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Manufacturing Engineer
Katalyst Healthcares & Life Sciences · Minnetonka, MN5d agoverified 8 h ago
BS-level Process Engineering roles on Crosslinked list a median of $112k (561 that show pay). This posting does not list pay.
Develop and validate manufacturing processes for high-pressure catheter balloons, including injection molding and pleat/fold equipment.
Process Engineering roles, by email
Apply Worth knowing
Why it is interesting. Hands-on with injection molding and pleat/fold equipment for critical medical device balloons.
Might not be for you. Heavy focus on process validation and documentation, less open-ended R&D.
Generalist
Adjacent materials rolehigh-pressure catheter balloons using pleat and fold processes; injection molding equipment; materials knowledge for fabrication
- Seniority
- Mid-level
- Work
- On-site
- Type
- Contract
- Degree
- BS
- Experience
- 5+ yrs
- Industry
- Medical devices
- Role
- Process Engineering
Role details
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.
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 SolidWork.
- Experience in Lean Manufacturing Six Sigma certification.
- Experience in ISO 13485/ISO 9000.
- IQ/OQ/PQ experience.
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