What are the responsibilities and job description for the Senior Engineering Manager position at Medical equipment manufacturing?
Essential Job Functions:
Passion:
- 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: 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
Work Location: In person