Manufacturing Engineer

About the Role

The Manufacturing Engineer will support process development, validation, and integration of medical device manufacturing. Work will focus on process development, control, test methods, and transition from bench/pilot to full-scale manufacturing.

• Evaluate and develop manufacturing processes, design and conduct research programs; apply knowledge of product design, fabrication, assembly, tooling, and materials; confer with equipment vendors; solicit observations from operators.
• Responsible for the 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 the Manufacturing Supervisor by providing manufacturing decision-making information; calculating production, labor, and material costs; reviewing production schedules; estimating future requirements.

Qualifications

Minimum Qualifications

• 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%.

Preferred Qualifications

• Catheter/balloon catheter experience.
• Injection molding experience.
• Experience in Lean Manufacturing – Six Sigma certification.
• Experience in ISO 13485/ISO 9000.
• IQ/OQ/PQ experience.

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.