- Lead SLC site-specific technical engineering projects that create, design, develop, sustain, and improve production capabilities for coating, manufacturing, and assembly operations.
- Support the product transfer plans for products planned for SLC per company/site objectives.
- Collaborate with cross-functional teams on process enhancement for continuous improvement of SLC process capabilities for safety, quality, capacity, and readiness for new product transfers.
- Design and develop manufacturing processes for new and existing products, product changes and enhancements, and related tooling and fixtures modifications.
- Perform/manage validations on equipment (IQ/OQ/PQ) and processes as well as creating test protocols in collaboration with Quality Systems and preparing reports.
- Prepare document change orders (DCR) and coordinate the deployment of changes including training operation team members and improvement of manufacturing process instruction, forms, and logs.
- Improve manufacturing process instructions, product flow, assembly methods, space allocation, product quality, and safety performance for both current and new products.
- Support prototype and pilot production at SLC of new products, product changes, and enhancements in coordination with the Manufacturing and Quality Control functions.
- Coordinate with site leadership, facilities, outside service providers and other subject-matter-experts to ensure reliability and performance of process equipment to deliver product to desired specifications.
- Work with product development as assigned to ensure that products under development are optimally manufacturable and to resolve manufacturing issues for future product transfers to SLC.
- Maintain GMP systems, including pre-production quality assurance as well as post-production GMP compliance in coordination with Document Control, R&D, and Quality Assurance functions.
- Complete accurate and timely manufacturing documentation including manufacturing procedures, materials records, validations, test reports, etc.
- Support company goals and objectives, policies and procedures, Good Manufacturing Practices, and FDA regulations.
- Bachelor's Degree in Engineering, Materials, or Science required. Advanced degrees (MS/MBA) desirable.
- Minimum of 5 years of experience preferably in the regulated Medical Device or Aerospace industry.
- Knowledge of industry standard processes for assembly, specialty coating, and packaging of catheter systems.
- Proven project management experience contributing as either team leader, team member, or contributor.
- Excellent communication, cross-functional team, interpersonal, and time management skills required.
- Training/certifications in Lean/Six-Sigma, Project Management, Statistics desirable.
- Ability to work independently or in a team setting as needed.
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Description
Job Description
Job DescriptionPURPOSE OF JOB:
RESPONSIBILITIES:
PREFERRED EDUCATION:
PREFERRED EXPERIENCE:
ADDITIONAL SKILLS: