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.
Other duties as assigned; as emerging growth company, it may be required from time to time to assist in other areas other than the area of specialty.
Skills:
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 statistics, 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 knowledge of statistical analysis
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:
5 -10 years’ experience working in FDA and ISO 13485 regulated company
Working knowledge of 13485:2016
5 - 10 years of experience in biotech / IVD / Medical Device
Experience with medical device manufacturing processes qualification (IQ/OQ/PQ).
Product manufacturing, inspection, and testing experience is desirable.
Education:
B.S. or M.S. required, preferred in Chemical Engineering, Biochemical Engineering, or with at least 6 years relevant experience in production support or process development, design, scale-up, improvement and validation.