
Senior Manufacturing Engineer
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Job overview
The Senior Manufacturing Engineer provides technical leadership for manufacturing operations supporting FDA-regulated medical devices. The role develops, validates, and optimizes manufacturing processes; supports production, quality, and new product introduction; and leads process validations, quality investigations, continuous improvement, and capital equipment projects. It also supports compliance with FDA and ISO requirements and the successful introduction and manufacture of medical device products.
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Full job description
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. To be considered for the Senior Manufacturing Engineer role, here's what you'll typically need to bring with you: * 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 RandR, 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. As a Senior Manufacturing Engineer, you will: * 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. How we... For full info follow application link. EOE/AA Minority/Female/Sexual Orientation/Gender Identity/Disability/Veteran
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