Manufacturing Engineer
About this role
- 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.
- 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%
- Catheter/balloon catheter experience
- Injection molding experience
- Experience in Lean Manufacturing – Six Sigma certification
- Experience in ISO 13485/ISO 9000
- IQ/OQ/PQ experience
- 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
Company at a glance
Laborie is a world-class specialist medical company that makes and advances technologies that preserve and restore human dignity. We take great pride in supporting doctors, nurses, hospitals, clinics, academic institutions and patients with treatment and diagnostic innovations. Our technologies include diagnostic equipment and consumable supplies in the Urology, Gastroenterology, Gynecology, Obstetrics and Neonatology fields.
Privately owned by Patricia Industries and a part of the Investor AB network, Laborie is comprised of powerful brands that have been cultivated for more than 50 years. As a rapidly growing and scaling organization, our company values drive our day-to-day behaviors and make us ONE Laborie whenever and wherever we do business. We know that the work we do matters and we’re making a positive impact in the lives of patients across the globe. This is what fuels our motivation each day.
If you’re ready to be part of a mission with meaning and a rewarding environment with opportunities for professional growth and career advancement, view our current job openings at https://www.laborie.com/about-us/careers/
Top Benefits
- Paid time off
- Paid volunteer time
- Medical insurance
- Dental insurance
- Vision insurance
- Flexible spending account
- Health savings account
- 401k retirement plan
- Parental leave
- Adoption services
- Health and wellness programs
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