Sr. Manager, R&D

Getinge; Boston (MA); On-site; USD 160,000 - 175,000; Full time

Job summary

Paragonix Technologies is seeking a Senior Manager, R&D - Thoracic New Product Development to lead multidisciplinary engineering teams from concept through commercialization, shaping product strategy and technology roadmaps for heart and lung preservation devices.

You will influence project direction, manage technical risk, ensure FDA design controls, ISO 13485/14971 compliance, and collaborate across Clinical, Regulatory, Quality, Marketing, Operations, and Manufacturing.

Qualifications

• Bachelor's in Mechanical or Biomedical engineering required; 10+ years of device development.
• 3+ years leading engineering teams or direct reports.
• Experience from concept through commercialization in medical devices.
• Strong understanding of design controls, risk management, and regulated development.

Responsibilities

• Lead new product development programs for thoracic preservation and transport technologies.
• Drive feasibility, design, verification, validation, and manufacturing transfer.
• Build and lead high-performing engineering teams, fostering innovation and accountability.
• Define technical strategy, product architecture, and roadmaps.
• Collaborate with Clinical, Regulatory, Quality, Marketing, Operations, and Manufacturing teams.
• Identify intellectual property opportunities and contribute to the innovation pipeline.

Skills

Strong communication

Leadership

Problem-solving

Education

Bachelor's degree in Mechanical/Biomedical Engineering

Master's degree in Engineering/Biomedical Engineering (preferred)

Tools

CAD tools (SolidWorks)

Injection molding

Medical device assembly

Job description

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.

This role is open to US based candidates

Paragonix Technologies develops organ preservation and transport technologies that help transplant teams protect donor organs during the journey from donor to recipient. Our portfolio supports cardiac, thoracic, abdominal, and multi-organ preservation and is focused on improving donor organ quality and transplant logistics. As we expand our thoracic portfolio, we are seeking a Senior Manager, R&D, to lead development of next-generation heart and lung preservation technologies with direct impact on patients, transplant centers, and organ procurement teams.

About the Opportunity

Reporting to the Senior Director of R&D, the Senior Manager, R&D - Thoracic New Product Development will lead multidisciplinary engineering teams responsible for developing innovative medical devices from concept through commercialization. This is a highly visible leadership role with direct influence on product strategy, technology roadmaps, intellectual property, and the future of thoracic organ preservation.

• Lead development of technologies that directlyimpacttransplant outcomes and help save lives.
• Shape the future of heart and lung preservation and transportation.
• Workalongside experts in engineering, transplantation, clinical care, and medical innovation.
• Influence product strategy, technology direction, and organizational growth.
• Join a fast-growing company where innovation, speed, execution, and accountability matter.

Primary responsibilities

• Lead new product development programs for thoracic preservation and transport technologies.
• Drive innovation from concept generation through feasibility, design, verification, validation, and manufacturing transfer.
• Build and lead high-performing engineering teams while fostering innovation, accountability, and technical excellence.
• Define technical strategy, product architecture, development priorities, and technology roadmaps.
• Partner with Clinical, Regulatory, Quality, Marketing, Operations, and Manufacturing teams to deliver successful products.
• Identifyintellectual property opportunities and contribute toParagonix'sinnovation pipeline.
• Manage technical risk and ensure compliance with FDA design control expectations, ISO 13485, and ISO 14971.

Required Qualifications

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or related engineering discipline.
• 10+ years of medical device product development experience.
• 3+ years leading engineering teams or direct reports.
• Proven success developing products from concept through commercialization.
• Strong understanding of design controls, risk management, and regulated product development.
• Experience with plastics, injection molding, medical device assembly, or related manufacturing processes.
• Experience with CAD tools; SolidWorks preferred.
• Strong communication, leadership, prioritization, and problem-solving skills.
• Experience developing Class II

Preferred Qualification

• Master's degree in Engineering, Biomedical Engineering, or related technical field.
• Experience developing Class III medical devices.
• Experience with electromechanical systems,monitoringtechnologies, disposables, or capital equipment.
• Experience in transplant, thoracic, cardiac, respiratory, perfusion, critical care, or adjacent healthcare technologies.
• Knowledge of IEC 62366, FDA human factors guidance, ISO 10993, and IEC 60601.
• Experience contributing to patents, invention disclosures, or technology strategy.

General responsibilities

• Onsite personnel
• Must be willing to travel 15%

US BASED SALARY - The minimum base salary for this position is $160,000 and the maximum salary is $175,000 plus 10% in annual bonus.

#LI-YA2 #LI-Onsite

About us

With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.

Benefits at Getinge

At Getinge, we offer a comprehensive benefits package, which includes:

• Health, Dental, and Vision insurance benefits
• 401k plan with company match
• Paid Time Off
• Wellness initiative & Health Assistance Resources
• Life Insurance
• Short and Long Term Disability Benefits
• Health and Dependent Care Flexible Spending Accounts
• Commuter Benefits
• Parental and Caregiver Leave
• Tuition Reimbursement

Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.