Hardware Systems Lead
MedTechPharmaRegulatory AffairsQuality Assuranceheoremacroinform
Job description
We anticipate the application window for this opening will close on - 26 Sep 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life This role supports the development of medical device systems spanning disposables, capital equipment, wearable technologies, short-term implantable products, and associated software platforms. The Hardware Systems Lead serves as the technical integrator across electrical hardware, radio frequency (RF) communications, embedded firmware, mechanical design, and software interfaces to deliver system-level solutions that meet product performance, manufacturability, quality, cost, and regulatory requirements. This position may be based onsite in either Santa Clara, California or Lafayette, Colorado. The role requires close collaboration with cross-functional engineering, quality, regulatory, and manufacturing teams throughout the product development lifecycle. The Hardware Systems Lead provides system-level technical leadership for new product development programs and sustains engineering activities. This position oversees architecture definition, subsystem integration, technical tradeoff analysis, and cross-functional coordination to ensure successful delivery of complex medical device systems. The role works closely with hardware, firmware, software, mechanical, manufacturing, quality, and regulatory teams to align product requirements with technical execution. Primary Responsibilities Define and maintain product system architecture across electronics, embedded firmware, mechanical subsystems, RF communications, and software interfaces. Translate user, product, and business requirements into system and subsystem specifications while balancing technical, schedule, and cost constraints. Lead technical tradeoff analyses involving power consumption, RF performance, component selection, manufacturability, reliability, and product cost. Coordinate development activities across printed circuit board (PCB), firmware, antenna, enclosure, and subsystem integration efforts. Partner with software engineering teams to establish feature requirements, interface definitions, integration strategies, and verification plans. Drive system integration activities and resolve complex cross-functional technical issues throughout the product development lifecycle. Lead design reviews, risk management activities, verification planning, and validation readiness assessments. Collaborate with manufacturing, quality, and regulatory teams to support design for manufacturability and compliance with applicable medical device requirements. Required Qualifications Bachelor's degree and 7+ years of relevant engineering experience, or an advanced degree and 5+ years of relevant engineering experience. Experience defining system architectures for complex electromechanical and embedded hardware products. Experience leading cross-functional technical integration efforts involving hardware, firmware, mechanical, and software development teams. Experience performing system-level verification, validation, and technical risk management activities. Ability to translate product requirements into subsystem specifications and system design decisions. Preferred Qualifications Bachelor's or advanced degree in Electrical Engineering. Experience with embedded electronics design and system integration. Experience with RF design considerations, wireless communications, and antenna integration. Experience leading new product development programs within a regulated industry. Experience supporting design for manufacturability and product commercialization activities. For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required. Physical Job Requirements The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. U.S. Work Authorization & Sponsorship At Medtronic, we are committed to fostering an environment where employees can thrive and make a meaningful impact. In alignment with our enterprise-wide workforce planning approach, U.S. work authorization sponsorship (H-1B, TN, J, etc.) is offered exclusively for Principal-level roles and above, where specialized expertise aligns with long-term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment. Recruitment Fraud Alert We are aware of phishing scams targeting job seekers. Please keep the following in mind: Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses. Medtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Any such requests are not legitimate. If you receive a suspicious message claiming to be from Medtronic, do not respond, click links, or open attachments. If you have any questions, concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic, please contact us immediately at AskHR@medtronic.com . Benefits & Compensation Medtronic offers a competitive Salary and flexible Benefits Package A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create.
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