Sustaining R&D Manager
Location
Waltham, MA
Level
Manager / Director
Department
MedTech
Type
Salary
$160,000 - $175,000
Job Description
Posted on:
2026-03-11
Responsibilities
- Oversee the technical lifecycle of existing Paragonix products and manage post-market design activities.
- Take ownership of the Design Transfer process for new product introductions.
- Lead root cause analyses for product non-conformances and manage corrective and preventive actions.
- Manage R&D activities for entering new international markets, ensuring compliance with global standards.
- Provide technical file support in collaboration with Quality and Regulatory Affairs teams.
- Monitor production data to identify trends and implement design improvements.
- Lead and mentor team members to achieve organizational goals and promote best practices.
Job Requirements
- Bachelor’s degree in Mechanical, Biomedical, or applicable engineering field (Master’s preferred).
- 8+ years of medical device development experience, with 3+ years in a managerial role.
- Experience with CAD/CAM tools (e.g., SolidWorks) and knowledge of GD&T principles.
- Expertise in failure mode and effects analysis (FMEA).
- Proficiency in statistical tools (e.g., Minitab, JMP) for data analysis.
- Familiarity with ISO 9001 and ISO 13485 standards, and cleanroom manufacturing processes.
- Six Sigma Green Belt or Black Belt is highly desirable.
