Medical Device R&D Project Lead

RevBio, Inc.; Lowell (MA); On-site; USD 110,000 - 160,000; Full time

Job summary

RevBio, Inc. in Lowell, MA seeks an experienced R&D Project Manager to guide medical device development from concept through prototyping and verification.

You will interface with engineers, surgeons, and leadership to develop project plans, budgets, and schedules while mitigating risks and tracking progress. You will lead design controls, contribute to regulatory filings (IDE, 510(k), PMA), develop test protocols, work with suppliers for prototypes, and ensure design inputs meet user needs.

Qualifications

• Degree in Engineering (Mechanical, Chemical or Biomedical preferred).
• Master’s Degree in Engineering with 3–5 years of product development experience or Bachelor’s Degree with 5–7 years of experience.
• 3+ years in leadership roles in project management; PMP certification is a plus.
• 5+ years of product development experience in the medical device industry preferred.
• Working knowledge of CAD systems (SolidWorks and Inventor), and prior FEA experience is desirable.
• Prior experience in biomaterials design is highly desired.
• Understanding and applying design controls in development projects; knowledge of Six Sigma is a plus.
• Strong manufacturing process knowledge using state-of-the-art technologies and process improvement techniques.

Responsibilities

• Lead medical device product development following FDA Design Controls 820.30 and applicable standards.
• Develop and coordinate regulatory submissions (IDE, 510(k), De Novo, PMA).
• Develop and communicate project plans, manage teams, drive activities, and promote collaboration.
• Develop design specifications from user needs via market research and VOC.
• Develop prototypes and test protocols that meet standards for intended uses.
• Evaluate performance risks of products under development.
• Interface with surgeons, customers, suppliers, contractors, investors, and colleagues.
• Lead design reviews and contribute to pre-clinical evaluations to obtain design inputs and resolve issues.

Skills

Leadership

Project management

Risk management

Design controls

Regulatory knowledge

Cross-functional collaboration

Communication

Statistical analysis

Manufacturing process understanding

Problem solving

Education

Bachelor's degree in Engineering

Master’s degree in Engineering

PMP certification

Tools

SolidWorks

Inventor

FEA

Job description

RevBio, Inc. in Lowell, MA seeks an experienced R&D Project Manager to guide medical device development from concept through prototyping and verification.

You will interface with engineers, surgeons, and leadership to develop project plans, budgets, and schedules while mitigating risks and tracking progress. You will lead design controls, contribute to regulatory filings (IDE, 510(k), PMA), develop test protocols, work with suppliers for prototypes, and ensure design inputs meet user needs.