Senior Manager, Hardware Engineer, OLYSENSE

Working Location: Massachusetts, Westborough Workplace Flexibility: Hybrid For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling. ​ ​ ​ Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives. ​ Our five Core Values empower us to achieve Our Purpose: Patient Focus, Integrity, Innovation, Impact and Empathy. Learn more about Life at Olympus: . Job Description The Senior Hardware Engineering Manager, OLYSENSE Hub Platform leads the hardware engineering section responsible for evaluating, integrating, qualifying, sustaining, and evolving commercial off-the-shelf (COTS) computing platforms used as regulated medical device hardware platforms. The role is accountable for delivery of high-quality technical work packages across technology development, product development, production transfer, post-market engineering, and lifecycle management activities. The Senior Hardware Engineering Manager, OLYSENSE Hub Platform shall ensure state-of-the-art technical excellence in medical-grade computing platform architecture, systems integration, supplier and OEM management, reliability engineering, hardware qualification, and lifecycle sustainment. Unlike a traditional electronics design leadership role, this position emphasizes hardware platform architecture, COTS platform integration, supplier management, reliability, manufacturability, serviceability, and cross-functional execution rather than custom PCB or circuit board design. The role combines people leadership with senior technical leadership and is expected to operate at the intersection of functional management, platform ownership, and hands-on technical problem solving This position will report directly to the Director, Software Engineering Edge and will represent the hardware engineering function for the OLYSENSE Hub platform within the broader SCC Platform engineering organization. The role is accountable for building, mentoring, and maintaining a highly capable hardware platform and systems integration engineering team of approximately 5 to 6 engineers, while ensuring that assigned technical work packages are delivered on target with respect to quality, timing, cost, manufacturability, reliability, compliance, serviceability, and patient safety. The Senior Hardware Engineering Manager, OLYSENSE Hub Platform is accountable to define and maintain the long-term hardware platform roadmap supporting cloud-connected and on-premises AI-enabled medical device applications. This includes technology refresh planning, component obsolescence mitigation, end-of-life strategies, supplier and OEM alignment, reliability improvement, lifecycle cost optimization, resource and budget planning, and alignment of hardware platform decisions with software, AI, systems, operations, quality, and regulatory priorities. Job Duties Lead hardware engineering strategy and planning for the OLYSENSE Hub platform, including budget, capacity, resources, infrastructure, laboratory capabilities, external engineering support, prototype builds, test equipment, suppliers, and production transfer needs. Build, lead, mentor, and develop the Hardware Platform and Systems Integration Engineering team , ensuring effective resource utilization, technical capability development, performance management, and alignment with Olympus business and product objectives. Provide technical leadership and accountability for hardware engineering deliverables, including architecture, component selection, interface specifications, verification inputs, test plans, design documentation, manufacturing transfer, lifecycle records, and technical contributions to the Design History File. Own the OLYSENSE Hub hardware platform roadmap and lifecycle strategy , including technology refresh, scalability, component obsolescence, alternate sourcing, end-of-life planning, platform consolidation, upgrades, and long-term platform sustainability. Lead cross-functional product development, production transfer, and lifecycle sustainment , partnering with Software, AI, Systems Engineering, Product Management, Quality, Regulatory, Operations, Purchasing, Suppliers, Contract Manufacturers, Service, and external laboratories to ensure product readiness, compatibility, reliability, manufacturability, and serviceability. Drive hardware reliability and continuous improvement , using field performance, failure data, manufacturing metrics, supplier performance, customer feedback, complaints, CAPA, post-market surveillance, and service data to address issues, reduce service burden, and improve platform robustness. Lead post-market investigations, engineering changes, product enhancements, and sustaining activities. Define and maintain electrical safety and EMC compliance strategy for the OLYSENSE Hub platform, applying applicable standards including IEC 60601-1, IEC 60601-1-2, IEC 62368-1:2023, and regional requirements. Coordinate external laboratory testing, test configurations, acceptance criteria, issue resolution, and supporting technical documentation. Develop hardware engineering capabilities, infrastructure, and external partnerships , including laboratory and test capabilities, prototype configuration management, supplier/OEM relationships, contract manufacturing interfaces, external engineering partners, and test laboratories required to support development, qualification, production, troubleshooting, and lifecycle management. Ensure execution within the Olympus Quality Management System and drive engineering efficiency , including compliance with design control and change management requirements and standardization of components, interfaces, design reviews, test planning, supplier engagement, lifecycle documentation, and technical decision-making. Job Qualifications Required: Bachelor’s degree in Electrical Engineering, Computer Engineering, Systems Engineering, Computer Science, Biomedical Engineering, Medical Engineering, or a related technical discipline required. Master’s degree in Biomedical Engineering, Computer