The Role
Leads manufacturing process design, qualification, validation, launch, and continuous improvement for drug-device combination products. Responsibilities include process and production layout design, lean initiatives, PFMEA/DFMEA, DFM, line validation, cost and capacity analysis, tooling strategy, documentation, and project management. The role collaborates cross-functionally on design transfer, product development, quality, production equipment troubleshooting, and compliance with Laborie’s QMS and ISO 13485 standards. Approximately 10% domestic or international travel is required.
Summary Generated by Built In
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.
- Establish and follow sound PMO fundamentals to ensure plans are detailed, clear, executable, and resourced correctly. Manage schedule, budget, and risk throughout project lifecycles; report on program status to stakeholders and executive leadership.
- 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 and 5+ years relevant experience in Biomedical, Mechanical, or Industrial Engineering or related field, or a master's degree with 3 years experience.
- Experience must include:
- Lean manufacturing methods and procedures
- Work in medical device or pharmaceutical environment
- Manufacturing, quality, and product development
- Project management (planning, scheduling, budgeting, etc.)
- Production equipment troubleshooting
- Excellent communicator, with ability to translate complex requirements and challenges into actional work activities
- Dynamic leader with mix of PM, Business and Technical skills
- Ability to work in compliance with Laborie 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
- Approximately 10% domestic and/or international travel required.
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 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.
Skills Required
- Bachelor’s degree in Biomedical, Mechanical, Industrial Engineering, or a related field with 5+ years of relevant experience; alternatively, a master’s degree with 3 years of experience.
- Experience with lean manufacturing methods and procedures.
- Experience working in a medical device or pharmaceutical environment.
- Experience in manufacturing, quality, and product development.
- Project management experience, including planning, scheduling, and budgeting.
- Production equipment troubleshooting experience.
- Excellent communication skills and ability to translate complex requirements into actionable work activities.
- Leadership capability combining project management, business, and technical skills.
- Ability to work in compliance with Laborie QMS, ISO 13485, and applicable standards for drug-device combination products.
- Collaborative team-building approach with a focus on performance and results.
- Approximately 10% domestic and/or international travel availability.
- Experience with complex catheter processes and equipment.
- Green Belt or Lean Six Sigma certification.
- Knowledge of technology transfer or product line transfer.
Am I A Good Fit?
Get Personalized Job Insights.
Our AI-powered fit analysis compares your resume with a job listing so you know if your skills & experience align.
Success! Refresh the page to see how your skills align with this role.
The Company
What We Do
Laborie develops innovative medical technologies – including diagnostic equipment and consumable supplies – in the Urology, Gastroenterology, Gynecology, Obstetrics and Neonatology fields. We take great pride in supporting doctors, nurses, hospitals, clinics, academic institutions and patients with treatment and diagnostic innovations. LABORIE is comprised of a variety of powerful brands – cultivated over more than 50 years of providing innovative products and services to our customers. Our story is one of continuous profitable growth, driven both organically and inorganically through mergers and acquisitions. We are privately owned by Patricia Industries and a part of the Investor AB network. Our owners take a long-term investment approach and create value for people and society by building strong and sustainable businesses. We know the work we do at LABORIE matters – we’re making a positive impact in the lives of patients across the globe. This is what fuels our motivation each day.
