Sustaining Engineering Manager
Germany
Position 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.