Sustaining R&D Manager

Getinge•Waltham, MA

13d•$160,000 - $175,000

About The Position

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.

Requirements

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.
Strong project management, communication and leadership skills

Nice To Haves

Six Sigma Green Belt or Black Belt is highly desirable.

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.
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.