Key Responsibilities:

• Strategic Leadership & Business Development

  • Lead and manage cross-functional engineering team in the design, development, and commercialization of IsoQore platform

  • Develop and implement engineering strategies aligned with company goals and product roadmaps

  • Provide technical leadership in the innovation and optimization of IsoQore V. 1.0

  • Develop and execute on a partnering strategy to likely include one or more collaborators over time

• Product Development & Innovation

  • Oversee all stages of product development, from concept design to regulatory approval and potential commercialization

  • Ensure platform meet technical, functional, safety, and regulatory requirements

  • Foster innovation by identifying emerging trends, new technologies, and opportunities for product improvement

• Regulatory & Compliance Oversight

  • Ensure compliance with medical device regulations (e.g., FDA, ISO, CE Mark) throughout the development process

  • Interface with regulatory bodies during audits, submissions, and reviews to ensure product safety and compliance

  • Oversee risk management activities, including hazard analysis, FMEAs (Failure Modes and Effects Analysis), and risk assessments.

• Team Management & Development

  • Recruit, mentor, and develop engineering talent, fostering a culture of collaboration and innovation

  • Set performance goals, conduct reviews, and provide guidance to ensure team members are meeting expectations

  • Build and maintain a collaborative relationship with cross-functional teams (R&D, manufacturing, regulatory affairs)

• Project Management

  • Lead multiple engineering projects, ensuring they are completed on time, within scope, and within budget

  • Manage resource allocation, timelines, and deliverables for engineering projects

  • Collaborate with stakeholders across departments to ensure alignment and execution

• Budget & Resource Management

  • Develop and manage budgets, ensuring effective use of resources and cost efficiency

  • Evaluate and seek approval for investments in new technologies, equipment, and partnerships to drive innovation and efficiency

• Quality & Process Improvement

  • Implement best practices in design controls, quality management systems, and continuous improvement processes

  • Ensure high-quality standards are maintained throughout product development and production

You should have:

• Bachelor’s or master’s degree in engineering (Biomedical, Mechanical, or related field). An M.B.A. or Ph.D. is a plus

• At least, 15 years of experience in medical device or instrument development, with at least 5 years in a leadership role

• Basic understanding of engineering and instrument design and manufacturing techniques

• In-depth knowledge of FDA regulations, ISO standards, and other global medical device regulatory requirements

• Significant business development and collaboration experience, with a preference for a senior/leadership role, with a track record of successful deal execution

• Proficiency in CAD software, design verification/validation processes, and risk management methodologies

• Strong attention to detail, organizational and record keeping skills.

• Proven experience in managing engineering teams, driving performance, and fostering innovation

• Excellent communication, and interpersonal skills and the ability to effectively present complex data to diverse audiences.

• Comfortable operating in a fast-paced start-up environment, with strong desire to learn and contribute to the advancement of our IsoQore cell isolation platform.

What we offer:

Compensation: A competitive salary in addition to equity.

Benefits: Health, Dental, and Vision insurance, FHA, 401(k), commuter benefits

At cTRL Therapeutics, we embrace the different backgrounds, perspectives, and experiences our team members bring to the table. As a proud Equal Opportunity Employer, we welcome all applicants and teammates regardless of race, color, ancestry, national origin, religion or religious creed, mental or physical disability, medical condition, genetic information, sex (including pregnancy, childbirth, and related medical conditions), sexual orientation, gender identity, gender expression, age, marital status, military or veteran status, citizenship, or other characteristics protected by applicable law. If you need assistance or an accommodation due to a disability, please contact us.

To apply for the Head of Platform Engineering position, please submit your resume to HR@ctrl-tx.com