The Manager, Systems Test Engineering provides technical and people, leadership for a team responsible for system-level testing of complex medical devices across the Cardiovascular and Ultrasound businesses. This leader is accountable for developing and advancing systems test engineering capabilities spanning design verification, validation, reliability engineering, test methods, fixtures, tools, automation, and test infrastructure.
The role serves as a knowledgeable systems engineering test mentor and partners closely with Software, Hardware, Quality, Regulatory, Clinical, Manufacturing, and Program Management. The Manager will establish test strategies and engineering practices that improve product quality, reliability, development efficiency, and confidence in product performance while ensuring compliance with applicable design controls, standards, and regulatory requirements.
Primary Duties and Responsibilities:Functional/Technical Leadership:- Provide technical knowledge for Systems Test Engineering across new product development, sustaining engineering, and product improvement initiatives.
- Contribute to the development of system test and design verification strategies for complex medical devices, including hardware, software, firmware, electromechanical, and integrated system functionality.
- Provide technical guidance in requirements-based testing, design verification, validation support, test method development, test fixtures, automated testing, data acquisition, test tools, and test infrastructure.
- Support verification approaches provide objective evidence that products meet system and subsystem requirements, intended performance, and applicable regulatory and quality requirements.
- Support risk-based test strategies that connect product requirements, architecture, use cases, risk management, verification, and reliability.
- Contribute to technical oversight of test protocols, methods, fixtures, equipment qualification, test method validation, data analysis, traceability, and verification reports.
- Contribute to automation and modern test engineering practices to improve test coverage, repeatability, efficiency, data quality, and speed of product development.
- Contribute to discussions around reliability engineering principles throughout product development, including reliability planning, reliability demonstration testing, accelerated life testing, environmental/stress testing, statistical analysis, failure analysis, and reliability growth.
- Contribute to technical direction for investigation of complex system failures and product performance issues, ensuring effective root-cause analysis and implementation of appropriate corrective actions.
- Partner with Systems, Hardware, Software, Quality, Regulatory, Clinical, and Manufacturing Engineering to ensure robust product architectures and testable requirements.
- Contribute to technical discussions during design reviews, risk reviews, verification readiness reviews, and other product development milestones.
- Support continuous improvement of engineering procedures, standards, tools, laboratory capabilities, and best practices while maintaining compliance with the Quality Management System and applicable medical device regulations and standards.
People Leadership:- Coach, and develop Systems Test Engineers, building both technical depth and leadership capability.
- Contribute to discussions around expectations, priorities, accountability, and performance objectives aligned with product development and business needs.
- Support the team's technical capabilities in system verification, validation, reliability, automation, test method development, fixtures, tools, data analysis, and medical device product development.
- Support understanding of current and future organizational capabilities and contribute to talent and staffing plans to address business and technology needs.
- Provide ongoing coaching, technical mentorship, performance feedback, and career development for team members.
- Support the creation of individual development and succession plans and identify opportunities for engineers to expand technical expertise and leadership responsibilities.
- Support a culture of engineering rigor, technical curiosity, collaboration, accountability, continuous improvement, and patient-focused quality.
- Attract, select, onboard, and retain engineering talent and build a diverse team with the capabilities required to support the product portfolio.
- Balance project execution with longer-term capability development, ensuring engineers have opportunities to build expertise while meeting program commitments.
- Encourage effective collaboration and knowledge sharing across engineering disciplines, business units, sites, and external partners.
Planning and Strategy Leadership:- Contribute to the technical and product development strategy for the Cardiovascular and Ultrasound businesses by representing system verification, validation, reliability, and product quality perspectives.
- Partner with R&D and business leadership and contribute to development of product roadmaps and technology strategies into Systems Test Engineering capability, resource, laboratory, and technology plans.
- Contribute to the development of multi-year roadmaps for test engineering capabilities, including automation, test platforms, fixtures, simulation, data analytics, reliability engineering, laboratory infrastructure, and emerging test technologies.
- Support resource, capacity, and competency plans that support multiple concurrent product development and sustaining programs.
- Partner with program and functional leadership on project planning, schedules, technical risks, resource allocation, and trade-off decisions.
- Identify opportunities to standardize and reuse test methods, automation frameworks, fixtures, tools, and infrastructure across product platforms and business areas.
- Contribute to development of meaningful metrics to assess verification effectiveness, test coverage, automation, reliability, quality, engineering efficiency, and organizational capability.
- Maintain awareness of emerging technologies, industry practices, regulatory expectations, and applicable standards and contribute to incorporating relevant advancements into the organization's test engineering strategy.
- Represent Systems Test Engineering in cross-functional leadership forums and contribute to decisions that improve product quality, reliability, time to market, and long-term business performance.
Supervisory Responsibility:
- This refers to direct line control over a group of staff members in recruiting and selection, compensation and promotion, performance appraisal, budgetary control and termination.
Qualifications (Knowledge, Skills & Abilities)Minimum- Bachelor's degree in biomedical engineering or related technology field
- 3 - 5 years of experience in product and technology development
- 1 - 2 years of experience leading technical teams.
- 5+ years' experience in the medical device industry or highly regulated industry
- Experience with developing and retaining technical talent
- Ability to lead people and achieve results through others as demonstrated by a clear record of accomplishments
- Experience working across the full product development lifecycle, from concept and requirements through verification, design transfer, launch, and sustaining engineering.
- Experience working in a matrix environment
- Demonstrated ability to deliver on time, on budget in a fast-paced lean environment
- Contribute to communications designed to interface, negotiate and influence multi-disciplinary teams and with different levels of personnel
- Intrinsically curious, innovative thinker and problem solver.
Preferred- Advanced degree in biomedical engineering or related technology field
- Background in reliability engineering, including reliability planning, reliability prediction/modeling, accelerated life testing, reliability demonstration testing, Weibull or other statistical reliability analysis, and reliability growth.
- Experience developing automated system test architectures, simulation environments, test frameworks, or advanced test/data infrastructure.
- Experience with cardiovascular, diagnostic or interventional medical devices and/or ultrasound imaging systems.
- Knowledge of applicable standards such as IEC 60601, IEC 62304, IEC 62366, and other standards relevant to cardiovascular and/or ultrasound medical devices.
Other - Adheres to all company policies, procedures and business ethics codes and ensures that they are communicated and implemented within the team.
- Ability to travel domestically up to 20% of the time. Occasional international travel.
Compensation & Total Rewards:Estimated Beginning Salary: $160,000.00 - $175,000.00*Estimated salary is intended to reflect the salary Bracco Medical Technologies reasonably expects to pay for the position. The provided range is based on salary and market data and may vary based on an employee's eligibility for geographic differential pay in high-cost-of-labor markets.
Total Rewards:- Paid Time Off, Company Holidays & Paid Family Leave - We provide PTO and Company Holidays to help you recharge, relax and do what's important to you, when it's important to you. Our 100% paid family leave options for parents, grandparents and eligible family members provide support for growing families as well.
- Achieve - Beyond competitive compensation, we offer options to help you plan for a financially secure future, including an annual incentive plan and 401k savings plan contributions.
- Live well - We offer comprehensive benefit options to help protect you along the way, including medical, dental, vision, and life insurance, employer HSA contributions, employee assistance program, short-term disability, etc.
- Evolve - Through structured on-the-job learning, workshops, seminars, and our tuition reimbursement program, you'll find many opportunities to grow, personally and professionally.
- Choose -You won't find "stuffy" here whether your position requires a hybrid or in-the-office working arrangement. That means business casual for your attire and flexibility in your schedule, wherever possible.
