Product Development Manager- Medical Device

Clear Dynamic is revolutionizing pain management through glass microsphere technology. Our proprietary, water-soluble embolic particles provide targeted treatments for patients. Developed using advanced materials engineering, our microspheres are designed to safely dissolve in the body, providing a precise and innovative approach to pain intervention. We are a passionate team, dedicated to improving patient outcomes through groundbreaking materials science. Join us as we shape the future of interventional medicine.

**About the Opportunity**

As Product Development Manager you will be responsible for establishing and leading end-to-end product development processes, starting with a novel embolization device and expanding to future interventional or therapeutic technologies. This is a hands-on role, requiring active technical and project leadership across all stages of development. You will develop the product development framework and ensure that all designs are safe, manufacturable, compliant, and aligned with regulatory requirements. A core responsibility is to implement and maintain robust design control procedures in accordance with ISO 13485 and 21 CFR Part 820. The role includes managing both internal and external design engineering resources, engaging with suppliers and test partners, and contributing to the strategic evolution of the product portfolio - delivering technically sound, commercially viable, and regulatory-compliant medical devices.

**Key Responsibilities**
- Serve as the product development process owner, establishing and maintaining procedures to ensure alignment with applicable regulations and standards.
- Maintain awareness of the competitive landscape, emerging technologies, and relevant clinical practices to inform and guide product design strategy.
- Plan, lead, and execute product development projects from concept through design transfer and commercialization.
- Ensure all design activities are conducted under robust design control procedures compliant with ISO 13485 and 21 CFR Part 820.
- Serve as the technical lead and ensure the safety, performance, and manufacturability of all design outputs.
- Lead the development of risk management documentation (e.g., Hazard Analysis, dFMEAs, pFMEas, etc.) by collaborating with cross-functional internal and external stakeholders.
- Lead / co-lead or actively participate in design reviews to ensure technical soundness, design control compliance, risk mitigation, and cross-functional alignment at all key development milestones.
- Act as the interface with external design and test partners, ensuring clear technical requirements and accountability.
- Coordinate cross-functional input from quality, regulatory, clinical, and commercial stakeholders to align development with business strategy.
- Prepare or review and approve high-quality design documentation, including Design History Files (DHF) and risk management documentation.
- Actively participate in the change process to ensure the proposed changes to the products are systemically and thoroughly analyzed and assessed.
- Ensure appropriate training on product development processes and design control requirements.
- Participate in or otherwise support regulatory submissions with required technical documentation.
- Lead or support technical investigations into product quality issues, including root cause analysis and implementation of corrective and preventive actions, in collaboration with Quality and other cross-functional teams.
- Recommend improvements to quality systems, processes, and product risk mitigations, as appropriate.
- Perform other related duties as assigned to support the successful execution of product development and organizational objectives, as required.

**About You**

We would love to hear from you if you have the following
- Bachelor's degree in Engineering, Biomedical Engineering, or related field.
- 3+ years of experience in product development, engineering, or regulated environment with 2 years in a leadership or technical management role highly preferred.
- Strong working knowledge of ISO 13485, 21 CFR Part 820, ISO 14971 and design control principles.
- Experience with risk management tools and methodologies (e.g., FMEA, Hazard Analysis).
- Demonstrated experience effectively managing suppliers.
- Proven ability to develop technically sound, manufacturable, and regulatory-compliant design solutions.
- Excellent communication and project management skills; PMP certification is a plus.
- Demonstrated ability to adapt to changing priorities, manage ambiguity, and thrive in a fast-paced, evolving startup environment.
- High attention to detail with strong emphasis on traceability and completeness.
- Ability to manage multiple responsibilities in a matrixed environment, where accountability is shared between functional (Quality, Product Development, Regulatory) and project (Program, Core Team) leadership.
- Strong engineering, analytical, interpersonal, and problem-sol