Medical Device and Combination Products Engineer
Location : Novato, CA
Contractor Work Model : Hybrid (Tues, Weds, Thurs on-site)
Hours : M-F normal business hours
Compensation : $100-$103.45
Type : Contract, Potential for extension or conversion to permanent 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 company 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.
- Facilitate product and process improvement through appropriate change controls and documentation as needed.
- Maintain knowledge of regulations and standards (e.g., cGMP/QSR/ICH/ISO/AAMI/ANSI/FDA/EMA).
- Utilize design software packages such as SolidWorks (advantageous).
- University degree in Engineering or related scientific discipline preferred, with 8-10 years related experience in medical device / combination product development.
- 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 leading without authority, managing uncertainty, and adapting to change.
- Knowledge of device development, combination product development, auto injectors, prefilled syringes, needle safety devices, on-body injectors, vial and syringe development.
- Experience with design history files, risk management (DFMEA, UFMEA, PFMEA), design traceability, verification, validation, and process development.
- Ability to develop test methods and reports, and experience in design for assembly and manufacturability.
- Experience working with external device component companies, vendors, and CDMOs.
#LI- Ref: #558-Scientific
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