Medical Device Engineer (Aseptic systems)

Medical Device Engineer (Aseptic systems)
BlueRock Therapeutics, Canada

Experience
1 Year
Salary
0 - 0
Job Type
Job Shift
Job Category
Traveling
No
Career Level
Telecommute
No
Qualification
As mentioned in job details
Total Vacancies
1 Job
Posted on
Mar 15, 2021
Last Date
Apr 15, 2021
Location(s)

Job Description

Who is BlueRock?

BlueRock Therapeutics, a wholly-owned and independently operated subsidiary of Bayer AG, is a leading engineered cell therapy company using its unique cell+gene platform to direct cellular differentiation and genetically engineer cells to create a new generation of cellular medicines that address large patient populations suffering from neurological, cardiovascular, and immunology diseases.

The convergence of cell biology and genetic engineering is creating fundamental new ways to impact disease. Founded in 2016 to capitalize on these technological breakthroughs, we are advancing our novel cell+gene platform to develop, manufacture, and deliver an entirely new generation of authentic and engineered cell therapies across three therapeutic areas: neurology, cardiology, and immunology.

What Are We Doing?

Our foundational science harnesses the ability to create and then direct the differentiation of universal pluripotent stem cells into authentic, functional cells that can be used as allogeneic cellular therapies to treat a broad array of diseases. We can also further engineer these cells, enabling them to produce enzymes, antibodies, and other proteins for additional therapeutic benefit.

We are passionate about delivering on the promise of cellular and gene therapy, shaping the future of cellular medicine, and delivering new therapies to millions of patients with treatment options.

We are seeking individuals who are collaborative, thrive in a fun and dynamic culture, and are steadfast in the commitment to advance cutting-edge cellular therapies to impact patients’ lives.

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.

Responsibilities:

  • 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 Ramp;D tools and equipment
  • Provide timely updates on tasks progress and day-to-day activities

Requirements

  • 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 Ramp;D (Candidates with more experience are encouraged to apply)
  • Experience with sterile handling of clinical solutions and reusable medical devices in operating rooms; preference fo

Job Specification

Job Rewards and Benefits

BlueRock Therapeutics

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