CW Project Engineer​/TEMPORARY

Who We Are

Bio Marin is a leading, global rare disease biotechnology company focused on delivering medicines for people living with genetically defined conditions. Founded in 1997, the San Rafael, California-based company has a proven track record of innovation, with multiple commercial therapies and a strong clinical and preclinical pipeline. Using a distinctive approach to drug discovery and development, Bio Marin seeks to unleash the full potential of genetic science by pursuing category-defining medicines that have a profound impact on patients.

Our manufacturing and process development teams manage the production of our therapies for clinical trials and commercial markets. These engineers, technicians, scientists and support professionals continually provide quality assurance and ensure we meet all regulatory standards. We have manufacturing facilities in Northern California and Shanbally, Ireland. Additionally, our supply chain teams procure the goods and services needed to support manufacturing and worldwide distribution.

Hybrid Position – Tuesdays, Wednesdays and Thursdays onsite in Novato. Contract role approx 6 months.

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 to interact with technology and service providers, and contract manufacturers (CMOs) to ensure that all required activities are defined clearly and performed in a timely manner.

• 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, etc.).
• Manage/support device development including regulatory activities.
• Support all regulatory filings and related activities.
• Manage/support all stages of design control for class II/III medical devices.
• Interface with key stakeholders and outside experts/vendors to define project/product requirements to meet Bio Marin’s pipeline portfolio.
• Specify test requirements and acceptance criteria to satisfy quality and regulatory needs (e.g. Design Verification Testing, DVT).
• Lead/support risk analyses, such as hazard identification, FTA, FMEA, etc., associated with devices.
• Provide support to device component manufacturing and final product assembly with CMO.
• Support human factor engineering studies with clinical sciences group.
• As needed, facilitate product and process improvement through appropriate change controls and documentation.
• Knowledge of regulations and standards (e.g. cGMP/QSR/ICH/ISO/AAMI/ANSI/FDA/EMA).
• Working knowledge of design software packages (e.g. Solid Works) is an advantage.

This person will mainly be focused on ensuring Device Development activities are performed per regulatory guidance, industry practices and Bio Marin’s SOPs. He/she will lead, support, and coordinate between various internal functions as well as external parties to ensure that devices/combination products meet predefined requirements.

• University degree in Engineering or related scientific discipline preferred, with 8-10 years related experience in medical device/combination product development.
• Preferred MS with 8+ years or BS with 10+ years’ experience.

• Experience managing cross‑functional programs is highly desirable.
• Experience leading and coordinating human factor engineering studies.
• Experience to work in an outsourced environment and to work with contract research, development, and manufacturing organizations is highly desirable.
• Excellent written and verbal communication skills.
• Must be comfortable with leading without authority, uncertainty, and change.

• Device development, combination product development, auto injector, prefilled syringe,…