Engineering Manager

**The Senior Engineering Manager is a strategic and hands-on leader responsible for setting direction and developing a team of Manufacturing Engineers (MEs) and Quality Engineers (QEs) to support safe, compliant, and efficient production in a regulated manufacturing environment. This role provides technical, people, and organizational leadership across manufacturing processes,

inspection strategy, and continuous improvement while ensuring alignment with business objectives, customer requirements, and regulatory standards.**

Passion

Essential Job Functions:

• Passion:

+ People \& Technical Leadership Lead and develop Manufacturing and Quality Engineers to build strong technical capability, accountability, and engagement. Foster a culture of ownership and continuous learning while strengthening technical depth, decision-making rigor, and succession readiness.

+ Operational \& Business Excellence Champion engineering and quality excellence through disciplined execution, robust processes, and proactive risk management. Ensure engineering resources are effectively aligned to support production, NPI, CapEx, and strategic initiatives.

• Trustworthiness:

+ Quality Leadership Ensure manufacturing and quality engineering activities comply with applicable regulatory and quality system requirements (e.g., ISO 13485, FDA QSR, GxP). Serve as a trusted leader for audits, inspections, and customer quality engagements

+ Continuous Improvement \& Risk Management Partner cross-functionally to deliver responsive, data-driven engineering and quality support. Serve as the escalation point for complex process, quality, and customer issues, ensuring disciplined change management to protect quality and delivery.

• Drive Results:

+ Problem Solving \& Corrective Action Lead and support root cause investigations, CAPAs, and continuous improvement initiatives to eliminate defects, reduce variation, and prevent recurrence.

+ Project \& Resource Management Prioritize and balance engineering and quality workloads to support production needs, NPI, and strategic initiatives.

• Collaboration:

+ Cross-Functional Partnership Align engineering and quality efforts with site and company objectives through strong cross-functional partnership. Lead engineering and quality execution for NPI, ensuring manufacturability, robust validation, and scalable inspection strategies.

Skills

• Strong people leadership and coaching capabilities
• Deep technical expertise in machining-intensive manufacturing environments (CNC turning, Swiss lathes, CNC grinding, secondary operations) and quality inspection
• Expertise in root cause analysis, CAPA, PFMEA, control plans, and validation
• Strong project management, prioritization, and decision-making skills
• Ability to interpret data, manage risk, and drive fact-based decisions
• Excellent communication skills; ability to influence across levels and functions

Experience

• 8-12\+ years of experience in machining-focused manufacturing engineering within a regulated or high-precision environment (medical device, aerospace, automotive, or similar preferred)
• 5\+ years of people leadership or technical team leadership experience
• Demonstrated hands-on experience with CNC machining processes, including process development, troubleshooting, and production support
• Experience with regulated manufacturing environment and quality systems such as ISO 13485 or FDA QSR, GxP, validation protocols, and audit readiness

Education

• Education: Bachelor’s degree in Mechanical Engineering, Manufacturing Engineering, or related technical field.
• Licenses/Certification: Certifications such as Six Sigma, Lean Manufacturing, or ASQ credentials preferred.
• Technology/Equipment: Microsoft Office Applications and familiarity with manufacturing software systems (MES, ERP, process monitoring tools)

Physical Demands

• Ability to work in both office and manufacturing environments for extended periods
• Occasional lifting and/or moving of up to 20 lbs. (fixtures, tooling, small equipment)
• Must be able to wear Personal Protective Equipment (PPE) as required in manufacturing areas.
• Excellent visual acuity for inspection, reading drawings, and reviewing documentation.
• Ability to hear and communicate clearly in meetings, on calls, and during team discussions.

Working Conditions

• Primarily office-based with regular time spent on the production floor and in controlled manufacturing environments.
• Standard Monday–Friday schedule, with flexibility to support production needs or project milestones.
• Frequent interaction with manufacturing equipment, processes, and cross-functional teams

Reporting Structure

This position reports to the Director of Engineering