Senior Manufacturing Engineer

2 weeks ago

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

We are seeking a highly skilled Senior/Staff Manufacturing Engineer to join our team at Neptune Medical. This role will be responsible for supporting volume production, new product introductions, and designing and validating new product SKU's.

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.
  • Prototype fixtures using 3-D printers, lathe, drill press, band saw, etc.
  • 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.
  • Support company goals and objectives, policies, and procedures that comply with FDA Quality System Regulations (QSR), ISO 13485, and any other applicable domestic governing bodies.
  • Actively work to promote team building and morale within the GI department.
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.
  • Languages: Full professional proficiency in English is a minimum requirement.
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.
  • Ability to work well under pressure and to meet multiple and occasional competing deadlines while maintaining a cooperative working relationship with other people.
  • Ability to work in a highly detailed environment where mental focus and accuracy of work output is essential.
  • Good organizational and oral and written communication skills, including ability to represent the Company to both internal and external audiences.
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 lunches daily.
  • Stocked kitchen for drinks, coffee, and snacks.
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.

Physical Demands:

  • 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.

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