Manufacturing Engineer

Manufacturing EngineerWe 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.About the Role: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.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 DevicesExperience using statistical analysis methods for process development and control, Minitab experience preferredProven experience in chemical and process engineeringWorking knowledge of process engineering software such as SolidWorksAbility to travel up to 25%Preferred Qualifications:Catheter/balloon catheter experienceInjection molding experienceExperience in Lean Manufacturing – Six Sigma certificationExperience in ISO 13485/ISO 9000IQ/OQ/PQ experienceWhy 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 timeMedical, Dental, Vision and Flexible Spending AccountHealth Savings Account with Company Funded Contributions401k Retirement Plan with Company MatchParental Leave and Adoption ServicesHealth and Wellness Programs and EventsLaborie 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.