Principal Manufacturing Engineer

Laborie; Maple Grove (MN); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Paid time off

Volunteer time off

Medical insurance

HSA contributions

401k with match

Parental leave

Job summary

Laborie is seeking a Principal Manufacturing Engineer to shape manufacturing strategy across sites. You will lead high-impact projects, optimize processes, and mentor engineering teams while ensuring design transfer and production readiness for new products and updates.

You will drive validation activities and maintain compliance with ISO standards, delivering data-driven insights through planning and performance trend analysis.

Qualifications

• 12+ years' experience as Manufacturing/Production Engineer, or 8+ with Master's.
• Experience in medical device industry and DFM principles.
• Proficient with ERP SAP, SolidWorks, and MS Office.
• Lean manufacturing and continuous improvement experience.
• Knowledge of ISO 13485/ISO 9000 and health & safety regulations.
• Willingness to travel 25%.

Responsibilities

• Act as corporate SME, providing technical leadership and advising on strategy.
• Lead cross-functional projects with executive alignment to growth plans.
• Improve efficiency through Lean initiatives, line layouts, and time studies.
• Own design transfer and production readiness; mentor technicians and engineers.
• Lead IQ, OQ, PQ, MSA validation activities per ISO standards.
• Define testing methods and standards to ensure regulatory compliance and quality.

Skills

SAP ERP

SolidWorks

Microsoft Office

Lean Manufacturing

Data analysis

Project leadership

Education

Bachelor's in Mechanical, Electrical, or Manufacturing Engineering

Master's degree preferred

Job description

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 Manufacturing team, the Principal Manufacturing Engineer will assist in creating strategies and systems which allow all Laborie sites to assess operational needs. The role will aid others in investigating, recommending and implementing improvements include process, equipment, and automation used in manufacturing. The Principal Manufacturing Engineer is a highly experienced, professional recognized as a submit matter expert across the organization, influencing company-wide operations strategies, drives functional initiatives, and will mentor junior engineers.

About the Role:

• Act as corporate SME, providing technical leadership, guiding operational strategy, and advising on new product development and design changes.
• Lead high-impact, cross-functional projects, partnering with executive leadership to align manufacturing initiatives with business objectives and growth strategies, including acquisition evaluations.
• Drive manufacturing excellence and efficiency by optimizing workflows, conducting time studies, improving line layouts, implementing Lean initiatives to reduce cycle time and stabilize production.
• Own design transfer and production readiness, collaborating cross-functionally to implement new products and updates while training and mentoring technicians and engineering teams.
• Lead validation and qualification activities (IQ, OQ, PQ, MSA) ensuring compliance with ISO standards and robust process capability.
• Improve product and process quality by defining testing methods, establishing standards, and ensuring manufacturing processes meet regulatory and performance requirements.
• Provide data-driven insights through costs analysis, production planning, and reporting, including labor/material forecasting and performance trend analysis.

Minimum Qualifications:

• 12+ years' experience as Manufacturing/Production Engineer (or 8+ with Master's), preferably in medical device industry; Bachelor's in Mechanical, Electrical, or Manufacturing Engineering required.
• Proven expertise in manufacturing operations, quality, and product development, including Design for Manufacturability (DFM) principles.
• Hands-on experience with ERP systems (SAP preferred), SolidWorks, and Microsoft Office tools.
• Strong background in Lean Manufacturing methodologies and continuous improvement practices.
• Demonstrated ability to lead projects, meet tight deadlines, and collaborate effectively with cross-functional teams.
• Working knowledge of ISO 13485/ISO 9000 standards, health & safety regulations, and strong organizational/time management skills.
• Ability to travel 25%

Why Laborie:

• 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.