The Role
Develops, validates, and improves medical device manufacturing processes for high-pressure catheter balloons. Responsibilities include process development, equipment installation and qualification, IQ/OQ/PQ validation, PFMEA risk management, statistical analysis, fixture and equipment design, production efficiency improvements, quality improvement, and support for new production line implementation.
Summary Generated by Built In
We believe that great healthcare is an essential safeguard of human dignity.
At Laborie, we know the work we do matters – it’s what fuels our motivation and contributes to our success. If you’re ready to make a positive impact in the lives of patients across the globe, we’d like to meet you.
We support and empower our employees to grow their careers in an environment that encourages a sense of belonging and a connection to doing good. We’re not afraid to roll up our sleeves to make our goals a reality and work together to solve for our customers. We reward and recognize our employees based on our values of Aspire to Greatness, Respect All, Own It, Working Together, Persist with Passion.
Who We’re Looking For:
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.
About the 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.
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
Why Laborie:
Our Mission every day is to operate as a world-class specialist medical company making and advancing technologies that preserve and restore human dignity. We do that today by helping people with pelvic and gastrointestinal conditions live normal lives, and by helping mothers and babies have safe deliveries.
- 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
Laborie provides equal employment opportunities and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Laborie is committed to providing access and reasonable accommodation in our services, activities, education, and employment for individuals with disabilities.
Skills Required
- Bachelor's degree in Biomedical, Mechanical, or Industrial Engineering, or equivalent
- 5 or more years of experience as a Manufacturing Process Engineer, preferably in medical devices
- Experience using statistical analysis methods for process development and control
- Minitab experience
- Proven experience in chemical and process engineering
- Working knowledge of process engineering software such as SolidWorks
- Ability to travel up to 25%
- Catheter or balloon catheter experience
- Injection molding experience
- Lean Manufacturing or Six Sigma certification
- Experience with ISO 13485 or ISO 9000
- IQ/OQ/PQ experience
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The Company
What We Do
Laborie develops innovative medical technologies – including diagnostic equipment and consumable supplies – in the Urology, Gastroenterology, Gynecology, Obstetrics and Neonatology fields. We take great pride in supporting doctors, nurses, hospitals, clinics, academic institutions and patients with treatment and diagnostic innovations. LABORIE is comprised of a variety of powerful brands – cultivated over more than 50 years of providing innovative products and services to our customers. Our story is one of continuous profitable growth, driven both organically and inorganically through mergers and acquisitions. We are privately owned by Patricia Industries and a part of the Investor AB network. Our owners take a long-term investment approach and create value for people and society by building strong and sustainable businesses. We know the work we do at LABORIE matters – we’re making a positive impact in the lives of patients across the globe. This is what fuels our motivation each day.
