Engineering Manager: Verification Testing for Medical Devices at Medtronic in Boxborough, Massachusetts, United States of America

Job description

• 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.
• Engineering Manager, Test Engineering will own the full end-to-end verification work for large capital hardware/software medical device. Inclusive of hardware, software, and integration testing. Lead a team of test engineers.
• Lead a group of test engineers working on design verification for the Platforms and Solutions portfolio of products (capital systems, clinical software applications, and associated surgical instruments) within the Cranial and Spinal Technologies (CST) operating unit.
• At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary.

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.

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.
• Required Knowledge and 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.
• Requires a Baccalaureate degree (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) and minimum of 5 years relevant experience, or advanced degree with a minimum of 3 years prior relevant experience.
• 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.
• 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.

Skills

Required

• Test automation frameworks
• System integration testing
• Leadership and team management
• Mentoring and coaching
• Cross-functional collaboration

Preferred

• LabVIEW and TestComplete
• x-ray or medical imaging system testing
• IEC 60601-1 and IEC 60601-1-2 standards

Benefits

• 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. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
• Salary ranges for U.S (excl. PR) locations (USD):$142,400.00 - $213,600.00
• This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).
• The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).
• The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).
• The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).
• Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.
• Medtronic benefits and compensation plans