Manufacturing Engineer
Laborie Medical Technologies Corp•Plymouth, MN
•$88,000 - $95,000•Onsite
About The Position
As a key member of the Operations team, the Manufacturing Engineer will support process development, validation, and integration of medical device manufacturing. Work will focus on process development, control, test methods, transition from bench/pilot to full scale manufacturing. Responsible for production, improving quality, reducing defects, and handling non-conforming materials and will play key role in new production line validation and implementation in a controlled work environment.
Requirements
- Bachelor’s degree in Biomedical, Mechanical or Industrial engineering, or equivalent, plus 5+ years of experience as a Manufacturing Process Engineer, preferably in Medical Devices
- Experience using statistical analysis methods for process development and control, Minitab experience preferred
- Proven experience in chemical and process engineering
- Working knowledge of process engineering software such as SolidWorks
- Ability to travel up to 25%
Nice To Haves
- Catheter/balloon catheter experience
- Injection molding experience
- Experience in Lean Manufacturing – Six Sigma certification
- Experience in ISO 13485/ISO 9000
- IQ/OQ/PQ experience
Responsibilities
- Evaluate and develop manufacturing processes, design and conduct research programs; apply knowledge of product design, fabrication, assembly, tooling and materials; conferring with equipment vendors; soliciting observations from operators.
- Responsible for manufacturing process of high-pressure catheter balloons using pleat and fold processes, testing via vacuum leak and high-pressure testing.
- Responsible for installation and qualification of all manufacturing equipment including injection molding equipment and balloon catheter pleat/fold equipment.
- Plan, document and execute process development and process validations including IQ/OQ/PQ, drafting protocol/reports, risk management (PFMEA), and statistical data analysis.
- Improve manufacturing efficiency by analyzing and planning workflow, space requirements and equipment layouts using statistical methods.
- Design and implement manufacturing fixtures and equipment.
- Support Manufacturing Supervisor by providing manufacturing decision-making information; calculating production, labor and material costs; reviews production schedules; estimates future requirements.
Benefits
- Paid time off and paid volunteer time
- Medical, Dental, Vision and Flexible Spending Account
- Health Savings Account with Company Funded Contributions
- 401k Retirement Plan with Company Match
- Parental Leave and Adoption Services
- Health and Wellness Programs and Events
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
