Laborie · 8 hours ago
Senior Manufacturing Engineer
Plymouth, MN
Full-time
Onsite
Senior Level
5+ years expLaborie is a specialist medical company focused on advancing technologies that preserve and restore human dignity. The Senior Manufacturing Engineer will assist in the development and launch of medical devices into manufacturing, working closely with cross-functional teams to optimize processes and improve manufacturing efficiency.
Health CareManufacturingMedical
Responsibilities
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
Qualification
Required
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
Green Belt certification and Lean Six Sigma certifications
Knowledge of technology transfer/product line transfer
Benefits
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
Company
Laborie
Laborie is a world-class specialist medical company that makes and advances technologies that preserve and restore human dignity.
1001-5000 employees
H1B Sponsorship
Laborie has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (6)
2023 (3)
2022 (3)
2021 (2)
2020 (2)
Funding
Current Stage
Late StageTotal Funding
unknownKey Investors
Audax Private Equity
2016-08-19Acquired
2012-07-19Private Equity
Leadership Team
Bo Jesper Hansen
Non Executive Director
Ray Laborie
Consultant for distributors of medical devices
Recent News
Precedence Research
2025-11-21
2025-11-15
2025-11-08
Company data provided by crunchbase