(CW) Project Engineer (CONTRACT/TEMPORARY)

(CW) Project Engineer (CONTRACT/TEMPORARY) Employer BioMarin Pharmaceutical Inc. Location San Rafael, California Start date Apr 13, 2026 View more categories View less categories Discipline Engineering , Process Engineer Required Education Bachelors Degree Position Type Full time Hotbed Biotech Bay , Best Places to Work Apply now Save job Click to add the job to your shortlist You need to sign in or create an account to save a job. Send job Job Details Company Job Details The Medical Device and Combination Products Engineer (Sr Engineer 2 Level 8) is responsible for 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 will represent BioMarin 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.

RESPONSIBILITIES

• Drive device and combination product development related engineering activities on critical pipeline products. This includes 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 BioMarin'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.c

GMP/QSR/ICH/ISO/AAMI/ANSI/FDA/EMA

)

• Working knowledge of design software packages e.

g. SolidWorks an advantage. SCOPE This person will mainly be focused on ensuring Device Development activities to be performed per Regulatory guidance, industry practices and BioMarin'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.

EDUCATION

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

• University degree in Engineering or related scientific discipline preferred.

Prefer MS with 8+ years or BS with 10+ years' experience.

EXPERIENCE

• Experience managing cross functional programs is highly desirable.
• Experience leading and coordinating human factor engineering studies
• Experience to work in an out-sourced 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.

Desired Skills:

• 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. Developing test methods
• Design for assembly, design for manufacturability
• Design input requirements, user requirements
• Design output specification
• Experience in working with external device component companies, vendors and CDMOs Manager is not interested in the following:
• Lab technicians
• Information technology engineers
• Quality or regulatory engineers

Note:

This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned. Equal Opportunity Employer/Veterans/Disabled An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Company At BioMarin, we translate the promise of genetic discovery into medicines that make a profound impact on the life of each patient. Since our founding in 1997, we've developed a proven track record of innovation with eight commercial therapies and a strong clinical and preclinical pipeline. Using a distinctive approach to drug discovery and development, we seek to unleash the full potential of genetic science by pursuing category-defining medicines that offer new possibilities for people living with genetically defined conditions around the world. As we have looked to expand our impact, our approach to cutting-edge science has remained the same. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science.

Company info Website https:

//www.biomarin.com/ Location San Rafael and Novato California United States Share this job Facebook Twitter LinkedIn Apply now Send job Apply now Save job Click to add the job to your shortlist You need to sign in or create an account to save a job. Get job alerts Create a job alert and receive personalized job recommendations straight to your inbox. Create alert