Sr. Mechanical Engineer
Medical Device Product Development- Catheters
Wilmington DE

Our client is a global medical device manufacturer that develops disposable cardiovascular products. This position is located at a new R&D center near Wilmington DE.

The Mechanical Engineer will be responsible for investigating, planning, and implementing improvements in manufacturing processes that directly affect safety, quality, and productivity with the end result of producing a better quality product more efficiently, leading to improvement in yields and reduction in scrap. May at times be involved with leading projects requiring engineering team effort and/or a multi-discipline team effort. Serve as the technical expert in his/her area(s) of engineering inside and outside the company.
Travel up to 25%.

Position Requirements    
1. Troubleshoot and improve production processes, investigate and implement alternate processes to improve yield, reduce scrap, etc., using six sigma techniques. Provide technical expertise and leadership in the planning and implementation of projects to improve and/or revalidate existing manufacturing processes.
2. Investigate and qualify material changes to replace obsolete materials for current products as needed to assure production continuity
3. Recommend, investigate and implement manufacturing cost reduction projects
4. Monitor and control production processes, identify issues and ensure they are resolved in a timely manner.
5. Gather, track, and analyze production data for meetings, business plan, etc. (yields/output/efficiencies).
 

Educational Requirements    
1. BS in Mechanical Engineering or related field, Advanced Degree (MS / PhD) preferred
2. 3 years minimum experience in medical device Process Engineering and/or Sustaining Engineering
3. Experience in a manufacturing environment for designing, specifying, fabricating, assembling, and validating manufacturing equipment and processes.
4. Experience in medical disposables prototyping and/or manufacturing process
5. Excellent analytical and problem solving skills
6. Thorough knowledge of statistical techniques, six sigma certification highly preferred
7. Thorough knowledge of FDA process validations, including development of protocols and execution of protocols.
8. Successful experience leading project teams
9. Thorough knowledge of equipment and tools in laboratory testing and inspection systems.
10. Knowledge of GMP/FDA regulations
11. Ability to create and work from engineering drawings
12. Excellent communication skills both verbal and written 

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