provide support to device component manufacturing and final product assembly with CMOs.
• Support human factor engineering studies with the clinical sciences group.
• Facilitate product and process improvement through appropriate change controls and documentation.
• Maintain knowledge of regulations and standards (cGMP, QSR, ICH, ISO, AAMI, ANSI, FDA, EMA).
• Have working knowledge of design software packages, e.g., Solid Works (advantage).

University degree in Engineering or related scientific discipline preferred; with 8‑10 years of experience in medical device/combination product development.

• University degree in Engineering or related scientific discipline preferred; MS with 8+ years or BS with 10+ years of experience.
• Experience managing cross‑functional programs is highly desirable.
• Experience leading and coordinating human factor engineering studies.
• Experience working in an outsourced environment with contract research, development, and manufacturing organizations is highly desirable.
• Excellent written and verbal communication skills.
• Comfortable with leading without authority, uncertainty, and change.

• Device development, combination product development, auto injector, prefilled syringe, needle safety device, on‑body injector, on‑body device, vial and syringe development.
• Design history file, risk management (DFMEA, UFMEA, PFMEA), design traceability matrix, design verification, design validation, process development.
• Design verification testing, report writing, and development of test methods.
• Design for assembly, design for manufacturability.
• Design input requirements, user requirements.
• Design output specification.
• Experience working with external device component companies, vendors, and CDMOs.