Contract position: Leading medical device company is seeking a Sr. Manufacturing Engineer for a long term opportunity. This position can be located in Marlborough, MA or Danbury, CT (or possibly remotely) and requires extensive travel around the US and Costa Rica. Qualified candidates will have a Bachelor's Degree in Mechanical Engineering or similar and 7+ years of experience with manufacturing engineering of medical devices with plastic injection molding. Responsibilities will include process validation and design remediation/improvements of existing products. Additional responsibilities and requirements below. Responsibilities for the Senior Manufacturing Engineer
Requirements for the Senior Manufacturing Engineer
- Create validation plans of process equipment including IQ OQ/PQ.
- Work with contract manufacturers/suppliers to improve on existing manufacturing processes
- Process improvement and troubleshooting exercises.
- Practice LEAN techniques and participate in Kaizens
- Bachelor's degree in Mechanical, Industrial or Electrical Engineering required
- 7+ years of manufacturing engineering experience with medical devices
- Plastics injection molding experience required (mold validation and molding process)
- Experience handling design remediation and design and process improvements required.
- Must be willing to travel (up to 70%)
- Experience in process validation for both capital equipment and disposable devices
- Proficient in root cause investigation and problem solving
- Hands-on IQ/OQ/PQ experience- Should have experience authoring reports and providing a scientific and statistically sound approach
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.