Manufacturing Engineer

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 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 supports and enhances production operations by improving quality, reducing defects, and resolving non-conforming material issues within a controlled environment certified to ISO 9001 and regulated by ISO 13485. The Manufacturing Engineer plays a key part in the development, qualification, and launch of new products, as well as updates to existing medical devices, ensuring efficient and compliant design transfer into manufacturing. Working closely with cross-functional teams, the Manufacturing Engineer applies lean manufacturing principles, technical expertise, and strong problem-solving skills to optimize processes, drives continuous improvement, and introduces innovative ideas that enhance operational performance and product reliability.

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:

• Bachelor's degree, or equivalent, in Biomedical, Mechanical, or Industrial Engineering or related field, and 2+ years of experience as a Manufacturing Process Engineer
• Experience must include:
• Lean manufacturing methods and procedures
• Working with ISO 13485/ISO 9001
• Working in medical device environment, GMP practices
• Manufacturing quality and product development
• Project management
• Knowledge of DFM (Design for Manufacturability), Six Sigma Green Belt and Lean Six Sigma
• Working with ERP systems
• Strong problem-solving skills using structured methodologies (5-Why, Fishbone, DMAIC, etc.)
• Solid written and verbal communication skills; able to manage communication within cross functional teams and external contractors
• 5% domestic and/or international travel potential

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.