Principal 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’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.

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.

Responsibilities

• 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.

Requirements

• 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%.

Qualifications

• Bachelor's in Mechanical, Electrical, or Manufacturing Engineering required.
• 12+ years' experience as Manufacturing/Production Engineer (or 8+ with Master's), preferably in medical device industry.
• 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%.

Skills

• Technical leadership and operational strategy guidance.
• Project management and cross-functional collaboration.
• Manufacturing process optimization and Lean implementation.
• Design transfer and production readiness.
• Validation and qualification activities (IQ, OQ, PQ, MSA).
• Data-driven insights through costs analysis, production planning, and reporting.

Benefits

• Paid time off and paid volunteer time.
• Medical, Dental, Vision, and Flexible Spending Account.
• Health Savings Account with Company Funded Contributions.
• 401(k) Retirement Plan with Company Match.
• Parental Leave and Adoption Services.
• Health and Wellness Programs and Events.
• Awarded 2025 Cigna Healthy Workforce Designation Gold Level.

Pay

Compensation is commensurate with experience.

Schedule

Full-time position.