Process Development Engineer (Sunnyvale)


: $105,130.00 - $159,580.00 /year *

Employment Type

: Full-Time


: Engineering

This position will be responsible for support of on-going commercial production activities by providing technical leadership to optimize, improve and upgrade manufacturing processes. Lead process sustaining, definition and improvement, design, development and quality test activities in the making of diagnostic products or support of processes/equipment.

Duties for the Process Development Engineer:
*Troubleshoot production line issues related to yield, quality and throughput.
*Construct and execute controlled experiments to optimize processes, address yield and quality issues and drive implementation of solutions in a production environment to meet production goals.
*Analyze process test results, issue reports and make technical recommendations.
*Work cross functionally with R&D, Engineering and Quality to develop processes for new products and improve processes of existing products.
*Support supplier audits, Internal audits for compliance to ISO 13485 and FDA standards.

Skills for the Process Development Engineer:
*High level problem solving, and reasoning skills required
*Experience with product development processes and project management skills is required
*Experience in production support and/or process development is desirable
*Experience with Statistical Process Control and DOE techniques is desirable
*Good working knowledge of manufacturing equipment.
*Good written and verbal communication skills
*Ability to resolve issues quickly and recommend preventive solutions
*Strong GMP and GDP knowledge
*Knowledge of MS office suite
*Design of Experiments (e.g. JMP or equivalent) preferred
*Lean/Six Sigma experience preferred

Requirements for the Process Development Engineer:
*B.S. or M.S. required, preferred in Chemical Engineering, Biochemical Engineering.
*Or with at least 5 years relevant experience in production support or process development, design, scale-up, improvement and validation.
*5 -10 years experience in FDA and ISO 13485 regulated company, ideally IVD or Medical Device
*Working knowledge of 13485:2016
*Experience with medical device manufacturing processes qualification (IQ/OQ/PQ).
*Product manufacturing, inspection, and testing experience is desirable.
Associated topics: chemical, chemical engineering, coatings, nutrition, pha, phenolic, plastics, polymer, polymer synthesis, polypropylene * The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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