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