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Sr. Manager, Sustaining & LifeCycle Engineering

Job in Wayne, Passaic County, New Jersey, 07474, USA
Listing for: Getinge
Full Time position
Listed on 2026-09-02
Job specializations:
  • Engineering
    Regulatory Compliance Specialist
  • Management
    Regulatory Compliance Specialist
Salary/Wage Range or Industry Benchmark: 190000 - 215000 USD Yearly USD 190000.00 215000.00 YEAR
Job Description & How to Apply Below

With a passion for life

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers.

Are you looking for an inspiring career? You just found it.

Job Overview

Leads 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…
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