Senior Manufacturing Engineer, Medical Device

Direct Hire Full-Time Role

Salary Range: $125,000 - $130,00 per year

Location: Hayward, CA - Onsite Role

Job Summary:

As a Senior Manufacturing Engineer, you will be responsible for manufacturing engineering, production, product support, and servicing to achieve world-class results for durable and disposable products.

Duties and Responsibilities:

• Drive manufacturing engineering and work closely with R&D and Quality to effectively transition products to manufacturing, serving as a key representative and contributor on a project development team.
• Champion New Product Introduction (NPI) activities and actively mentor and support the development team to ensure company objectives are met.
• Lead capital, durable, and disposable product transfers through to low-volume and high-volume production.
• Lead operation process definitions, including hands-on specification of MPIs, TPs, and DHRs.
• Conduct PFMEA analyses, defining and executing process validations.
• Work with external vendors and contract manufacturers.
• Contribute to operations initiatives, applying analytical and statistical methods to improve quality, reduce cost, reduce cycle time, and simplify processes.
• Review and interpret engineering drawings and technical reports (tolerance stack analysis, technical justifications, etc.).
• Provide SME guidance to Engineering for product manufacturability and design transfer.
• Provide technical expertise and mentoring to other engineers and technicians on the team.

Requirements and Qualifications:

• A bachelor's degree in engineering, manufacturing, industrial engineering, or a related discipline is required.
• 5 years of experience in one or more manufacturing disciplines (e.g., manufacturing, assembly and test, manufacturing engineering, subcontract, service) with a minimum of 3 years of experience in the Medical Device industry
• NPI experience required
• Tooling and fixture design background is desired.
• Technical knowledge of assembly and test disposable and/or capital equipment.
• Working knowledge of manufacturing engineering, ERP and PLM systems, quality assurance, and lean manufacturing processes
• Able to travel to Contract Manufacturers for process development, training, etc.
• Demonstrated knowledge of FDA regulations, ISO 9001, ISO 13485, and other national and international regulations and standards.
• Experience at start-up companies preferred.
• Controlled Environment Room (CER) experience is desired.
• SolidWorks, MiniTab, and Zebra Printer hardware and software
• Proficient and skilled in Microsoft Office Suite applications (Word, Excel, Project, PowerPoint, Visio)
• Able to lead team activities and provide SME guidance to resources inside and outside operations.
• Able to travel up to 15% of the time; overnight and international travel may be required.
• Able to lift 10-15 pounds.

Benefits:

• A variety of health insurance plans and supplemental insurance options.
• 401k retirement savings plan.
• Stock options awards and ESPP program.
• Paid time off, paid holidays, and flexible work schedule.
• Wellness program with a free onsite gym, mindfulness classes, and activities.

Desired Skills and Experience

Medical device, manufacturing, New Product Introduction, FDA, Controlled Environment Room, SolidWorks, MiniTab, Zebra Printer, Microsoft Office, travel

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