Engineering Manager

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