Project Engineer

Job Title:

Products Engineer

Location:

Novato, CA (Hybrid)

Duration:

6+ Months

• Hybrid Position - Tues. Wed and Thurs. onsite in Novato
• Summary Description 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 Client 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 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 clinical sciences group.
• As needed, facilitate product and process improvement through appropriate change controls and documentation.
• Knowledge of regulations and standards (/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 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. 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 #TB_OTH #ZR Why TalentBurst?

At TalentBurst, we deliver more than talent, we deliver outcomes. We partner with you to move quickly and connect you to opportunities aligned with your skills and long term growth. Backed by precision, transparency, and results, we connect top talent with leading organizations through trusted partnerships. We offer competitive compensation and comprehensive benefits, including medical, dental, vision, and retirement options. TalentBurst is an equal opportunity employer committed to an inclusive and diverse workforce.