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.
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.
- 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