Medical Device Sustaining & Lifecycle Leader

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

Benefits offered by this job

Health insurance

401k with company match

Paid Time Off

Tuition Reimbursement

Job summary

Getinge is seeking a senior leader to guide multidisciplinary Sustaining Engineering and Product Lifecycle Management teams, ensuring the safety, quality, regulatory compliance, and profitability of marketed medical devices across their lifecycle.

You will direct design changes, ECOs, CAPAs, and field issue investigations, partnering with Supply Chain, Quality, Regulatory, Manufacturing and Service to drive improvements and ensure uninterrupted product availability.

Qualifications

• Bachelor's degree in mechanical or biomedical engineering.
• 10+ years in medical device engineering with leadership experience.
• Experience in sustaining engineering and post-market activities in regulated environments.
• Experience with FDA QSR, ISO 13485, CE Mark, and global regulatory frameworks.

Responsibilities

• Lead 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, CAPAs, and root cause analyses.
• Lead cross-functional teams in ECOs, design changes, and product maintenance activities.
• Manage component obsolescence programs and develop mitigation strategies for uninterrupted product availability.
• Partner with Supply Chain, Operations, Quality, Regulatory Affairs, Manufacturing, Service, and Supplier Quality organizations.

Skills

Sustaining Eng.

Product Lifecycle

Leadership

Regulatory Compliance

CAPA investigations

Education

Bachelor's degree in Mechanical/Biomedical Engineering

Master's degree preferred

Job description

Getinge is seeking a senior leader to guide multidisciplinary Sustaining Engineering and Product Lifecycle Management teams, ensuring the safety, quality, regulatory compliance, and profitability of marketed medical devices across their lifecycle.

You will direct design changes, ECOs, CAPAs, and field issue investigations, partnering with Supply Chain, Quality, Regulatory, Manufacturing and Service to drive improvements and ensure uninterrupted product availability.