Senior Director, Device Development

7 days ago


Toronto, Ontario, Canada BlueRock Therapeutics Full time
About BlueRock Therapeutics

BlueRock Therapeutics 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.

Job Summary

We are seeking a Senior Director, Device Development to lead our device development and manufacturing activities in support of our product portfolio and programs. The successful candidate will provide leadership for device development and manufacturing activities, working closely with cross-functional peers and team members to influence and define product and clinical strategy.

Key Responsibilities
  • Provide leadership for device development and manufacturing activities in support of BRT product portfolio and programs.
  • Work in close collaboration with cross-functional peers and team members to influence and define product and clinical strategy.
  • Identify and assess new product and manufacturing technologies for possible integration and development.
  • Take a leadership role in medical and combination device product development efforts, including customer interactions and design controls.
  • Collaborate with engineers and cross-functional product development teams to develop leading-edge integrated cell therapy products.
  • Ensure all development complies with relevant regulatory standards and guidance, and company product development, manufacturing, and product quality requirements.
Requirements
  • Bachelor's or Master's degree or equivalent, or PhD with 12+ years of experience with a minimum of ten years of medical product (preferably medical device or biologics) development and manufacturing experience.
  • Experience with biologic product delivery is a strong plus.
  • Thorough understanding of Design Controls and cGMP requirements compliant with ISO 13485 and the QSR (21 CFR Part 820).
  • Significant experience in development and validation of medical device manufacturing processes and technologies is required.
  • Demonstrated cross-functional leader with successful track record of delivering projects on time and within budget.
What We Offer

We offer a dynamic and collaborative work environment, with opportunities for professional growth and development. If you are a motivated and experienced leader in medical device development, we encourage you to apply for this exciting opportunity.



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