Senior Director, Technical Development Lead, Device

Responsibilities:

• Strategy & Leadership
• Define and lead the medical device development strategy aligned with the company’s cell therapy pipeline and long‐term platform vision.
• Act as a core leader for combination product development, ensuring strategic alignment across various technical areas.
• Serve as the primary technical leader in governance forums.
• Act as a thought leader in device‐enabled cell therapy delivery, monitoring emerging technologies, standards, and competitive approaches.
• Produce Development Oversight
• Lead integration of device options into an overall program strategy
• In partnership with functional leadership, oversee device development activities including but not restricted to: user needs, design inputs/outputs, risk management, verification & validation, and design transfer
• Ensure device designs are compatible with sterile, GMP, and scalable manufacturing environments while meeting international or region-specific standards.
• Program Leadership
• Drive integrated development plans and timelines ensuring execution across a matrixed organization
• Partner with Regulatory Affairs to define and execute U.S. and global regulatory strategies for combination products (e.g., FDA CDRH/CBER interactions).
• Support regulatory submissions including IND‐enabling device sections, IDEs, 510(k), PMA, De Novo, and combination product filings as applicable.
• Partner with various stakeholders to ensure devices meet real‐world clinical workflows and adoption requirements
• Ensure compliance with ISO 13485, ISO 14971, 21 CFR Part 820, and applicable combination product regulations.
• Minimum Requirements:
• Advanced degree (MS, Ph.D., or equivalent) in Biomedical Engineering, Mechanical Engineering, Materials Science, or related discipline.
• 12+ years of progressive experience in medical device development, with senior leadership experience in biotech, medtech, or combination product environments.
• Demonstrated success leading complex device programs from concept through commercialization.
• Hands‐on experience with combination products, drug‐device or biologic‐device integrations strongly preferred.
• Deep knowledge of medical device regulatory frameworks and design control requirements.
• Track record of building and leading high‐impact technical teams.
• Experience managing external development partners, CDMOs, and device vendors.
• Strategic thinker with strong execution discipline
• Collaborative, strategic leader who thrives in cross‐functional matrix organizations
• Clear communicator with the ability to influence at executive and board levels
• Equal Opportunity Workplace: At BlueRock, we welcome and support differences and diversity and we are proud to be an equal opportunity workplace. Please let us know if you require disability-related accommodation or other grounds protected by human rights legislation during the recruitment process so that we can work with you to meet your needs.
• We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.