Senior/Staff Manufacturing Engineer

2 weeks ago

Burlingame, United States Neptune Medical Full time

The Manufacturing Engineer is responsible for supporting volume production, new product introductions, designing and validating new product SKU's (IQ-OQ-PQ), developing continuous improvements for assembly processes to achieve company initiatives for commercial success, value creation, and operational excellence.

  • Perform the implementation of design and process improvements, with innovative solutions for product enhancements, cost reduction, and scaling production
  • Author test methods and protocols, perform validation activities and similar qualifications, 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.
Required Education and Experience
  • 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 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 INCLUDE
  • 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
Work Environment and Personal Protective EquipmentThis 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

Our job titles may span more than one career level. The starting base pay for this role is between $139,000 and $170,000 per year depending on experience. The actual base pay is dependent upon many factors, such as: education, training, transferable skills, work experience, business needs, and location. The base pay range is subject to change and may be modified in the future. This role may also be eligible for equity, benefits and 401(K) with matching.

Neptune Medical provides equal employment opportunities to all applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

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