Medical Device and Combination Products Engineer

Job Title:

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

• 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 Solid Works (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.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.