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Chemical/Materials Engineer
Medical Device Product Development
DE
This position is responsible for investigating, planning, and implementing improvements in medical device manufacturing processes.
- 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.
- Investigate and qualify material changes to replace obsolete materials for current products as needed to assure production continuity
- Recommend, investigate and implement manufacturing cost reduction projects
- Plan and implement specified projects to be completed including organizing and leading members of various sections, planning and scheduling, coordinating resources (personnel, materials, time, money, suppliers), preparing proper documentation, etc.
- Monitor and control production processes, identify issues and ensure they are resolved in a timely manner.
- Gather, track, and analyze production data for meetings, business plan, etc. (yields/output/efficiencies).
- Serve as the technical expert in his/her area(s) of engineering inside and outside the company
Requirements:
- BS in Chemical Engineering, Polymer Science or related field, Advanced Degree (MS / PhD) preferred
- 3 years minimum experience in medical device Process Engineering and/or Sustaining Engineering
- Experience in a manufacturing environment for designing, specifying, fabricating, assembling, and validating manufacturing equipment and processes
- Experience in catheter prototyping and/or manufacturing process
- Excellent analytical and problem solving skills
- Thorough knowledge of statistical techniques, six sigma certification highly preferred
- Thorough knowledge of FDA process validations, including development of protocols and execution of protocols.
- Successful experience leading project teams
- Thorough knowledge of equipment and tools in laboratory testing and inspection systems.
- Knowledge of GMP/FDA regulations
- Ability to create and work from engineering drawings
- Excellent communication skills both verbal and written
Candidates should submit resumes in WORD.
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