Engineer, NPI

Job Description

Job Title:

Engineer, NPI

Reporting to:

Manager, NPI

Location:

San Jose, CA

Job Site:

On-Site

Job Description Revision Date:

January 2025

About us:

We know what it takes to be a key partner in life science and medical industries. Since 2002, Gener8 has guided our customers by turning their innovative concepts into reality by providing engineering design services and manufacturing complex instruments, software, and consumables. Our customers are striving for breakthroughs in research instruments and medical diagnostic and surgical devices that will help scientists and medical professionals understand patient conditions and provide better treatment. Gener8 is a growing company with offices in San Jose and Carlsbad, CA, Wilmington, MA, Indianapolis, IN and Cartago, Costa Rica.

Summary:

The NPI Engineer will be responsible for supporting deliverables to build pre-production units in a controlled environment, to enable product transfer, to perform sustaining engineering for production devices, and to 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.

This is an onsite position at Gener8's San Jose, CA location.

Essential Duties and Responsibilities:

• Work as part of an engineering team to transition product to production, to perform iterative design updates, to identify and implement continuous process improvements, and to meet Operations' shipment goals.
• Execute internal processes following Gener8's Quality Management System (QMS), including:

Engineering Change Orders (ECO)
Non-Conformance Reports (NCR)
Return Material Authorizations (RMA)
Deviation, and Corrective and Preventive Action (CAPA) processes

• Design, build, test, and document mechanical parts and assemblies for complex instrumentation using SolidWorks and Product Data Management (PDM)
• Draft technical requirements, protocols, and reports for the verification and validation of product and fixtures
• Analyze new and existing designs to provide DFx feedback to R&D and NPI teams.
• Communicate clearly with project stakeholders and program management toidentify technical requirements, technical risk, timeline risk, and impacts of design changes.
• Utilize Jira or Smartsheet in a project environment for effective communication, status updates, and milestone tracking.
• Design and set up production lines, ensuring balance and efficiency.
• Serve as the subject matter expert and provide technical support to projects to drive development activities such as:

Fixture design
Test architecture
Process development and creation of work instructions
Hands on machining and prototyping experience
Hands on troubleshooting
Root Cause Analysis
Risk assessment
Qualification (IQ/OQ/PQ)
Verification and Validation

Supervisory Responsibility:

• This position has no direct supervisory responsibility.

Qualification Requirements:

• BS/MS degree in Mechanical Engineering or similar engineering field
• 3+ years broad new product introduction experience
• Broad technical knowledge of a variety of instrumentation fundamentals such as:

Multi-axis motion systems
Microfluidic systems
Pneumatic systems
Optical Systems

• Self-starter with ability to work independently and react quickly to changing priorities across multiple projects.
• Experience developing and structuring complex instrument bill of materials (BoMs) in Arena or similar PDM systems.
• Experience in manufacturing, test, quality, and reliability best practices under ISO 9001& ISO 13485
• Experience with failure analysis methods to identify root cause and implement corrective actions.
• Strong technical problem-solving skills, ability to critically review designs, and perform tolerance stack analysis.
• Must be fluent with SolidWorks.
• Familiarity with process analysis tools and methods such as Kaizen, Value Analysis/Value Engineering, and lean manufacturing fundamentals

• Gener8 values diversity in our workplace. Our company provides equal opportunity for employment to qualified applicants based on experience and the ability to do the available work, without regard to race, religion, color, age, sex/gender, sexual orientation, national origin, gender identity, disability, marital status, veteran status, genetic information, ancestry, or any other status protected by law. We are committed to compliance with all fair employment practices regarding citizenship and immigration status.
• We are an Everify Employer. Due to the nature of our projects, you must be a US Permanent Resident or a US Citizen for consideration.

Company Benefits:

Health, Dental and Vision insurance; 401(k) and 401(k) matching; Life insurance; STD, LTD; Flexible spending account, Health savings account; Paid time off; Paid Holidays, Bereavement and Jury Duty paid time off, Employee discounts, Referral program.