Production Eng Manager, 5.5 Value Stream

Job Summary

The Production Engineering Manager will oversee the technical support of production operations, improvement and validation of manufacturing processes, tooling, and fixtures in order to meet daily production schedules, while mentoring team members, reducing defects and enhancing productivity and product quality.

Duties & Responsibilities

• Lead, coach, and develop Production Engineers by assigning work, managing performance, and fostering technical growth and continuous improvement.
• Anticipate and resolve manufacturing challenges through engineering expertise, data-driven decision-making, and industry best practices.
• Ensure compliance with all quality, regulatory, health, safety, environmental (HSE), and company requirements, including FDA QSR, ISO standards, GMP/GDP, and applicable policies and procedures.
• Partner with Quality to drive CAPAs, nonconformance reduction, audit readiness, investigations, and timely implementation of corrective actions.
• Qualify, optimize, and monitor manufacturing processes using validation activities (IQ/OQ/PQ), statistical tools, SPC, DOE, Gage R&R, and process capability studies.
• Establish, monitor, and improve key performance indicators (KPIs) such as safety, quality, yield, productivity, and equipment uptime.
• Lead continuous improvement initiatives using Lean Six Sigma principles, evaluating resource requirements, ROI, and implementation timelines.
• Support production operations, process transfers, and global collaboration to ensure business objectives are achieved on time.
• Develop, maintain, and improve manufacturing documentation, including work instructions, procedures, BOMs, process flows, routers, travelers, and PFMEAs.
• Plan and execute engineering projects, managing schedules, budgets, resources, and deliverables aligned with business goals.
• Communicate risks, issues, and opportunities to leadership and key stakeholders in a timely manner.

Experience and Education

• Bachelor’s degree in engineering required; Master's degree or MBA preferred.
• Equivalent combination of education and experience will be considered.
• 6+ years of manufacturing experience, preferably in the medical device industry and/or cleanroom environment.
• Demonstrated leadership, people management, or complex project management experience preferred.

Required Knowledge, Skills, Abilities, Certifications/Licenses and Affiliations

• Strong knowledge of FDA QSR, ISO standards, and applicable regulatory requirements.
• Strong analytical and problem-solving skills with experience using Lean Manufacturing, Six Sigma, Kaizen, statistical tools, and data-driven decision-making to improve manufacturing processes and performance.
• Six Sigma Black Belt preferred.
• Strong verbal and written communication skills with the ability to effectively collaborate across functions and organizational levels.
• Demonstrated ability to exercise sound technical judgment and independently solve complex manufacturing and process-related challenges.
• Proficiency with Microsoft Office applications; SAP experience preferred.

Benefits

• Medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
• Pension and savings plan (401k).
• Long-term incentive program.
• Vacation – up to 120 hours per calendar year.
• Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year.
• Holiday pay, including Floating Holidays – up to 13 days per calendar year.
• Work, Personal and Family Time - up to 40 hours per calendar year.

Pay

The anticipated base pay range for this position is: $102,000-$177,000. The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan.