Job OverviewLeads multidisciplinary Sustaining Engineering and Product Lifecycle Management teams to ensure the continued safety, quality, reliability, regulatory compliance, and profitability of commercially released products throughout their lifecycle. Directs and coordinates engineering activities related to design changes, product enhancements, component obsolescence, supplier changes, cost reduction initiatives, complaint investigations, CAPAs, and manufacturing support. Provides technical leadership and cross-functional collaboration to drive continuous improvement, product performance, operational excellence, and customer satisfaction while ensuring compliance with applicable regulatory and quality requirements.
Job Responsibilities and Essential Duties- Accountable for sustaining engineering deliverables across cost, schedule, quality, regulatory compliance, and product performance objectives.
- Lead sustaining engineering activities for commercially released medical devices throughout the product lifecycle.
- Serve as technical leader for design changes, product improvements, cost reduction initiatives, and issue resolution activities.
- Drive investigation and resolution of product field issues, complaints, nonconformances, corrective and preventive actions (CAPAs), and root cause analyses.
- Lead cross-functional teams in executing engineering change orders (ECOs), design changes, and product maintenance activities.
- Manage component obsolescence programs and develop mitigation strategies to ensure uninterrupted product availability.
- Partner with Supply Chain, Operations, Quality, Regulatory Affairs, Manufacturing, Service, and Supplier Quality organizations to support business continuity and product lifecycle objectives.
- Ensure system-level impact assessments are performed for product modifications, supplier changes, and manufacturing transfers.
- Oversee verification and validation activities associated with design changes and sustaining engineering projects.
- Maintain compliance with FDA, ISO 13485, IEC 60601, IEC 62304, ISO 14971, and other applicable international standards and regulations.
- Support internal and external audits, regulatory inspections, and regulatory submissions related to product changes.
- Drive continuous improvement initiatives focused on product quality, reliability, manufacturability, serviceability, and cost optimization.
- Monitor and analyze product performance metrics, complaint trends, reliability data, and field performance to identify improvement opportunities.
- Develop and execute lifecycle management strategies for mature products, including technology refresh, risk reduction, and end-of-life planning.
- Collaborate with ACT divisional R&D teams to leverage best practices, standard processes, and engineering tools.
- Lead and influence distributed global teams; align execution across regions and functions.
- Identify organizational capability gaps and ensure completion of training and development plans for direct reports.
- Manage departmental budgets, resource planning, and project prioritization to meet business objectives.
Minimum Requirements- Bachelor's degree in mechanical, Biomedical or Biomedical Engineering required, master's degree in engineering, Life Sciences, Business, or related field preferred.
- 10+ years of engineering experience within the medical device industry, including at least 5 years of leadership or management experience.
- Proven experience leading sustaining engineering, product lifecycle management, or post-market engineering activities in regulated environments.
- Experience supporting commercially released products through design changes, CAPAs, complaint investigations, risk management, and regulatory compliance activities.
- Demonstrated experience working within FDA, ISO 13485, CE Mark, and global regulatory frameworks.
- Experience in cardiovascular, critical care, acute care, or other complex medical device technologies preferred.
Required Knowledge, Skills and Abilities- Strong technical expertise in sustaining medical device engineering and product lifecycle management.
- Thorough understanding of design controls, risk management, change management, CAPA processes, and post-market surveillance requirements.
- Knowledge of medical device regulations and standards including FDA QSR, ISO 13485, IEC 60601, IEC 62304, and ISO 14971.
- Demonstrated leadership, people management, project management, and decision-making skills.
- Strong analytical and problem-solving capabilities with experience leading structured root cause investigations.
- Excellent communication, influence, negotiation, and presentation skills.
- Proven ability to collaborate effectively across global, cross-functional organizations.
- Ability to manage multiple priorities and deliver results in a fast-paced environment.
- Experience with product reliability, quality improvement, supplier management, and cost reduction initiatives.
Salary range: $190k - $215k; Target bonus: 25%
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Benefits at Getinge:At Getinge, we offer a comprehensive benefits package, which includes:
- Health, Dental, and Vision insurance benefits
- 401k plan with company match
- Paid Time Off
- Wellness initiative & Health Assistance Resources
- Life Insurance
- Short and Long Term Disability Benefits
- Health and Dependent Care Flexible Spending Accounts
- Commuter Benefits
- Parental and Caregiver Leave
- Tuition Reimbursement
