Sr. Manufacturing Engineer

2 months ago

San Jose, United States Gener8, LLC Full time
Job DescriptionJob Description

Job Description

Job Title:

Senior Manufacturing Engineer

Reporting to:

Sr. Director NPI Operations

Location:

San Jose, California

Job Site:

On-Site

Job Description Revision Date:

July 9, 2024

About us:

We know what it takes to be a key partner in the 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.

We are seeking a results-driven individual to join our growing organization as a Sr. Manufacturing Engineer in San Jose, CA.

Job Summary:

The Sr. Manufacturing Engineer is responsible for the technical success of manufacturing scientific instruments in a high-mix low-volume environment. The Sr. Manufacturing Engineer must be able to work in a dynamic, fast paced environment that collaborates with cross-functional teams and associated stakeholdersand have strong technical and communication skills to act as the technical expert responsible for ensuring smooth operation of the production line.

Job Details:

  • Driven to provide continuous improvement through innovation
  • Naturally collaborative working with Supply Chain, R&D Engineering, Production, and Quality to develop a world-class manufacturing environment
  • Determined to develop best-in-class manufacturing and test documentation
  • Experienced in improving processes yielding in profitable and reliable products
  • Committed to challenge the status quo to achieve excellence in processes and manufacturing
  • Eager to jump into problem solving with hands-on and theoretical approaches
  • Quick to formulate plans of action plans and to execute them through resolution
  • Resilient to challenging circumstances and ambiguous situations
  • Visionary at setup and leading improvement projects associated with the leading improvement projects associated with the complexities in scaling up scientific instrumentation production lines


The Sr. Manufacturing Engineer will be a leader in activities across the organization with these areas of focus:

  • Fundamental engineering and team leadership including mentoring the production team in accountability, manufacturing best practice, QMS adherence, and continuous improvement
  • Technical resource to other engineering groups, operations support teams, internal project leaders, and Gener8’s global supply base
  • Continuous process improvement planning and execution both internally and through the supply base.
  • Process verification and manufacturing documentation development through the application of theoretical and practical engineering
  • Collection of pertinent data and statistical analysis to confirm hypotheses and set direction for countermeasure implementation
  • Communication of performance and capability of the production lines in your purview to the broader organization
  • Lead in the design, documentation (including maintenance plans and calibrations), and qualification for custom and/or standard manufacturing and testing tooling, fixtures, and equipment.
  • Troubleshooting and failure analysis including corrective and preventative action plans by providing solutions using independent thinking and problem-solving skills

Knowledge, Skills and Abilities (KSAs):

Demonstrated understanding and experience executing:

  • Manufacturing equipment design and development
  • Process validation planning/execution, IQ/OQ/PQ protocols, and reports
  • Regulated industries component and manufacturing qualification processes
  • Statistical Methods for Manufacturing Process Capability and Control (SPC and Cp/Cpk)
  • Measurement System Analyses (MSA) and Gage R&R and Compatibility
  • Risk-based manufacturing documentation including pFMEAs
  • Elements of costs and reducing them
  • Design-for-manufacturing methodologies
  • The use of data to affect calibration, correlation, capability, repeatability, and reproducibility
  • Modern manufacturing processes including plastic processing, 3-D printing, rapid prototyping, metal injection, etc.

Background Experiences:

  • Minimum of 5 years of relevant work experience in regulated industries such as medical, aircraft, or automotive
  • Proficient in reading engineering drawings
  • Proficient with GD T Methodologies and tolerance analysis
  • Proficient in SolidWorks and PDM or equivalent
  • Versed and experienced in Good Manufacturing Practices (GMP).
  • Able to models, develop first principle calculations, and simulations to solve technical problems
  • This position requires you to be onsite Monday- Friday
  • Ability to travel domestically/internationally (10%) to and from San Jose, CA headquarters

    Preferred:
  • Experience in large capital equipment assembly and test
  • Experience in semi automation equipment used for aligning, assembly or metrics
  • Track record of conducting independent research bringing innovation to bear
  • Base level programming language to execute engineering scripts


  • 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; Employee discounts, Referral program.

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