R&D Transfer Engineers lead the transition of new products from R&D to production. As a Transfer Engineer you will manage product transfers, optimize manufacturing processes, scale the manufacturing line capacity and ensure quality and cost targets are met, while working closely with cross-functional teams. This position also helps establish and implement the continuous improvement plan for new product introductions into production. This position reports directly to the VP of Technology.
R&D Transfer Engineer RESPONSIBILITIES:
- Adhere to established Plant QMS and safety policies and procedures.
- Understand and comply with all regulatory requirements such as GMP's, FDA, ISO and associated company policies and procedures.
- Create and maintain a positive work environment through continuous communication and participation in common goals, while striving to improve our products and services to meet or exceed our customer's expectations.
- Use good judgment where decisions are required in the performance of assigned tasks.
- Oversee the smooth transition of new products into manufacturing, ensuring quality, capacity and timeliness
- Develop and improve manufacturing processes to achieve cost-effective throughput and high yield.
- Create, maintain and refine a Lean toolkit that can include: 5S, Kaizen, Value Stream Mapping, mistake proofing and line balancing.
- Train production teams on new procedures and equipment.
- Manage process validations and maintain compliance with industry standards.
- Coordinate custom equipment design and installation to meet production needs
- Establish and implement continuous improvement plans for new product introductions.
- Perform other administrative duties as required.
- Maintain supplies and equipment for areas of responsibility by writing and issuing purchase orders.
R&D Transfer Engineer REQUIREMENTS:
- Previous experience in medical device development and/ or manufacturing engineering
- Understanding of FDA's 21 CFR 820 and ISO 13485
- Four-year BS degree in engineering.
- Proficiency in MS Office, SolidWorks (or CAD), lean manufacturing, and statistical analysis (Minitab, DOE).
- Strong problem-solving, leadership, and communication skills.
- Project Management experience preferred.
- Lean Six Sigma experience preferred
R&D Transfer Engineer TRAINING:
0-7 years of work experience plus a BS in engineering degree from an accredited program
Company Benefits: Medical, Dental, Vision, Short & Long term Disability, 401k with match, PTO, Sick Days, EAP
R&D Transfer Engineer REQUIREMENTS:
- Previous experience in medical device development and/ or manufacturing engineering
- Understanding of FDA's 21 CFR 820 and ISO 13485
- Four-year BS degree in engineering.
- Proficiency in MS Office, SolidWorks (or CAD), lean manufacturing, and statistical analysis (Minitab, DOE).
- Strong problem-solving, leadership, and communication skills.
- Project Management experience preferred.
- Lean Six Sigma experience preferred
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