Manufacturing Engineer II
3 weeks ago
Responsibilities
- Develop, implement, and continuously improve manufacturing processes to enhance yield, reduce costs, and boost productivity.
- Represent Process Engineering in R&D and Project Team meetings, offering technical expertise in technology transfers, analytical method development, validation, and process scale-up.
- Conduct or manage process validations, including IQ/OQ, OQ, and PQ.
- Troubleshoot production line issues related to yield, quality, and throughput.
- Lead the scale-up processes from development to full-scale manufacturing.
- Support the evaluation of NCMR, CAPA, SCAR, Failure Investigation, and Deviation requests from Contract Manufacturers/Suppliers.
- Create and update manufacturing instructions, routings, bills of materials, and SOPs.
Qualifications
- Minimum of 4+ years of experience in medical device manufacturing.
- Experience with Design Transfer and Process Validations at external suppliers (CMO).
- Proficiency in writing and executing associated validations.
- Strong analytical and problem-solving skills (DOE, SPC, Six Sigma).
- Knowledge of Class II/Class III medical device manufacturing and related quality system regulations.
- Proven ability to consistently meet proposed timelines, utilizing project planning and project management skills effectively.
- Excellent oral and written communication skills; ability to communicate with both technical and non-technical audiences.
- Ability to effectively provide direction and support to external partners/suppliers.
- Preferred experience with electromechanical assemblies.
- Preferred experience with Design for Manufacturing.
- Preferred experience in fixture development.
- Preferred experience in the early stages of product development.
Education
- Bachelor's degree in Biomedical, Manufacturing, Mechanical Engineering, or a related life sciences discipline.
- Six Sigma Certification is a PLUS
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