Senior Manufacturing Engineer

We believe that great healthcare is an essential safeguard of human dignity. A t 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 product and updates to existing medical devices into manufacturing. The Senior Manufacturing Engineer will work closely with various stakeholders across multiple 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:

Design manufacturing processes, procedures and production layouts to optimize productivity, maintainability, quality, 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. Establishes and follows sound PMO fundamentals to ensure plans are detailed, clear, executable and resourced correctly; manage schedule, budget and risk throughout project lifecycles; reports on program status to stakeholders and executive leadership. Manage and support line validation/qualification activities including IQ, OQ, MSA and PQ, including authoring all related documentation, execution of testing protocols and writing summary reports. 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. Prepare documentation including testing protocols for product evaluations, work instructions, Control Plans, Manufacturing Processes, job safety analysis sheets, and product and process reports; create and review process flow charts, production tooling strategies, production line layouts, production capacity analysis and EHS project plans. 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. Influences and indirectly manages others across functional disciplines to ensure design transfers are achieved meeting all internal QMS and external regulatory requirements. Establish and maintain business relationships with internal stakeholders and external vendors.

Minimum Qualifications:

Master's degree or equivalent, in Mechanical Engineering or related field, with 3+ years relevant engineering experience or bachelor's degree or equivalent degree in Mechanical Engineering or related field and 5 years relevant engineering experience Experience must include: Lean manufacturing methods and procedures Working in medical device or pharmaceutical environment Manufacturing, quality and product development Project management (planning, scheduling, budgeting, etc.) Production equipment troubleshooting Dynamic leader with mix of PM, Business and Technical skills Excellent communicator, with ability to translate complex requirements and challenges into actional work activities Work in compliance with

QMS, ISO

13485, and other applicable standards related to drug-device combination products Team-building approach, being a collaborative leader while driving performance/goal-oriented results Experience with ERP systems Domestic travel 5-20% to other Laborie facilities, suppliers, or equipment vendors

Preferred Qualifications:

Experience with complex Catheter processes and equipment 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 2025 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.