R&D Engineering Manager - Medical Device - Sarnova

Overview

The R&D Engineering Manager will be responsible for maintaining, improving, and supporting existing and new medical device products throughout their lifecycle. The Engineering Manager role will be a hands on player/coach role.

Sarnova is the leading national specialty distributor of health care products in Emergency Medical Services (EMS) and Respiratory Markets and is the industry leader in Revenue Cycle Management within Emergency Medical Services (EMS). The company operates through several market-leading companies including Tri-anim Health Services, the largest specialty distributor of respiratory products, Bound Tree Medical, the largest supplier of EMS products, and Cardio Partners, a full Sudden Cardiac Arrest Solution provider, and Digitech, the leader in EMS revenue cycle management. Join a $1Billion+ high growith health care organization with over 1600 employees nationwide.

M-TH Dublin office based, Fridays remote

Responsibilities

Summary:

The R&D Engineering Manager is a player/coach role and will also be responsible for building a team responsible for maintaining, improving, and supporting existing medical device products throughout their lifecycle. This role ensures continued compliance with regulatory standards, drives cost and quality improvements, manages design changes, and supports manufacturing and field operations. The manager will collaborate cross-functionally with Quality, Regulatory, Operations, Product Management to sustain reliable, compliant, and high-performing products in the market.

Organizational Impact:

What you do each day matters. In this role you have the opportunity to influence the organizational strategy and direction from within a rapidly growing business unit.

Essential Duties and Responsibilities:

• Build, lead and develop a high-performing engineering team, driving talent acquisition, engagement, and growth.
• Execute complex projects with accountability for planning, budgeting, staffing, and delivery of results.
• Apply problem-solving and process improvement methodologies to resolve technical and business challenges.
• Influence cross-functional teams and senior leaders through clear, strategic communication.
• Ensure compliance with medical device regulations and design control standards.
• Oversee post-market product support, including design changes, component obsolescence, and supplier transitions.
• Drive continuous improvement initiatives to enhance product reliability, manufacturability, and cost-effectiveness.
• Lead investigations and root cause analysis for field issues, CAPAs, and nonconformances.
• Manage engineering change orders (ECOs) and documentation updates in compliance with design control requirements.
• Partner with Quality and Regulatory teams to ensure products remain compliant with global medical device regulations (FDA, ISO 13485, EU MDR).
• Work closely with Manufacturing and Supply Chain to resolve production issues, implement process improvements, and manage supplier changes.
• Ensure all sustaining engineering activities adhere to quality system requirements, including FDA 21 CFR Part 820 and ISO 13485.
• Prepare and review design change documentation, risk analyses (per ISO 14971), and verification/validation test reports.
• Support regulatory submissions, audits, and inspections by providing technical documentation and justifications.
• Track and report sustaining engineering metrics such as cost savings, issue closure rate, and product reliability performance
• Track project milestones, manage risks, and implement mitigation strategies.
• Ensure timely execution of verification, validation, and transfer to manufacturing activities.
• Provide guidance on materials, component selection, and system architecture.
• Oversee post-market product support, including design changes, component obsolescence, and supplier transitions.

Skills/Experience Required:

• 5+ years of engineering experience in the medical device industry.
• 3+ years of experience managing or leading engineering teams.
• Demonstrated experience with sustaining or product support engineering for Class II or Class III medical devices.
• Strong knowledge of FDA QSR, ISO 13485, ISO 14971, and related regulatory frameworks.
• Proficiency in design and development tools.
• Proven understanding of design controls, change management, and risk management.
• Proven ability to work successfully in a deadline driven environment with a sense of urgency.
• Bachelor's degree in Mechanical, Biomedical, Electrical, or Manufacturing Engineering (Master's preferred).

Sarnova is an Equal Opportunity Employer. We offer a competitive salary, commensurate with experience, along with a comprehensive benefits package, including 401(k) Plan. EEO/M/F/Veterans/Disabled. Our mission is to be the best partner for those who save and improve patients' lives. Excellence in delivering upon our mission is dependent upon having a diverse team that is empowered to bring their full, authentic self to work each day. We strive to create a workplace that reflects the communities we serve, and we are passionate about creating an inclusive workplace that promotes and values diversity.