Sr. NPI Engineer

Industry: Biotech

Type: Direct Hire

Location: San Jose, CA

Pay Rate: 130-140k

A Contract Manufacturing company is seeking a Sr. NPI Engineer to join their team in Sunnyvale, CA.

The Sr. NPI Engineer will be responsible for supporting deliverables to build pre-production units in a controlled environment, enable product transfer, perform sustaining engineering for production devices, and support internal company projects. A successful candidate must be willing to take the initiative on tasks and thrive in a fast-paced dynamic environment. The candidate must be capable of collaborating with cross functional teams, have prior mechanical design experience, and prior hands-on experience troubleshooting systems.

Responsibilities:

  • Design, build, test, and document mechanical parts and assemblies for systems and subsystems of complex instrumentation
  • Design, build, test, validate, and document assembly and test fixtures
  • Analyze new and existing designs to provide DFx feedback to R&D and NPI teams
  • Work as part of an engineering team to transition product to production, perform iterative design updates, identify and implement continuous process improvements, and meet Operations’ shipment goals
  • Act as a technical lead and point of contact for the customer to translate requirements into design and process updates.
  • Serve as the subject matter expert and provide technical support of projects to help drive development activities such as
    • Test architecture and fixture design
    • Design for manufacturing, assembly, and test
    • Process development and implementation
    • Hands on machining and prototyping experience
    • Hands on troubleshooting
    • Risk assessment
    • Best practices for technical documentation (part/assembly drawings, requirements)
  • Draft protocols for verification & validation
  • Communicate clearly with project and program management to identify technical requirements, technical risk, timeline risk, and impacts of design changes
  • Provide regular updates to internal and external stakeholders

Education/Experience:

  • BS/MS degree in Mechanical Engineering
  • Familiarity with a variety of instrumentation fundamentals such as:
    • Multi-axis motion systems
    • Microfluidic systems
    • Pneumatic systems
    • Thermal transfer
    • Controls
    • High-voltage (preferred but not required)
  • Experience with ISO 13485 strongly preferred
  • Familiarity with compliance certification processes preferred but not required
  • Strong technical problem-solving skills and ability to critically review design and debug issues
  • Familiarity with process analysis tools and methods
  • Familiarity with failure analysis methods
  • Must be fluent with Solidworks

Additional Info:

For more than forty years, Richmar Associates has connected talented job seekers with Silicon Valley businesses from start-ups to Fortune 500. We specialize in the temporary and direct placement services business. Based in the Silicon Valley, Richmar offers staffing solutions that include temporary, temp-to-hire, payroll service, vendor management and direct placement services to clients in the High-Tech Industry.

Richmar is an Equal Opportunity Employer.

To apply for this job please visit app.ableteams.com.