Sustaining R&D Manager

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.

Paragonix Technologies Job Description/Posting -Sustaining R&D Manager

The Sustaining R&D Manager serves as the technical lead of Paragonix's commercialized portfolio, balancing rigorous engineering oversight with strategic growth initiatives. In this role, you will strive for seamless transition of new product introductions (NPI) from design to contract manufacturing, ensuring all devices are optimized for scalability, cost-efficiency, and regulatory compliance. You are the primary technical lead for post-market excellence, driving structured root cause investigations for field complaints and non-conformances, while proactively managing the Design History File (DHF) and Risk Management activities. Beyond maintenance, you will spearhead R&D efforts to adapt our technologies for market expansion and execute value-engineering projects focused on business objectives, ensuring our life-saving organ preservation solutions remain best-in-class throughout their entire lifecycle.

Primary Responsibilities

• Oversee the technical lifecycle of the existing Paragonix products by serving as the primary point of contact for all post-market design activities. Ensure all related initiatives are effectively managed and brought to successful completion.
• Take ownership of the Design Transfer process for NPI, ensuring the Device Master Record (DMR) is fully prepared and available for manufacturing operations.
• Lead thorough root cause analyses to address product non-conformances, defects, and field complaints. Lead corrective and preventive action (CAPA) efforts to resolve identified issues and prevent recurrence.
• Manage R&D technical activities required for entering new international markets, ensuring strict compliance with relevant global standards.
• Provide comprehensive technical file support by working closely with the Quality and Regulatory Affairs teams.
• Monitor production and post-market data to identify trends in product performance. Initiate and implement design improvements as needed to enhance overall reliability and quality.
• Lead and mentor team members to achieve organizational goals by providing ongoing guidance, coaching, and professional development opportunities. Promote and reinforce best practices across the organization.

Qualifications

• Bachelor's degree in Mechanical, Biomedical, or other applicable engineering field (Master's preferred).

• 8+ years of medical device development experience. 3+ years managing direct reports.
• Experience with CAD/CAM tools (e.g., SolidWorks) and familiarity with GD&T principles.
• Expertise in failure mode and effects analysis (FMEA).
• Proficiency in statistical tools (e.g., Minitab, JMP) and the ability to analyze complex data sets to identify trends.
• Familiarity with ISO 9001 and ISO 13485 standards, as well as experience with cleanroom manufacturing or sterilization processes.
• Six Sigma Green Belt or Black Belt is highly desirable.
• Strong project management, communication and leadership skills

General Responsibilities

• Clearly communicate technical challenges and risks across all levels of the organization to promote transparency and informed decision-making, while proactively identifying and addressing issues by implementing practical solutions that maintain product quality and reliability.

• Utilize interpersonal skills to communicate, advise, negotiate, and influence stakeholders, while building productive relationships across departments and external partners.
• Demonstrate strong problem-solving and decision-making capabilities to resolve complex engineering and production challenges.
• Exhibit self-motivation and strategic thinking skills, with the ability to tackle intricate problems and drive continuous improvement initiatives.
• Travel may be required for approximately 15% of the time.

#LI-YA2 #LI-Onsite

Annual salary of 160K - 175K depending on expeirence with 10% STIP

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.