(CW) Project Engineer (CONTRACT/TEMPORARY)

BioMarin Pharmaceutical Inc.•San Rafael, CA

4d•Hybrid

About The Position

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.

Requirements

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 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.

Nice To Haves

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

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.cGMP/QSR/ICH/ISO/AAMI/ANSI/FDA/EMA)
Working knowledge of design software packages e.g. SolidWorks an advantage.