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Senior Manufacturing Engineer
2 months ago
We are seeking a highly skilled Senior Manufacturing Engineer to join our team at Medtronic, Inc. in Billerica, MA. As a key member of our engineering team, you will be responsible for providing technical guidance and support for the design, development, and optimization of products, processes, tooling, and equipment.
Key Responsibilities- Develop and implement engineering solutions to improve product quality, reduce costs, and increase efficiency.
- Collaborate with cross-functional teams to design, develop, and test new products and processes.
- Ensure compliance with FDA Quality System Regulation, 21 CFR Part 820, ISO 13485, and ISO 14971.
- Lead process improvement initiatives, including Lean Six Sigma and Value Engineering.
- Develop and maintain technical documentation, including protocols for Installation Qualification, Operational Qualification, and Performance Qualification.
- Master's degree in Mechanical, Industrial, or Biomedical Engineering or related field.
- At least two years of experience in manufacturing engineering or related occupation.
- Strong knowledge of FDA QSR, 21 CFR Part 820, ISO 13485, and ISO 14971.
- Experience with CAD tools, including SolidWorks.
- Lean Six Sigma and Value Engineering certifications.
We offer a competitive salary range of $127,900 to $146,400 per year, as well as opportunities for professional growth and development.
