Oxenham Group
Our client, a leader in precision medical device components and assemblies, is seeking an
Engineering Manager
to oversee their engineering team in Salt Lake City. This role is critical to driving operational excellence, product quality, and innovation across manufacturing lines. The Engineering Manager will be responsible for leading a team of engineers and technicians, ensuring projects are executed on time, within budget, and in compliance with ISO 13485 and FDA regulations. Key Responsibilities
Lead and mentor a team of design, process, and manufacturing engineers. Develop and implement engineering strategies to improve product quality, throughput, and cost efficiency. Oversee validation activities, process development, and equipment qualifications in compliance with regulatory requirements. Collaborate with Quality, Operations, and Regulatory teams to ensure design and production readiness. Manage new product introduction (NPI) activities, from prototype through scale-up and transfer to production. Partner with cross-functional leaders to resolve technical challenges and ensure continuous improvement. Establish and maintain engineering documentation including work instructions, validation protocols, and process flows. Track and report key engineering metrics including yield, scrap, cycle times, and project milestones. Support audits and ensure engineering compliance with ISO, FDA, and customer requirements. Qualifications
Bachelor's degree in Mechanical, Manufacturing, or related Engineering discipline (Master's preferred). 7+ years of engineering experience in medical device, aerospace, or precision manufacturing industries. 3+ years in a leadership or people-management role. Strong understanding of ISO 13485, FDA 21 CFR Part 11/820, and risk management principles. Proven experience with validation (IQ, OQ, PQ), root cause analysis, and CAPA systems. Demonstrated success in managing cross-functional teams and delivering complex projects. Excellent communication, leadership, and problem-solving skills. Why Join the Client?
Be part of a growing medical device manufacturing organization. Lead an experienced, driven engineering team with opportunities for innovation. Competitive salary, performance-based incentives, and comprehensive benefits package.
Engineering Manager
to oversee their engineering team in Salt Lake City. This role is critical to driving operational excellence, product quality, and innovation across manufacturing lines. The Engineering Manager will be responsible for leading a team of engineers and technicians, ensuring projects are executed on time, within budget, and in compliance with ISO 13485 and FDA regulations. Key Responsibilities
Lead and mentor a team of design, process, and manufacturing engineers. Develop and implement engineering strategies to improve product quality, throughput, and cost efficiency. Oversee validation activities, process development, and equipment qualifications in compliance with regulatory requirements. Collaborate with Quality, Operations, and Regulatory teams to ensure design and production readiness. Manage new product introduction (NPI) activities, from prototype through scale-up and transfer to production. Partner with cross-functional leaders to resolve technical challenges and ensure continuous improvement. Establish and maintain engineering documentation including work instructions, validation protocols, and process flows. Track and report key engineering metrics including yield, scrap, cycle times, and project milestones. Support audits and ensure engineering compliance with ISO, FDA, and customer requirements. Qualifications
Bachelor's degree in Mechanical, Manufacturing, or related Engineering discipline (Master's preferred). 7+ years of engineering experience in medical device, aerospace, or precision manufacturing industries. 3+ years in a leadership or people-management role. Strong understanding of ISO 13485, FDA 21 CFR Part 11/820, and risk management principles. Proven experience with validation (IQ, OQ, PQ), root cause analysis, and CAPA systems. Demonstrated success in managing cross-functional teams and delivering complex projects. Excellent communication, leadership, and problem-solving skills. Why Join the Client?
Be part of a growing medical device manufacturing organization. Lead an experienced, driven engineering team with opportunities for innovation. Competitive salary, performance-based incentives, and comprehensive benefits package.