Senior Manufacturing Engineer
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 is responsible for assisting in the development, qualification, launch of new products and updates to existing medical devices into manufacturing. The Senior Manufacturing Engineer thrives in cross-functional teams, and they will work closely with various stakeholders across multiple departments to ensure efficient design transfer processes. 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:
- Design manufacturing processes, procedures, and production layouts to optimize productivity, maintainability, and cost for drug-device combination products.
- Optimize drug coating, manufacturing, and packaging processes, improve process capabilities, prioritize process improvement opportunities, and innovate and implement process improvements on platform or derivative projects.
- Actively participate in PFMEA, DFMEA, Process Mapping, and Critical to Quality (CTG) reviews assuring specifications are well defined and documented; participate/lead Design for Manufacturing (DFM) activities to verify manufacturability of Product Designs.
- Manage and support line validation/qualification activities including IQ, OQ, MSA and PQ, including authoring all related documentation and execution of testing protocols.
- Actively participate in Lean initiatives to stabilize production lines, reduce waste, and improve manufacturing efficiency. Calculate production, labor, and material costs and review production schedules to make data-based decisions for improvements.
- Create and review process flow charts, production tooling strategies, production line layouts, production capacity analysis, and EHS project plans.
- Prepare documentation including: testing protocols for product evaluations, work instructions, Control Plans, Manufacturing Processes, job safety analysis sheets, and product and process reports.
Minimum Qualifications:
- Master's degree, or equivalent, in Biomedical, Mechanical, or Industrial Engineering or related field, and 5 years relevant experience, or Bachelor's degree and 8+ years relevant experience
- Experience must include:
- Manufacturing, quality, and product development
- Experience with catheters, balloon catheters, bonding processes, including manufacturing and testing processes
- Preferred knowledge of combination medical devices and injection molding processes
- Working with ISO 13485/ISO 9001
- Working within a controlled medical device environment
- Proven experience and knowledge in design controls, device design and development standards, FDA regulation, GMP practices and QSR requirements
- Project management skills including development of project plans, schedules and budgets, including strong communication skills, ability to manage communication with cross functional teams and external contractors and ability to effectively present technical information.
- Working knowledge of DFM (Design for Manufacturability), Six Sigma, and Lean manufacturing practices.
- Strong hands-on technical aptitude, with ability to troubleshoot equipment, recommend corrective actions and implement solutions
- 25-50% domestic travel first year; approximately 10% domestic and/or international travel after year one.
Preferred Qualifications:
- Green Belt certification and Lean Six Sigma certifications
- Knowledge of technology transfer/product line transfer
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
- Awarded 2024 Cigna Healthy Workforce Designation Gold Level
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.