R&D Project Manager

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

The R&D Project Manager will actively interface with engineers, surgeons, and the company’s executive management team to develop project plans and associated budgets, lead project teams, identify and mitigate risks, and track and report progress on assigned projects. This individual will develop concepts, drawings, and prototypes for new products, and will also work with suppliers to build prototypes and/or test models, and may also interface with other company personnel and product development resources as necessary.

Essential Duties and Responsibilities

• Lead the product development of medical devices following the appropriate standards as per Federal Drug Administration’s Design Controls 820.30 and appropriate international standards;
• Develop and coordinate files and content for regulatory submissions (e.g., IDE, 510(k), De Novo, PMA, etc.);
• Develop and communicate project plans, manage team communications, drive activities and task allocations, and promote team collaboration;
• Develop and establish design specifications based on user needs through market research activities such as voice of customer interviews and surveys;
• Develop prototypes and test protocols that conform to the applicable standards based on the intended uses of the products under development;
• Evaluate the performance and associated risks of products under development;
• Interface with surgeons, customers, suppliers, contractors, investors, and other internal and external constituents;
• Lead the design of, and participate in, pre-clinical animal and cadaveric evaluations to attain design inputs, resolve issues, and conduct final product evaluations;
• Develop, write, and review Standard Operating Procedures (SOPs);
• Prepare and lead project design reviews;
• Assist in the maintenance and enhancement of the company’s quality system;
• Support the development of production processes;
• Think creatively, problem solve, and develop innovative solutions based on sound engineering skills and statistical analyses;
• Travel to customers, vendors, and other locations (required 10-20%), including potential international locations; and
• Perform other tasks as may be required from time to time.

Essential Education, Skills, Environment Education and Work Experience

• Degree in Engineering (Mechanical, Chemical or Biomedical preferred);
• Master’s Degree in and 3-5 years’ experience in product development (Medical Device Industry experience is preferred) or Bachelor’s Degree in Engineering and 5-7 years’ experience in product development;
• 3+ years of leadership roles in project management, Project Management Professional (PMP) certification a plus;
• 5+ years of product development experience, preferably in the medical device industry;
• Working knowledge of CAD systems (SolidWorks and Inventor), and preferably prior FEA experience;
• Prior experience in the design of biomaterials highly desired;
• Proficiency in understanding and applying of design controls, and their development;
• A strong understanding of manufacturing processes using state of the art technologies; and process improvement techniques (Six Sigma Green or Black Belt preferred).

Specialized Knowledge and Skills

• The ability to lead multi-cultural, multi-discipline teams in developing medical products;
• The ability to develop and effectively manage project timelines independently or within a project team;
• The ability to maintain design control documentation, budgets, and project files;
• The ability to develop and perform product testing to include mechanical and physical testing and finite element analysis;
• The internal motivation and ability to personally drive a project and gain support from various required resources from within and outside of the company;
• The ability to build positive relationships inside and outside the Company, and to effectively communicate project status that might affect related research and development work for other programs; and
• The willingness to do assist in all necessary areas to achieve success.

We are an equal opportunity employer and all qualified applicants will receiveconsideration for employment without regard to race, color, religion, sex,national origin, disability status, protected veteran status, or any othercharacteristic protected by law.