Engineering Manager: Hardware Testing for Medical Devices

Medtronic•Boxborough, MA

8d•$142,400 - $213,600•Onsite

About The Position

Medtronic is seeking an Engineering Manager, Test Engineering to lead end-to-end verification for large capital hardware/software medical devices, encompassing hardware, software, and integration testing. This role involves leading a team of test engineers within the Cranial & Spinal Technologies (CST) operating unit, which focuses on advancing care for neurological and spinal conditions through innovative surgical imaging and navigation solutions. The manager will be responsible for design verification for platforms and solutions, including capital systems, clinical software applications, and surgical instruments. The company emphasizes a collaborative, in-person work environment, requiring a minimum of 4 days a week onsite. Medtronic is committed to bringing bold ideas forward to improve patient outcomes and foster professional growth.

Requirements

Requires a Baccalaureate degree in Mechanical Engineering, Electrical Engineering, Computer Science, Biomedical Engineering, or a related engineering discipline (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A)).
A minimum of 5 years of relevant experience, or an advanced degree with a minimum of 3 years of prior relevant experience.
Requires practical knowledge in leading and managing the execution of processes, projects and tactics within one job area.
Typically has advanced knowledge and skills within a specific technical or professional discipline with understanding of the impact of work on other areas of the organization.
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.

Nice To Haves

Experience developing or testing Software as a Medical Device (SaMD) or software within a medical device context.
Experience with test automation frameworks, specifically LabVIEW and TestComplete.
Hands-on experience with system integration testing of complex hardware/software systems.
Familiarity with x-ray or medical imaging system testing.
Working knowledge of IEC 60601-1 and IEC 60601-1-2 electrical safety and electromagnetic compatibility standards.
Experience with reliability demonstration of large capital equipment.
Experience mentoring, developing, and growing peers and/or direct reports.
Demonstrated ability to influence and lead cross-functional teams.
Practical knowledge of leading and managing the execution of engineering processes, projects, and tactics across software, hardware, or test engineering.
Experience testing across a range of product types including embedded/firmware, capital equipment, or connected systems.

Responsibilities

Plans, directs, and implements all aspects of the test strategy, design, and execution for hardware and software components of a large capital equipment imaging system (O-arm), including Software as a Medical Device (SaMD).
Leads and manages a team of test engineers across design verification, test automation, and system integration testing activities.
Owns and is accountable for on-time delivery of test milestones across multiple concurrent projects and releases throughout the product development lifecycle.
Drives the development and adoption of test automation frameworks to improve test efficiency, coverage, and repeatability.
Guides the conceptualization of new test methodologies, automation strategies, and approaches to verifying product behavior, which may span virtual environments, physical labs, or both.
Directs the development of test plans, protocols, and verification strategies from initial design through release, ensuring alignment with applicable regulatory, cybersecurity, privacy, and quality system requirements (e.g., FDA, IEC 62304, ISO 13485, ISO 14971, HIPAA, GDPR, SOC 2, as relevant to the product).
Leads system integration testing activities, ensuring hardware and software components function correctly as an integrated imaging system.
Selects, develops, coaches, and evaluates personnel to ensure efficient operation of the test function and the growth of technical talent within the team.
Influences and collaborates with cross-functional teams including systems engineering, software engineering, hardware engineering, regulatory affairs, and quality.
Provides technical leadership and mentorship to test engineers at all levels.