Sustaining Engineering Manager

Sustaining Engineering ManagerGermanyPosition Objective:Manage and develop timelines and budgets for sustaining engineering (SE) projects.Collaborate with internal and external partners.Mentor and guide SE engineers through project stages.Ensure assembly and subassembly functionality, manufacturability, and reliability via partnerships.Document and coordinate testing to characterize and qualify concepts/products with risk management and quality focus.Provide clarity of mission, critical objectives, and corporate alignment.Drive engagement through communication and cross-functional collaboration.Offer technical expertise for product development.Principal Responsibilities:Lead SE technical projects.Head design changes to released products to enhance performance, quality, compliance, and cost-efficiency.Ensure project planning, development plans, FMEA, risk management, and V&V testing align with FDA/MDR.Advise senior management on technology development or outsourcing.Develop and execute design verification and validation test plans.Address non-conformances, CAPAs, and complaints.Recruit and manage high-performing personnel.Key Result Areas:Maintain international product approvals and implement changes.Deliver credible schedules and health reports.Lead projects to meet objectives on time and within budget.Create robust technical documentation.Be a subject matter expert in PM, analytics, and engineering.Promote a culture of accountability, feedback, and growth.Qualifications:BS in Engineering (preferably Medical/Biomedical); MS/PhD/MBA preferred.7+ years in medical device development (capital equipment, disposables, implants). Experience with FDA, ISO, GMP, and design control. Proven leadership in complex development projects. Skilled in in vitro/in vivo/in situ/ex vivo testing. Team building, conflict resolution, budgeting, and timeline creation. Strong written/oral communication and technical translation skills. Hands-on leadership style.