Lowell, Massachusetts, United States · On-site
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 mit…
Skills: Project Management, Medical Device Development, FDA Design Controls 820.30, CAD (SolidWorks, Inventor), Finite Element Analysis (FEA)
Lowell, Massachusetts, United States · Hybrid
Job Description: The Clinical Research Associate will support the execution and oversight of clinical studies across multiple indications and geographic regions, including the United States, Europe, and the United Kingdo…
Skills: Clinical Site Management, Good Clinical Practice (GCP), Clinical Trial Monitoring, Regulatory Documentation, Electronic Data Capture (EDC)
Lowell, Massachusetts, United States · Hybrid
Job Description: The Clinical Research Manager will lead and support clinical operations across multiple indications and geographic regions, including the United States, Europe, and the United Kingdom. This individual wi…
Skills: Clinical Operations Management, Site Relationship Management, CRO Oversight, Regulatory Compliance, Clinical Trial Planning
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The R&D Project Manager leads the development of medical devices by coordinating project plans, budgets, and cross-functional teams. They are responsible for creating prototypes, managing regulatory submissions, and ensuring compliance with FDA design controls.
Candidates must have an Engineering degree with 5-7 years of product development experience or a Master's with 3-5 years, preferably in the medical device industry. Proficiency in CAD systems and experience in leadership roles or PMP certification are highly desired.
Transforming Bone Repair
The standard of care for healing broken bones hasn't changed in over fifty years. Invasive metal hardware is still routinely used to fixate bones–often with less-than-optimal patient outcomes. RevBio® is a medical device company that has invented TETRANITE®, a regenerative bone adhesive currently in 150 patients across seven FDA approved clinical trials. Our patented “bone glue” is founded upon a comprehensive patent portfolio with global patent protection extending through 2042. Easily injectable into a range of musculoskeletal defects, TETRANITE has demonstrated superior performance over other standard of care options in curing speed and strength, rate of resorption, bone regeneration, and most critically wet-field adhesion. As a novel technology, TETRANITE is anticipated to receive a De Novo classification for several indications which will expedite the path to commercialization by Q3 2027. Bioengineered for a body of applications, the TETRANITE platform will address a total addressable market of over $10 billion in neurosurgical, orthopaedic and dental use cases.Inspired by the marine animal the sandcastle worm, Tetranite is simple chemistry. Bioengineered from the worm’s secreted protein, our synthetic adhesive is the only patented biomaterial which satisfies both the required and desired properties for a bone adhesive: wet field performance, multi-surface bonding, rapid mechanical stability, and controlled biodegradability. The properties of Tetranite™ include the ability to provide immediate fixation of bone to bone and bone to metal. This adhesive has been shown in multiple animal studies to be a non-toxic and effective way of repairing bone fractures and defects as well as securing implant devices. Existing data has also shown that Tetranite™ is reabsorbed and replaced with new bone during the natural process of bone remodeling by acting as a scaffold to facilitate bone growth over time.
Offices: 600 Suffolk Street, Suite 250, Lowell, MA 01854, US
Transforming Bone Repair
The standard of care for healing broken bones hasn't changed in over fifty years. Invasive metal hardware is still routinely used to fixate bones–often with less-than-optimal patient outcomes. RevBio® is a medical device company that has invented TETRANITE®, a regenerative bone adhesive currently in 150 patients across seven FDA approved clinical trials. Our patented “bone glue” is founded upon a comprehensive patent portfolio with global patent protection extending through 2042. Easily injectable into a range of musculoskeletal defects, TETRANITE has demonstrated superior performance over other standard of care options in curing speed and strength, rate of resorption, bone regeneration, and most critically wet-field adhesion. As a novel technology, TETRANITE is anticipated to receive a De Novo classification for several indications which will expedite the path to commercialization by Q3 2027. Bioengineered for a body of applications, the TETRANITE platform will address a total addressable market of over $10 billion in neurosurgical, orthopaedic and dental use cases.Inspired by the marine animal the sandcastle worm, Tetranite is simple chemistry. Bioengineered from the worm’s secreted protein, our synthetic adhesive is the only patented biomaterial which satisfies both the required and desired properties for a bone adhesive: wet field performance, multi-surface bonding, rapid mechanical stability, and controlled biodegradability. The properties of Tetranite™ include the ability to provide immediate fixation of bone to bone and bone to metal. This adhesive has been shown in multiple animal studies to be a non-toxic and effective way of repairing bone fractures and defects as well as securing implant devices. Existing data has also shown that Tetranite™ is reabsorbed and replaced with new bone during the natural process of bone remodeling by acting as a scaffold to facilitate bone growth over time.
Offices: 600 Suffolk Street, Suite 250, Lowell, MA 01854, US