Principal Manufacturing Engineer

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

• Minimum of 12 years' experience as Manufacturing/Production Engineer (or 8+ with Master's), preferably in medical device industry;
• Bachelor's degree in Mechanical, Electrical, or Manufacturing Engineering;
• 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 strategic guidance;
• Project management and cross-functional collaboration;
• Lean Manufacturing and continuous improvement;
• ERP systems (SAP preferred);
• SolidWorks and Microsoft Office tools;
• Design for Manufacturability (DFM) principles;
• ISO 13485/ISO 9000 standards and health & safety regulations;
• Data-driven insights and cost analysis;
• Manufacturing operations and quality assurance;
• Product development and design changes;
• Validation and qualification activities;
• Leadership and mentoring of junior engineers.

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.