Senior Manufacturing Engineer

Recruits Lab
Published
June 24, 2022
Location
San Carlos, CA
Category
Job Type

Description

PURPOSE:

Provide leadership and support in the development, manufacture, and distribution of fully automated Sample-to-Answer NGS products consistent with the Company’s Objectives and Quality Policy. Follow and maintain quality assurance standards that adhere to ISO 13485 and similar industry regulations.

MAJOR DUTIES AND RESPONSIBILITIES:

  • Support and participate in manufacturing and design for the manufacturability of new products.
  • Lead continuous improvements and enhancements efforts that are consistent with a zero-defect level as well as low production cost. Solve complex problems at the product level.
  • Hands-on design, development, and implementation of test fixtures and tooling.
  • Evaluate, qualify, and implement design for manufacturability and cost reductions.
  • Participate in supplier selection, including product enhancements and product transfers to suppliers or contract manufacturers consistent with operations objectives.
  • Source and help manage outside suppliers and consultants as required.
  • Validate NPI purchasing specifications, drawings, manufacturing specifications, BOMs, work instructions, and assembly structures prior to release.
  • Provide engineering and technical support of Instrumentation packaging for products introduced into both the domestic and international markets.
  • Work with the Product Development, Manufacturing, and Quality Assurance functions to coordinate pilot production of new products.
  • Conduct testing and field failure analysis utilizing Six Sigma or similar tools where appropriate. Accurately generate complex written reports.
  • Support Operations on a day-to-day basis by providing technical expertise and leading troubleshooting efforts.
  • When applicable, maintain GMP systems, including pre-production quality assurance procedures, pre-clinical testing programs, and postproduction GMP compliance in coordination with Document Control, Clinical, and Quality Assurance functions. Provide support in the resolution of product complaints and/or safety issues.

Requirements

Education and/or Job Experience:

  • BS degree: Electrical Engineering, Mechanical Engineering, Bio-Medical Engineering, Physics or equivalent engineering or science discipline
  • 6+ years experience in a high-tech manufacturing environment
  • 3 years of relevant experience in the medical device industry is required.
  • Experience with Solidworks to create new parts, assemblies, and manufacturing drawings.
  • Broad experience supporting many of the following commodities or supplier types: computing, electronics, machined parts, sheet metal, cables, PCAs, plastics, power systems, product packaging, hardware, and labeling.
  • Established project management experience, including the use of PM tools for planning, tracking, and reporting.
  • Must have a strong background in the creation of engineering drawings, product structure, Bills of Materials, and operational procedures
  • Experience developing manufacturing processes, writing procedures, and training assembly personnel.
  • Must have extensive experience writing and reviewing Engineering Change Orders
  • Ability to perform word processing and create spreadsheets, and reports, and working knowledge of statistical techniques.
  • The ability to assess and resolve multiple high visibility problems in a timely manner.
  • The ability to successfully interact with executive management.
  • Ability to be effective with minimal direction.
  • Strong cGMP familiarity with 21 CFR part 820, medical industry experience, ROHS, EMC & Safety standards.
  • Willingness to travel.

Benefits

  • Full medical, dental, and vision insurance
  • Onsite organic snacks
  • Lunch onsite 5 days a week
  • Unlimited Flexible Time Off
  • Life Insurance (Basic, Voluntary & AD&D)
  • Short Term & Long Term Disability
  • Stock Option Plans

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