Senior Manufacturing Engineer

ZEVEX Inc.; Salt Lake City (UT); Vor Ort; USD 100.000 - 125.000; Vollzeit

Benefits dieser Stelle

Profit sharing

401(k) match

Relocation assistance

Health insurance

Employee stock purchase plan

Flexible PTO

Zusammenfassung

Moog, a leader in advanced manufacturing, seeks a Senior Manufacturing Engineer to provide technical leadership in FDA-regulated medical device production in Salt Lake City. You will drive process development, validation, and optimization across production, quality, and regulatory activities.

You will lead CAPA and root-cause investigations, implement corrective actions, and advance Lean initiatives using SPC, Cp/Cpk, and Minitab.

Qualifikationen

• Bachelor’s degree in Engineering and 7+ years of manufacturing engineering experience.
• 5+ years of experience in FDA-regulated medical device manufacturing preferred.
• Experience leading IQ/OQ/PQ process validations.
• Strong knowledge of FDA QSR/QMSR, ISO 13485, and ISO 14971 requirements.
• Experience supporting CAPA, NCR, complaint investigations, and root cause analysis.

Aufgaben

• Provide technical leadership and mentorship to engineers, technicians, and manufacturing personnel.
• Lead development, qualification, validation, and optimization of manufacturing processes to support production, quality, and regulatory requirements, including IQ/OQ/PQ validation activities.
• Support CAPA, NCR, and complaint investigation activities by conducting root cause analysis and implementing corrective actions.
• Identify and implement process improvements that enhance manufacturing efficiency, quality, and operational performance.
• Lead design transfer and new product introduction activities, partnering with cross-functional teams to successfully transition products into manufacturing.
• Design and develop fixtures, tooling, and test equipment to improve manufacturing capability and process repeatability.
• Drive Lean Manufacturing and continuous improvement initiatives utilizing statistical methods and best practices.
• Support internal and external audits and ensure compliance with FDA and ISO quality system requirements.
• Manage capital equipment projects including specification development, procurement, implementation, and validation.

Kenntnisse

FDA-regulated manufacturing

IQ/OQ/PQ validation

CAPA/root cause analysis

Gage R&R

Minitab

Design for Manufacturability

DFM/Design Transfer

Six Sigma Green Belt/Black Belt

Cross-functional leadership

Ausbildung

Bachelor’s degree in Engineering

Tools

SolidWorks

Minitab

Jobbeschreibung

Job Summary

Moog is a performance culture that empowers people to achieve great things. Our people enjoy solving interesting technical challenges in a culture where everyone trusts each other to do the right thing.

For you, working with us can mean deeper job satisfaction, better rewards, and a great quality of life inside and outside of work.

Job Title: Senior Manufacturing Engineer

Reporting To: Manager, Operations Engineering

Work Schedule: Onsite - Salt Lake City, UT

The Senior Manufacturing Engineer provides technical leadership for manufacturing operations supporting FDA-regulated medical devices. Supporting production, quality, and new product introduction activities, this role is responsible for developing, validating, and optimizing manufacturing processes to ensure product quality, regulatory compliance, and operational efficiency.

Key priorities include leading manufacturing process validations, supporting quality system investigations, driving continuous improvement initiatives, managing capital equipment projects, and providing technical leadership across manufacturing operations. This position plays a critical role in ensuring compliance with FDA and ISO requirements while supporting the successful introduction and manufacture of medical device products.

Requirements

• Bachelor’s degree in an Engineering discipline and 7+ years of manufacturing engineering experience.
• 5+ years of experience in FDA-regulated medical device manufacturing preferred.
• Experience leading IQ/OQ/PQ process validations.
• Strong knowledge of FDA QSR/QMSR, ISO 13485, and ISO 14971 requirements.
• Experience supporting CAPA, NCR, complaint investigations, and root cause analysis activities.
• Proficiency with statistical analysis tools and methodologies including SPC, process capability analysis (Cp/Cpk), Gage R&R, DOE, and Minitab.
• Experience designing fixtures and implementing manufacturing process optimization initiatives.
• Proficiency with SolidWorks or equivalent 3D CAD software.
• Experience with Design for Manufacturability (DFM), Design Transfer, and new product introduction activities.
• Strong project management and leadership skills with the ability to lead cross-functional engineering projects.
• Six Sigma Green Belt or Black Belt certification is preferred.
• Experience with electromechanical medical devices and/or cleanroom manufacturing is preferred.

Responsibilities

• Provide technical leadership and mentorship to engineers, technicians, and manufacturing personnel.
• Lead the development, qualification, validation, and optimization of manufacturing processes to support production, quality, and regulatory requirements, including IQ/OQ/PQ validation activities.
• Support CAPA, NCR, and complaint investigation activities by conducting root cause analysis and implementing corrective actions.
• Identify and implement process improvements that enhance manufacturing efficiency, quality, and operational performance.
• Lead design transfer and new product introduction activities, partnering with cross-functional teams to successfully transition products into manufacturing.
• Design and develop fixtures, tooling, and test equipment to improve manufacturing capability and process repeatability.
• Drive Lean Manufacturing and continuous improvement initiatives utilizing statistical methods and best practices.
• Support internal and external audits and ensure compliance with FDA and ISO quality system requirements.
• Manage capital equipment projects including specification development, procurement, implementation, and validation.

Benefits & Perks

• Financial Rewards: Great compensation package, annual profit sharing, matching 401(k), Employee Stock Purchase Plan, Flexible Spending Accounts, and Health Savings Accounts.
• Work/Life Balance: Flexible paid time off, company holidays, parental leave program, and relocation assistance.
• Health & Welfare: Comprehensive medical, dental, vision, life, disability, Employee Assistance Program (EAP), and supplemental benefit coverage.
• Professional Skills Development: Tuition assistance, mentorship, coaching opportunities, leadership development programs, and ongoing career growth support.
• Collaborative and Welcoming Workplace: Inclusive culture rooted in our values, supported by Employee Resource Groups and team-building activities.
• Additional site-specific benefits may be available.

Compensation

Salary Range Transparency: Salt Lake City, UT $100,000.00-$125,000.00 Annually

Compliance & Eligibility

This position requires access to U.S. export-controlled information.

Moog offers an inclusive workplace, and, as such, affirms the right of every person to participate in all aspects of employment based on merit without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic.

If you are interested in applying for employment and need special assistance or an accommodation to apply for a posted position, contact our Human Resources department via phone at 844-367-5787.