Role overview

We are seeking a Sustaining Engineering Manager to oversee post-market engineering activities and support the ongoing performance, reliability, quality, and compliance of In Vitro Diagnostic (IVD) medical devices. This role serves as a technical leader responsible for coordinating sustaining engineering efforts across cross-functional teams, ensuring timely resolution of field issues, implementation of product improvements, and management of component obsolescence throughout the product lifecycle.

The ideal candidate possesses strong hardware systems engineering experience within a regulated medical device environment and has demonstrated success leading technical teams and complex engineering initiatives. This individual will act as a key liaison between R&D, Quality, Regulatory, Manufacturing, and external suppliers to drive continuous product improvement while maintaining compliance with applicable standards and regulations.

Responsibilities

Lead cross-functional teams performing post-market sustaining engineering activities, including field issues, CAPAs, obsolescence, and product improvements
In collaboration with external vendors, design and develop hardware system architectures for IVD medical devices in accordance with design controls
Drive root cause investigations and corrective actions using structured problem-solving methodologies.
Lead component obsolescence management efforts, including risk assessments, redesign activities, supplier engagement, and implementation planning.
Prioritize and manage sustaining engineering projects, balancing business needs, customer impact, regulatory requirements, and resource constraints.
Collaborate with Quality and Regulatory teams to ensure compliance with design controls, change management processes, and quality system requirements.
Define and execute verification and validation activities associated with product changes, design updates, and sustaining engineering initiatives.
Facilitate technical reviews, FMEAs, engineering change assessments, and design review activities.
Partner with Manufacturing and Supply Chain teams to support production issues, yield improvements, supplier changes, and manufacturing process enhancements.
Provide technical oversight for engineering documentation, including Engineering Change Orders (ECOs), Design History Files (DHF), verification reports, risk management files, and technical investigations.
Collaborate with external suppliers and development partners to resolve technical issues and support product lifecycle management activities.
Support strategic planning for product lifecycle management, reliability improvements, and continuous improvement initiatives.

Required Qualifications

Bachelor's degree in Electrical Engineering, Computer Engineering, Biomedical Engineering, or a related technical discipline.

5+ years of experience in hardware systems engineering, sustaining engineering, product support engineering, or medical device development within a regulated environment.

Experience leading technical projects or cross-functional engineering teams.

Strong understanding of medical device design controls, engineering change management, and quality system requirements.

Experience managing CAPAs, complaint investigations, and post-market engineering activities.

Solid understanding of analog and digital electronics, system integration, troubleshooting, and root cause analysis.

Experience with verification, validation, and risk management activities.

Working knowledge of ISO 13485, ISO 14971, IEC 60601, and applicable medical device regulations.

Strong project management, organizational, communication, and stakeholder management skills.

Experience with design transfer, manufacturing support, and supplier quality activities.