Senior Manufacturing Engineer

Senior Manufacturing Engineer

Direct Hire Full-Time Role

Salary Range : $125,000 - $140,000 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 the completion of company objectives.
• 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; define and execute process validations.
• Work with external contract manufacturers.
• Contribute to operation 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 mentor 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 disciplines of manufacturing operations (e.g., manufacturing, assembly and test, manufacturing engineering, subcontract, service) with a minimum of 3 years of experience in the Life Science or Medical Device industry
• Tooling and fixture design background is desired.
• Technical knowledge of assembly and test disposable and / or capital equipment.
• 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 is preferred.
• Controlled environment room (CER) experience is desired.
• SolidWorks, MiniTab, Zebra Printer hardware and software
• Proficient knowledge and skill in Microsoft Office Suite applications (Word, Excel, Project, PowerPoint, Visio)
• Excellent oral, written, and presentation communication skills and critical thinking skills
• Able to lead team activities and provide SME guidance to resources inside and outside operations.
• Able to work as a team member, multi-task, and be very flexible to adapt to the ever-changing work priorities and requirements of a dynamic, fast-growing company.
• Able to travel up to 15% of the time. Overnight or international travel may be required.
• Able to lift 10-15 pounds.

Desired Skills and Experience

Manufacturing Engineer, Medical Device, ERP, PLM, FDA, SolidWorks, MiniTab, Zebra Printer, Microsoft Office, Travel

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