Engineering Assoc Manager
About The Position
The Engineering Associate Manager leads manufacturing engineering activities across assigned operations, including process development and validation, equipment management, continuous improvement, quality system compliance, and operational support. The role provides leadership and direction to engineers, technicians, and other technical personnel to help achieve safety, quality, delivery, and cost objectives. It also leads complex engineering initiatives and cross-functional projects supporting operational excellence, business growth, and regulatory compliance. The manager works in collaboration with the Engineering Director and serves as a technical leader across manufacturing operations. Responsibilities include developing and sustaining manufacturing processes, leading equipment and improvement initiatives, supporting product introductions and validation, and maintaining quality and regulatory compliance.
Requirements
- Bachelor’s degree in engineering or computer science; alternatively, a bachelor’s degree in another field with related certifications (e.g., CMM, CQE) plus 5–7 years of experience in engineering, quality, or regulatory compliance.
- Extensive knowledge of the Quality System Regulation and associated regulations and standards.
- Experience with control procedures, including the Change Management System, Nonconformance Reports, Engineering Specifications, CAPA, and Work Instructions.
- Exceptional written and verbal communication, high-level technical expertise, tact, and discretion, and the ability to keep management appropriately informed.
Nice To Haves
- At least one year of experience managing a team.
- Direct experience in the medical device industry.
Responsibilities
- Collaborate with the Engineering Director.
- Plan, prioritize, and review work assignments.
- Coach, mentor, and develop engineers, technicians, and programmers.
- Build an engaged, high-performing engineering team.
- Serve as a technical leader across manufacturing operations.
- Develop, improve, validate, and sustain manufacturing processes.
- Lead manufacturing and End-Of-Line improvements.
- Drive improvements in quality, throughput, scrap reduction, and cost.
- Use statistical methods and continuous improvement tools.
- Monitor manufacturing performance.
- Lead or support the VIP and cost-saving program across manufacturing sites.
- Solve complex manufacturing and process issues.
- Lead equipment acquisition, implementation, and optimization.
- Support new product introductions and validation activities.
- Lead large cross-functional engineering projects.
- Strengthen production and process controls and validation acumen.
- Lead CAPA, nonconformance, and change management activities.
- Maintain compliance with GMP, ISO, MDR/MDD, and internal quality systems.
- Support audits and regulatory inspections.
Benefits
- Development opportunities
- Employee resource groups (ERGs)
- Flexible working environment
- Location-specific competitive total rewards
- Wellness incentives
- Culture of recognition and performance awards
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What This Job Offers
Job Type
Full-time
Career Level
Manager
