Principal R&D Engineer - Peripheral Interventions

Working with cross-functional team members, you will develop strategies for aligning quality systems while maintaining product and business continuity. Technical Leadership: Lead and direct project teams, ensuring successful execution of technical work related to product design and development. Create a culture of high expectations, accountability, strong engineering fundamentals. Strategy, Design and Development: Gather and analyze requirements from internal and external stakeholders to capture user needs and translate them into actionable MedTech device product designs and development Problem-Solving and Compliance: Lead investigations into failure modes and perform root cause analyses to address technical challenges. Ensure compliance with relevant regulatory requirements and standards throughout the product lifecycle. Cross-Functional Collaboration: Engage in discussions with cross-functional and cross-team stakeholders to drive results and execute activities efficiently. Develop and maintain strong relationships with internal stakeholders, healthcare professionals, and suppliers. Documentation and Reporting: Present project updates, technical insights, and strategic recommendations to senior management. Review engineering documentation, including technical reports, DHF (Design History File), and DMR (Device Master Record), ensuring adherence to quality systems and policies. BS or above in Mechanical Engineering, Biomedical Engineering, or related field. 8+ years of engineering experience with a bachelor's degree OR 6+ years with a master's degree. 3+ years of experience with Medtech device design and development. Previous experience with product integrations Expertise to provide technical leadership with product strategy - design and development. Strong skills in collaborative stakeholder management, clear decision making, and project management expertise. Personal drive, individual accountability & a strong bias for action An independent critical thinker; willingness to challenge status quo Comfortable working ‘in the gray'; known for innovative, out of the box thinking to identify new approaches to meeting requirements Experience with medical device development for single use devices and those containing Electronic Medical Equipment Previous experience with lasers, fiber optics, acoustics preferred