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Senior Manufacturing Engineer

1 month ago

Fremont, California, United States Think Surgical Full time
Job Summary

The Senior Manufacturing Engineer will be a key member of our multi-disciplinary team responsible for developing and manufacturing robotic devices for orthopedic surgeries. This role will involve working on new and next-generation products, improving existing product effectiveness, line extensions, manufacturing technology transfers, and general product improvements.

Key Responsibilities
  • Collaborate with R&D and manufacturing operations to ensure seamless product development and manufacturing processes.
  • Apply manufacturing and assembly process knowledge to assess product designs for manufacturability and provide technical direction to vendors.
  • Develop and execute test plans to determine process or material specifications, and resolve manufacturing problems.
  • Conceive, define, and plan projects involving new manufacturing concepts, equipment automation technology, and risk-based approaches.
  • Mentor other engineers and cross-functional stakeholders, and work with engineering teams to develop final product solutions within time and cost constraints.
  • Ensure cost-effective manufacturing processes and procedures are used, and provide input on equipment purchases to ensure technical suitability and consistency with production plans.
  • Develop new manufacturing practices to ensure manufacturing costs, technique, and quality are current with external industrial practices.
  • Review cost and quality of development and manufacturing processes, and recommend improvements in processes and techniques.
Requirements
  • Bachelor's degree in Mechanical Engineering or equivalent field.
  • Minimum 5-7 years' experience in process development, preferably in medical devices.
  • Hands-on experience in manufacturing and assembly of complex electro-mechanical devices, including assembly between metal components and injection molded components.
  • Strong history in applying Design for Manufacturability (DFM) and Design for Assembly (DFA) to perform tolerance stack-up within components and sub-assemblies.
  • Demonstrated application of Gage design and tolerancing.
  • Direct experience in a CNC machining environment with demonstrated success in process selection and troubleshooting.
  • Demonstrated experience with fixture development, equipment procurement, and troubleshooting.
  • Experience in investigating, diagnosing, and troubleshooting product complaints down to the component level.
  • Experience in assessing fabrication processes based on component design, including metal casting, forging, injection molding, and plastic machining.
  • Experience developing PFMEA, Control Plan, SOP, and PPAP generation associated with product and manufacturing transfers and launches.
  • Experience manufacturing electromechanical high-tolerance products at scale, including machined, cast forged, PCBA, and cables and plastic components.
  • Strong knowledge and background in medical device manufacturing and associated regulations like 21CFR 820 or other standards like ISO 13485.
  • Hands-on experience developing and executing IQ/OQ/PQ.
  • Experience in DOE development and execution, capability analysis, data collection, and reporting.
  • Experience with Test Method development for in-line and end-of-line testing.
  • Desire and ability to work in both an office and workshop environment, combining formal education with hands-on work in the shop.
  • Strong communication skills with experience with direct customer interface and vendor management.
  • Able to actively listen and convey understanding of the comments and questions of others.
  • Persuasiveness to influence change.
  • Strong experience with SolidWorks.
  • Proficiency in use of personal computers, Microsoft Office products (Excel, Word, and PowerPoint) or equivalent, and email skills required.
  • Ability to work independently.
  • Knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards.
Preferred Qualifications
  • Experience with PLCM software such as Propel, Project Management Software such as Confluence, and Smart-sheet.
  • Experience with medical device hardware, electrical, and software development.
  • Experience with sterile medical instrumentation and disposables, in a regulatory environment.
  • Strong knowledge of fundamental Quality and statistical tools.
Competencies
  • Drives results.
  • Optimizes work processes.
  • Defends design and process choices.
  • Holds stakeholders accountable.
  • Decisiveness in the face of constraints.
Physical Demands & Work Environment
  • Must be able to remain in a stationary position and operate office equipment for a prolonged period of time.
  • Physical activities include, but are not limited to, constant manual dexterity, moving about the work site, and/or handling objects weighing up to 20 lbs.
  • Other infrequent physical activities include, but are not limited to, positioning self to complete assigned tasks, and ascending/descending floors and/or ladders.
  • Occasionally work around moving mechanical parts.
  • Must be able to work in a schedule that commensurate with business operation, including work during weekends, holidays, and/or times outside of normal business hours.
  • Must be able to travel as business necessitates (up to 20%).