Engineering, Electrical Engineering, Systems Engineering, or a related technical discipline preferred. Minimum of 10 years of experience in hardware engineering, embedded/industrial PC platforms, COTS computing, medical electrical equipment, or comparable regulated hardware development. Minimum of 5 years of engineering leadership or people management, including technical leadership, resource planning, mentoring, performance management, and talent development. Strong experience integrating COTS/embedded computing platforms into production products, including CPUs/GPUs, motherboards, PCIe, storage, networking, peripherals, video interfaces, firmware/drivers, and Windows-based environments. Experience supporting the full medical device lifecycle, from concept through commercialization, production, and post-market/sustaining engineering, within design control and QMS requirements. Experience with electrical safety and EMC compliance, including IEC 60601-1, IEC 60601-1-2, IEC 62368-1, CISPR 32, and coordination with external test laboratories. Strong experience troubleshooting complex hardware issues involving thermal performance, power, signal integrity, EMC, electrical safety, reliability, video paths, software/driver interactions, manufacturing quality, suppliers, and field performance. Hardware Architecture & Systems Integration: Ability to architect, integrate, qualify, and sustain COTS medical-grade computing platforms using requirements, interfaces, standards, design controls, and risk-based engineering. Embedded Computing & Hardware/Software Integration: Strong understanding of embedded/industrial PC architectures, Windows IoT/Windows-based systems, GPUs, capture/video interfaces, storage, networking, peripherals, firmware, drivers, and configuration management. Manufacturing & Supplier Management: Ability to lead design transfer, production readiness, manufacturing scale-up, configuration control, supplier/OEM/CM relationships, and resolution of quality and supply-chain issues. Technical Judgment & Decision Making: Ability to balance patient safety, quality, regulatory compliance, performance, cost, manufacturability, supply chain, serviceability, software compatibility, and lifecycle considerations. Cross-Functional Leadership & Communication: Ability to lead and align Software, AI, Systems Engineering, Quality, Regulatory, Manufacturing, Purchasing, Service, suppliers, OEMs, contract manufacturers, and external laboratories. Communicate complex technical issues effectively to technical and non-technical audiences. Resource Planning & Execution: Ability to prioritize work, manage capacity and budget inputs, plan engineering infrastructure and external support, identify bottlenecks, manage escalations, and execute effectively under schedule, supplier, technical, quality, and regulatory constraints. People Development & Technical Ownership: Ability to mentor engineers, build technical capability, establish clear ownership, and continuously improve engineering practices, documentation, test strategies, supplier engagement, and technical decision-making. Why join Olympus? We offer a holistic employee experience supporting personal and professional well-being through meaningful work, equitable offerings, and a connected culture. Equitable Offerings you can count on: Competitive salaries, annual bonus and 401(k)* with company match Comprehensive medical, dental, vision coverage effective on start date 24/7 Employee Assistance Program Free live and on-demand Wellbeing Programs Generous Paid Vacation and Sick Time Paid Parental Leave and Adoption Assistance* 12 Paid Holidays On-Site Child Daycare, Café, Fitness Center** Connected Culture you can embrace: Work-life integrated culture that supports an employee centric mindset Offers onsite, hybrid and field work environments Paid volunteering and charitable donation/match programs Employee Resource Groups Dedicated Training Resources and Learning & Development Programs Paid Educational Assistance *US Only **Center Valley, PA and Westborough, MA Are you ready to be a part of our team? Learn more about our benefits and incentives: . The anticipated base pay range for this full-time position in this location is $137,657.00 - $192,722.00 / year, plus potential for annual bonus (subject to plan eligibility and other requirements). Olympus considers a variety of factors when determining actual compensation for this position, including level of experience, working location, and relevant education and certifications. At Olympus, we are committed to Our Purpose of making people’s lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states. For more than 100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world. Headquartered in Tokyo, Japan, Olympus employs more than 31,000 employees worldwide in nearly 40 countries and regions. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,200 employees throughout locations in North and South America. For more information, visit . You Belong at Olympus We are deeply committed to fostering a respectful, fair, and welcoming workplace for all individuals, perspectives, and lifestyles. We believe in fostering a non-discriminatory, inclusive work environment where everyone feels a sense of belonging, in full compliance with legal standards. Empathy and unity are core to our company culture, empowering employees to contribute fully and flourish. We warmly encourage all who wish to bring their talents to Olympus to apply. Applicants Requesting Accommodations: Olympus is committed to the full inclusion of all qualified individuals. As part of this commitment, Olympus will ensure that persons with disabilities are provided reasonable accommodations for the hiring process. If reasonable accommodation is needed, please contact . If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (1-888-659-6787). Let’s realize your potential, together. It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law. Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Research and Development