Sr. 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.Essential Job Functions:Passion:Passion:People & Technical LeadershipLead 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 ExcellenceChampion 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 LeadershipEnsure 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 engagementsContinuous Improvement & Risk ManagementPartner 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 ActionLead and support root cause investigations, CAPAs, and continuous improvement initiatives to eliminate defects, reduce variation, and prevent recurrence.Project & Resource ManagementPrioritize and balance engineering and quality workloads to support production needs, NPI, and strategic initiatives.Collaboration:Cross-Functional PartnershipAlign 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 capabilitiesDeep technical expertise in machining-intensive manufacturing environments (CNC turning, Swiss lathes, CNC grinding, secondary operations) and quality inspectionExpertise in root cause analysis, CAPA, PFMEA, control plans, and validationStrong project management, prioritization, and decision-making skillsAbility to interpret data, manage risk, and drive fact-based decisionsExcellent communication skills; ability to influence across levels and functionsExperience:8-12+ years of experience in machining-focused manufacturing engineering within a regulated or high-precision environment (medical device, aerospace, automotive, or similarpreferred)5+ years of people leadership or technical team leadership experienceDemonstrated hands-on experience with CNC machining processes, including process development, troubleshooting, and production supportExperience with regulated manufacturing environment and quality systems such as ISO 13485 or FDA QSR, GxP, validation protocols, and audit readinessEducation: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 periodsOccasional 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 teamsReporting Structure:This position reports to the Director of Engineering