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.