Engineer, NPI

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. 

Job Duties:

As an integral member of the transfer team, operating under the guidance of the Project Manager, the New Product Introduction (NPI) Engineer plays a crucial role in facilitating the transition of designs into manufacturing. In close collaboration with Research and Development, Manufacturing Engineering, and Operations teams, the NPI Engineer’s key responsibilities include:

• Seamless setup of components, Bills of Material (BOMs), work instructions, and procedures, including tooling and fixtures.

• Ensure the timely transition of designs into manufacturing, actively supporting steady-state production.

• Conduct and lead Design for Excellence (DFx) projects, optimizing cycle time, material cost, and serviceability.

• Complete technical and transfer deliverables within established timelines and budget constraints.

• Provide technical guidance on all aspects of short-run beta and pilot builds, including material management, documentation, resource development, and delivery.

• Develop relationships with suppliers to resolve issues with single sources, high cost or lead time, and poor quality.

• Design parts and modify documentation utilizing SolidWorks design tools and Product Data Management (PDM) systems.

• Utilize Jira or Smartsheet in a large-scale project environment for effective communication, status updates, and milestone tracking.

• Regularly communicate technical status to customers and Gener8 stakeholders.

• Lead the creation, development, and implementation of test fixtures and equipment for complex electro-mechanical, fluidic, and optical subsystems.

• 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.

• Apply problem-solving tools and lead Root Cause Analysis (RCA) activities with cross-functional teams.

• Design and set up production lines, ensuring balance and efficiency using tools such as Value Stream Mapping (VSM) and process flow charts.

Requirements:

• Three years of experience in design, structure, and engineering analysis using SolidWorks or similar tools. 

• Two years of experience working on large-scale multimillion-dollar projects, interfacing with Scientists, Development, Quality, and Manufacturing.

• Two years of experience in direct face-to-face communication, acting as a key technical customer contact for new products being launched into production.

• Two years of experience developing fixtures across different platforms, including optics, electronics, and mechanical.

• Must have completed at least 3 Value Analysis/Value Engineering or Kaizen projects optimizing cycle time, material cost, or serviceability.

• Two years of experience employing Jira or equivalent Kanban board system on a large-scale project to manage communication and priorities.

• Two years of experience developing large-scale supply base, improving relationships and performance metrics such as cost, delivery, and quality.

• Experience must include efficiency improvements in three production lines achieved by collecting and analyzing applicable data to improve cycle time.

• Three years of experience in setting up and structuring complex instrument Bills of Material (BoMs), exceeding 1,000 line items in Arena or similar PDM.

• Technical responsibility for at least one beta or pilot unit build process of complex instruments from start to finish. 

Why Join Us?

We operate at the intersection of "cool science" and "precision engineering." You will be the guide of a company that builds the tools that save lives.

Our Culture: We value high autonomy, intellectual rigor, and a healthy dose of wit. We work hard because the software we build matters.

 Message to applicants:

The salary range posted for this position reflects the projected hiring range for new hire, full-time salaries in U.S. locations, not including benefits. For non-sales roles the hiring ranges reflect base salary only. Individual pay is determined by the candidate's hiring location and additional factors, including but not limited to skillset, experience, and relevant education, certifications, or training. Applicants may not be eligible for the full salary range based on their U.S. hiring location.

Company Benefits:

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