Lifecycle Engineering Leader: Sustaining & Post-Market

Getinge; Wayne (NJ); On-site; USD 190,000 - 215,000; Full time

Benefits offered by this job

Health benefits

401k with match

Paid time off

Wellness resources

Life Insurance

Disability benefits

FSAs

Parental leave

Tuition reimbursement

Job summary

Getinge is seeking a senior sustaining engineering leader in the United States to oversee multidisciplinary teams ensuring safety, quality, and profitability of medical devices throughout their lifecycle. You will direct design changes, CAPAs, supplier changes, and manufacturing support to drive improvements and regulatory compliance.

The role requires 10+ years in medical device engineering with at least 5 years in leadership, experience with FDA/ISO standards, and a focus on reliability, cost

Qualifications

• Bachelor's degree in mechanical, Biomedical or Biomedical Engineering required; master's preferred.
• 10+ years of engineering experience in the medical device industry, including at least 5 years in leadership or management.
• Experience leading sustaining engineering, product lifecycle management, or post-market engineering in regulated environments.
• Demonstrated experience with FDA, ISO 13485, CE Mark, and global regulatory frameworks.

Responsibilities

• 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.
• Drive investigation and resolution of product field issues, complaints, nonconformances, CAPAs, and root cause analyses.
• Lead cross-functional teams in executing ECOs, design changes, and product maintenance activities.
• Manage component obsolescence programs and mitigation strategies to ensure uninterrupted product availability.
• Collaborate with Supply Chain, Operations, Quality, Regulatory Affairs, Manufacturing, Service, and Supplier Quality.
• Ensure system-level impact assessments for product changes, supplier changes, and manufacturing transfers.
• Oversee verification and validation activities for design changes and sustaining projects.
• Maintain compliance with FDA, ISO 13485, IEC 60601, IEC 62304, ISO 14971 and other standards.
• Support audits, inspections, and regulatory submissions related to product changes.
• Drive continuous improvement in product quality, reliability, manufacturability, serviceability, and cost.
• Monitor product performance metrics and field data to identify improvements.
• Develop lifecycle management strategies for mature products including tech refresh and end-of-life planning.
• Collaborate with ACT R&D teams to share best practices and standard processes.
• Lead and influence distributed global teams across regions and functions.
• Identify capability gaps and ensure training for direct reports.
• Manage departmental budgets, resources, and project prioritization.

Skills

Sustaining engineering

Product lifecycle management

Leadership

Regulatory compliance

Cross-functional collaboration

Root cause analysis

Quality improvement

Education

Bachelors in engineering

Masters preferred

Job description

Getinge is seeking a senior sustaining engineering leader in the United States to oversee multidisciplinary teams ensuring safety, quality, and profitability of medical devices throughout their lifecycle. You will direct design changes, CAPAs, supplier changes, and manufacturing support to drive improvements and regulatory compliance.

The role requires 10+ years in medical device engineering with at least 5 years in leadership, experience with FDA/ISO standards, and a focus on reliability, cost