Job Details

Are you an experienced Senior Project Engineer with a desire to excel? If so, then Talent Software Services may have the job for you! Our client is seeking an experienced Senior Project Engineer to work at their company in Novato, CA.

Position Summary: The client's Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists, and support staff build and maintain clients' cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinate the worldwide movement of our 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 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. This person will mainly be focused on ensuring Device Development activities are performed per Regulatory guidance, industry practices, and client'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.

Primary Responsibilities/Accountabilities

• 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 the client'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 the 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., SolidWorks an advantage.

Qualifications:

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 managing cross-functional programs is highly desirable.
• Experience leading and coordinating human factor engineering studies
• Experience working in an outsourced environment and working 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.

Preferred:

• 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