via Indeed
$130K - 287K a year
Developing complex electro-mechanical medical devices with hardware, software, and AI/ML features, leading multidisciplinary teams, and managing product lifecycle from concept to launch.
Minimum 10 years of product development experience in a regulated industry, with 4+ years of people management, and familiarity with medical device standards and regulatory requirements.
At Stryker’s Inari Medical, we are transforming the lives of patients suffering from venous and other vascular diseases through purpose-driven innovation. As a fast-growing medical device company, we develop breakthrough technologies that treat life-threatening conditions with speed, safety, and precision. Join us in shaping the future of vascular health. We are currently seeking a Senior R&D Manager to join our team of passionate innovators and engineers. As the Senior R&D Manager, you will oversee the development, engagement, and collaboration of your 3-5 direct reports, as well as work closely with the product/project team. Know more about the Division Here: Inari Medical You will need to live within commuting distance to our 6001 Oak Canyon STE 100, Irvine, CA office. You will need to be in the office 5 days a week. What You Will Do • Provide technical and strategic leadership for the development of complex electro-mechanical medical devices from concept through commercialization. • Lead and mentor a multidisciplinary R&D team across mechanical, electrical, software, and systems engineering, fostering innovation and technical excellence. • Define and manage system-level requirements, integrating hardware, embedded software, and AI/ML-driven features to enhance device performance and clinical value. • Oversee design, prototyping, feasibility testing, and risk management to ensure compliance with design controls, software lifecycle standards (e.g., IEC 62304), and cybersecurity requirements. • Partner cross-functionally with Quality, Regulatory, and Manufacturing to ensure smooth design transfer, manufacturability, and successful regulatory submissions. • Drive technology development and intellectual property generation to support future business and customer needs. • Manage project resources, budgets, and timelines while communicating progress and outcomes to senior leadership and key stakeholders. • Promote a culture of innovation, collaboration, and professional growth through performance coaching, talent development, and cross-functional knowledge sharing. What You Need Required Qualifications • Bachelor of Science in Engineering or related discipline • Minimum 10 years of product development experience in engineering, quality, regulatory, or manufacturing engineering within a highly regulated industry (automotive, pharma, aerospace), • 4+ years of people management experience Preferred Qualifications • Experience in the medical device industry with a strong understanding of full product lifecycle management from concept through launch. • Proven expertise in developing complex electro-mechanical medical devices integrating hardware, software/firmware, and precision components. • Working knowledge of AI/ML applications, digital health integration, and cybersecurity within regulated medical environments. • Familiarity with key regulatory and quality standards, including ISO 13485, IEC 62304, ISO 14971, and FDA 21 CFR Part 820. • Demonstrated leadership, problem-solving, and communication skills with the ability to drive cross-functional collaboration and design transfer to manufacturing. $129,600 - $286,500 salary plus bonus eligible + benefits. Individual pay is based on skills, experience, and other relevant factors.
This job posting was last updated on 12/11/2025