Description of Position:
As part of BlueRock Therapeutics vision to change the future of medicine by enabling ground-breaking cell therapies, the Medical Device Engineer will be a key technical contributor to a dynamic and progressive team in the development of devices to facilitate delivery of cell therapy products. Programs focused on cardiac, neural and autoimmune diseases require development of point-of-use cell therapy preparation systems and interfaces to delivery technologies ranging from endovascular to stereotactic surgery. Medical Device Engineer will be a key participant involved in all aspects of medical device development including concept, design, prototyping, testing and manufacturing transfer. This role will also be involved in regulatory approval and patent filing activities. The ideal candidate will be a highly motivated individual with hands-on experience who enjoys having broad responsibilities and opportunities. Collaboration with a highly motivated, world-class team of scientists and engineers promises an exciting and engaging work environment for motivated, self-starting candidates. Familiarity with aseptic device systems, aseptic techniques and operating room procedures is a must.
- Assist in the design of cell+gene therapy point-of-use cell preparation and delivery systems
- Define medical device and system requirements, develop concepts, model (CAD), prototype and test
- Work closely with and manage development and manufacturing partners/suppliers, including CDMO’s, CMO’s and CRO’s
- Develop and manage project plans for complex medical devices and device systems
- Create engineering documentation (dwg, specs, BOMs, MIs, inspection forms, etc.)
- Develop verification and validation protocols, execute tests, perform analyses and write reports
- Prepare content for and support regulatory filings to various government bodies
- Support the development of intellectual property – invent new technologies, write invention disclosures, aid in preparation of patent filings
- Support pre-clinical and clinical research activities
- Work effectively in cross-functional teams with colleagues in a wide range of areas including cell biology, manufacturing (in-house and third party), quality, regulatory affairs, clinical development, surgery and interventional medicine
- Collaborate closely with Supply Chain, Quality, and Operations to ensure smooth flow of daily work
- Execute/oversee pilot manufacturing operations when needed
- Identify, specify and support implementation of R&D tools and equipment
- Provide timely updates on tasks progress and day-to-day activities
- Biomedical or Mechanical Engineering degree, or relevant Engineering degree with complementary work experience
- Minimum of 5+ years of experience in medical device development with a focus on R&D (Candidates with more experience are encouraged to apply)
- Experience with sterile handling of clinical solutions and reusable medical devices in operating rooms; preference for candidates with experience handling biological/cell materials
- Demonstrated experience developing aseptic clinical systems that protect against particulate, microbial and liquid contamination.
- Molded medical component design and production including connectors, valves, syringes, syringes, stopcocks, clamps, ports and needles desired.
- Experience in electromechanical machine design and manufacturing.
- Understanding of thawing and formulating cell based products.
- Knowledge in compounding sterile products in compliance with USP Chapter 797, preference for candidates who have demonstrated aseptic manipulation skills.
- Knowledge of design control systems such as ISO 13485 and FDA Quality System Regulation
- Experience with drafting Design Control documentation per ISO 13485 and the QSR
- Working knowledge of MS Office product suite
- Working knowledge of SolidWorks or other 3D CAD software.