Manufacturing Process Improvement Specialist
6 days ago
At a Medical Devices company located in MN, we are seeking a highly skilled Manufacturing Quality Engineer to join our team.
Responsibilities:- Process Development and Improvement: Develop, implement, and continuously improve manufacturing processes to enhance yield, reduce costs, and improve productivity.
- Technical Expertise: Represent Process Engineering in R&D and Project Team meetings, providing technical expertise in technology transfers, analytical method development, validation, and process scale-up.
- Process Validation: Conduct or manage process validations (IQ/OQ, OQ, PQ).
- Troubleshooting: Troubleshoot production line issues related to yield, quality, and throughput.
- Process Scaling: Lead scaling up processes from development to full-scale manufacturing.
- Quality Support: Support evaluation of NCMR, CAPA, SCAR, Failure Investigation, and Deviation requests from Contract Manufacturers/Suppliers.
- Documentation: Create/update manufacturing instructions, routings, bills of materials, and SOPs.
- Experience: Minimum 4-5+ years of experience in medical device manufacturing.
- Design Transfer and Process Validations: Experience with Design Transfer and Process Validations at external suppliers (CMO).
- Analytical and Problem-Solving Skills: Strong analytical and problem-solving skills (DOE, SPC, Six Sigma).
- Regulatory Knowledge: Knowledge on Class II/Class III medical device manufacturing and related quality system regulations.
- Communication Skills: Excellent oral and written communication skills; ability to communicate with technical and non-technical audiences.
- Leadership Skills: Ability to effectively provide direction and support to external partners/suppliers.
- Preferred Qualifications: Experience with electromechanical assemblies, Design for Manufacturing, and Fixture development.
- Bachelor's Degree: Bachelors in Biomedical, Manufacturing, Mechanical Engineering, or related life sciences discipline.
- Certification: Six Sigma Certification.
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