- Design manufacturing processes, procedures and production layouts to optimize productivity, maintainability, and cost for drug-device combination products.
- Optimize drug coating process and coating equipment, process capabilities, prioritizes process improvement opportunities, and innovates and implements process improvements on platform or derivative projects.
- Assist project managers in estimating project timelines and optimizing development plans, creating and reviewing process flow charts, production tooling strategies, production line layouts and capacity analysis and EHS project plans.
- Actively participate in PFMEA, DFMEA, Process Mapping and Critical to Quality (CTQ) reviews assuring specifications are well defined and documented.
- Coordinate with cross functional teams, training and guiding others to implement new product designs and design updates to existing products. Facilitate implementation into production meetings for engineering changes.
- Provide manufacturing decision making information by calculating production, labor, and material costs and reviewing production schedules estimating future requirements.
- Participate in PFMEA, Process Mapping, and Critical to Quality (CTQ) reviews.
- Actively participate in Lean initiatives to stabilize production lines and reduce the time to transfer to Plant and improve manufacturing efficiency by analyzing and planning workflow, time studies, space requirements, soliciting observations from operators and equipment layout.
- Master's degree in Biomedical, Mechanical or Industrial Engineering or related field and 3+ years of experience or Bachelor's degree in Biomedical, Mechanical or Industrial Engineering, or equivalent, plus 5+ years of experience as Manufacturing Process Engineer, preferably in Medical Devices.
- Experience must include lean manufacturing methods and procedures, working with ISO 13485/ISO 9001, working in medical device environment, manufacturing quality and product development, ERP systems and project management.
- Knowledge of DFM (Design for Manufacturability), Six Sigma Green Belt certification and Lean Six Sigma certification
- 5% domestic and/or international travel potential
- 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
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Senior Manufacturing Engineer - Plymouth, United States - Laborie
Description
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 Senior Manufacturing Engineer will be responsible for assisting in the development, qualification, launch of new product and updates to existing medical devices into manufacturing. This role will work closely with several departments to ensure efficient design transfer processes and thrives in cross-functional teams. With experience in lean manufacturing environments and relevant product knowledge, the Senior Manufacturing Engineer helps improve manufacturing processes and explore new ideas.
About the Role:
Minimum Qualifications:
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.
We are interested in a qualified candidate who is eligible to work in the United States. However, we will not be sponsoring work visas for this position, at this time.
Laborieprovides 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.
