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Senior Manufacturing Engineer

1 month ago

Burlingame, California, United States Neptune Medical Full time
Job Summary

The Manufacturing Engineer will be responsible for supporting volume production, new product introductions, and designing and validating new product SKU's. This role will also involve developing continuous improvements for assembly processes to achieve company initiatives for commercial success, value creation, and operational excellence.

Key Responsibilities
  • Implement design and process improvements with innovative solutions for product enhancements, cost reduction, and scaling production
  • Author test methods and protocols, perform validation activities, and generate detailed technical reports
  • Develop processing capabilities and define and author processing instructions that reduce risk and optimize production performance
  • Manage vendors for controlled/released components for the GI service providers
  • Represent Manufacturing on cross-functional teams ensuring proper DFM
  • Generate detailed component and assembly drawings as related to on-market component and fixturing changes
  • Design, document, troubleshoot, and implement new and upgraded equipment/fixturing for Production
  • Participate in supplier selection, qualification, and NCR and CAPA efforts
  • Emphasize quality and utilize a risk-driven approach to ensure compliance to risk management policies and practices and ensure Good Manufacturing Practices (GMP)
  • Contribute to the overall intellectual property position of the Company
Requirements
  • Minimum 5-7 years of related experience in the medical device industry in a manufacturing or operations role
  • Degree in one of the relevant fields of ME/BE/EE
  • Generated and managed manufacturing documentation for a commercial medical device product (MPIs, LHRs, BOM, flowcharts, etc.)
  • Capable with Onshape or SolidWorks modeling, engineering drawing generation, DFM, tolerance analysis, and tooling design
  • Possess knowledge of process validation, GMP, and state-of-the-art manufacturing processes
  • Proven track record using a variety of design tools, prototyping techniques, and evaluation methods to develop, test, and demonstrate the value of new concepts
  • Demonstrated ability to coach and train production personnel
  • Ability to exercise sound decision-making and good judgment consistent with a senior level position
  • Proficient in the Microsoft Suite, statistical analysis software is a plus
Preferred Experience and Qualifications
  • Experience in reading and interpreting engineering drawing, specifications, and statistical sampling plans
  • Experience using dimensional/visual inspection equipment, gage pins, calipers, etc
  • Comfortable working in a clean room
Work Environment and Personal Protective Equipment

This job operates in a professional office environment; many of the job's duties may be performed remotely.

This role routinely uses standard office equipment such as computers, phones, photocopiers, and scanners. Personal Protective Equipment may be required for assigned work. Work may involve lifting moderately heavy items.

While performing the duties of this job, the incumbent is regularly required to be independently mobile. Periods of prolonged sitting or standing at a computer screen.

Benefits

Stock options

401(k) program with significant matching contribution

Medical/Dental/Vision insurance fully paid for employee

15 days PTO + 6 days of sick leave per year

Company paid for lunches daily

Stocked kitchen for drinks, coffee, and snacks