Sustaining Engineering Manager

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.