SummaryThe Principal Engineer, Technology Development leads the development and commercialization of advanced materials and products across CQ Medical's technology portfolio, with the majority of work supporting Radiation Therapy applications. This role translates research and laboratory concepts into reliable, manufacturable, and regulatory-compliant medical products, with particular depth in polymer and thermoplastic materials development.
The position works across R&D, manufacturing, quality, regulatory, and commercial teams to bring new technologies to market, and partners closely with Dan, as a peer, on thermoplastic materials initiatives.
Key Duties and Responsibilities (Other duties may be assigned.)Materials & Product Development:
- Lead development of materials, processes, and products from concept through commercialization.
- Translate laboratory research into scalable manufacturing processes and production-ready products.
- Evaluate and optimize material performance, manufacturability, reliability, and cost.
- Develop material specifications, manufacturing requirements, and test methods.
- Engage external polymer chemist consultants and material suppliers to support thermoplastic materials development.
Regulatory, Quality & Intellectual Property:
- Support design verification, validation, risk analysis, and regulatory compliance activities, including alignment with FDA design control and quality system requirements (21 CFR Part 820).
- Collaborate with IP counsel on invention disclosures, patent applications, and freedom-to-operate assessments for new materials and technologies.
Cross-Functional Collaboration:
- Collaborate with multidisciplinary teams including engineering, quality, operations, suppliers, and external partners.
- Partner with Dan and the Technology Development team, as a peer, on thermoplastic materials initiatives supporting both Radiation Therapy and IWS product lines.
Continuous Improvement & Customer Support:
- Provide technical leadership for product improvements, troubleshooting, and continuous improvement initiatives.
- Support customer, clinical, and market feedback activities to guide product development.
Required Education, Experience and CertificationsEducation: Master's degree in Engineering, Materials Science, Polymer Science, Chemistry, Physics, or a related technical field, or equivalent experience.
Experience: 10+ years of experience in product development, materials engineering, manufacturing engineering, medical devices, or related industries. Demonstrated experience with polymer and thermoplastic materials is required. Additional experience in three or more of the following is expected: materials characterization and testing; medical device development; radiation therapy, diagnostic imaging, or healthcare technologies; manufacturing process development and scale-up; extrusion, molding, coating, lamination, or additive manufacturing; design controls, risk management, and regulated product development; failure analysis and root-cause investigation; or engineering simulation and analysis tools.
Knowledge, Skills and Abilities- Demonstrated depth in polymer and thermoplastic materials, with the ability to bridge research and development with manufacturing and commercialization.
- Strong technical problem-solving and project leadership skills.
- Effective communicator capable of working with scientific, engineering, quality, and business teams.
- Self-directed with the ability to lead multiple projects in a fast-paced environment.
- Working knowledge of FDA design control and quality system requirements (21 CFR Part 820).
- Experience collaborating with IP counsel on invention disclosures and patent strategy.
