Manufacturing Engineer

Job Description:

5+ years of experience & demonstrated proficiency in manufacturing, Process validation & providing ongoing technical support is preferred with evidence of continued self-development.

•  Work experience in the Medical Device industry.

Must Have Technical/Functional Skills

•  In-depth knowledge of FDA regulations, Industry standards, and guidelines such as ISO 13485 and ISO 14644.

•  Experience in control facility, warehouse and cleanroom validation

•  Knowledge of Medical Equipment manufacturing processes

•  Experience with IQ/OQ/PQ protocols

•  Experience with conducting Test method validations.

•  Ability to qualify Tooling, Gages and Fixtures

•  Knowledge in the areas of Process validation, Statistical process control, Product design & DFMA (Design for Manufacturing & Assembly), Plastic & metallic materials & processing and Applied Statistics

•  Knowledge of biocompatibility in medical device industry

•  Demonstrated ability to interpret the engineering drawings i.e., GD&T (Geometric Dimensioning &Tolerancing)

•  Understanding of Process development & design and Quality Function Deployment

•  Excellent Analytic problem solving, Broad business planning, Cross-functional integration skills.

•  Demonstrated understanding of Ergonomics and financial analysis skills preferred.

•  Excellent Interpersonal / communication skills, Organizational / planning and Project management skills preferred.

•  Understanding of Marketing & market research strategies