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Product Development Engineer

RevBio, Inc. Lowell, MA, USA

Compensation

$75,000 to $100,000 Annually

Benefits Offered

401K, Dental, Life, Medical, Vision

Employment Type

Full-Time

Why Work Here?

“A great opportunity for growth with an innovative company that is transforming how orthopaedic and dental procedures will be conducted”

Job Description:

The Product Development Engineer will actively interface with engineers, surgeons, and the executive management team to develop medical device products. This individual will develop concepts, drawings, and prototypes for new products and product platforms and will also work with vendors to build prototypes and/or testing models and may also interface with divisional R&D and product development resources as necessary.

Essential Duties and Responsibilities:

  • Support 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 communicate project plans, support team communications, perform activities and tasks as allocated, 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 and the intended uses;
  • Evaluate the performance and associated risks of such devices;
  • Interface with surgeons, customers, vendors, contractors, investors, and other internal and external constituents;
  • Support design of, and participate in, pre-clinical animal study evaluations along with cadaveric evaluations to attain design inputs, issue resolution, and final product evaluations;
  • Develop, write, and review Standard Operating Procedures (SOPs);
  • Prepare and support project design reviews;
  • Assist in the development and deployment of a Quality System;
  • Support the development of production processes;
  • Think creatively, problem solve, develop innovative solutions based on sound engineering skills and statistical analysis;
  • 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 1-3 years’ experience in product development (Medical Device Industry experience is preferred) or Bachelor’s Degree in Engineering and 2-5 years’ experience in product development;
  • Experience in product development; Medical Device Industry experience is preferred;
  • Experience with medical device mechanical, physical, and packaging test method development, characterization, and verification activities applicable to biomaterials along with applicable sterilization validation procedures;
  • Working knowledge of CAD systems (i.e. SolidWorks) experience is a plus;
  • Prior experience in the design of biomaterials highly desired;
  • Proficiency in understanding and application of design controls, development; and manufacturing processes, applying state of the art technologies, including statistics.

Specialized Knowledge and Skills:

  • The ability to lead multi-cultural, multi-discipline teams in developing medical products;
  • The ability to support project timelines independently or within a project team;
  • The ability to maintain design control documentation and project files and work within a budget;
  • The ability to develop and perform product testing to include mechanical and physical testing;
  • The internal motivation and ability to assist driving 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
RevBio, Inc.

About RevBio, Inc.:

RevBio, Inc., is a medical device company engaged in the development and commercialization of a patented, synthetic, injectable, self-setting, and osteoconductive bone adhesive biomaterial called Tetranite®. The company is initially developing this technology for use in the dental and cranial market. However, the company is also working to develop adhesive applications for the broader orthopaedics market and additional applications in the animal health market.

Company website: http://www.revbio.com

Company address: 600 Suffolk Street (c/o M2D2), Lowell, MA 01854

Posted date: 10 days ago

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