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Director, Device Development at BlueRock Therapeutics - ApplyBlast

Director, Device Development

BlueRock Therapeutics

5 months ago

Remote

Full Time

Senior

0 applicants

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About this role

Director, Device Development at BlueRock Therapeutics, leading the design, development, and commercialization of combination medical devices and ancillary products for cell therapy portfolio.

Responsibilities

Acts as technical representative on project teams for complex delivery and preparation device systems, spanning system, device, and component levels.
Defines and maintains technical strategy, design intent, and risk profile across development phases, from early development through clinical phases and handoff to those with ownership for launch and commercial sustainment.
Provides expert judgment on material selection, key quality target product profile, usability, manufacturability, and design trade-offs, particularly for cell therapy combination products (drug delivery, dose preparation, accessories, etc.).
Leads cross-functional collaboration across Device Development, TDT, Quality, Regulatory, Supply Chain, Commercial and Bayer stakeholders.
Serves as primary escalation point for device-related technical and executional issues, resolving ambiguity and enabling timely decision-making.

Skills

Qualifications

Bachelor’s or Master’s degree or equivalent, or PhD with 10+ years of experienceB.S. or M.S. in Biomedical, Materials engineering, or related and a minimum of ten years of medical product (preferably medical device or biologics) development and manufacturing experienceThorough 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 technologiesDemonstrated cross functional leader with successful track record of delivering projects on time and within budget