• Understand the scope of projects to implement automated test scripts; • Design automation strategies, defining priority scenarios for test coverage; • Develop and maintain automated functional and component test scripts; • Continuously evolve the automation, increasing test coverage each sprint; • Reuse automation code and components to improve efficiency and standardization; • Ensure continuous execution of tests in DevOps pipelines; • Support squads in anticipating risks and identifying issues during the development cycle; • Validate acceptance criteria before development begins; • Execute tests in parallel with development, contributing to higher-quality deliveries; • Identify gaps, impacts on integrated systems, and possible scope changes; • Perform corrective and evolutionary maintenance of automation; • Generate reports and metrics on automation coverage; • Collaborate with developers, QAs, and other squad members to ensure continuous quality in deliveries.

• Develop and maintain automated tests for new feature functionality within the sprint. • Build and expand automated regression test suites to ensure stability of existing features. • Define, estimate, prioritize, and coordinate testing activities within the scrum team. • Contribute to and enhance internally built test automation frameworks. • Design scalable and maintainable test strategies for UI, API, and integration testing. • Identify, log, and track defects, ensuring clear and actionable bug reports. • Collaborate closely with developers, product managers, and DevOps to ensure shift-left testing practices. • Analyze failures across distributed systems, including logs, traces, and service interactions. • Ensure quality across end-to-end POS workflows, including offline/online scenarios and edge cases. • Support and improve CI/CD pipelines, ensuring automated tests are integrated into release workflows. • Mentor and guide QA engineers, fostering a culture of automation and quality ownership.

• Develop and execute comprehensive test plans, test cases, and test scripts • Perform functional, integration, regression, and performance testing • Validate data migration from legacy systems • Collaborate with developers and stakeholders to design test strategies • Identify, document, and track defects using tools like Jira • Participate in Agile ceremonies for quality assurance insights • Support user acceptance testing (UAT) and validate training materials • Create and maintain QA documentation for gate reviews

Role Description As a Sr. Engineer, Design Quality, you will be responsible for ensuring that product design, development, and lifecycle changes meet all applicable quality and regulatory requirements across Getinge’s Infection Control Consumables portfolio. This includes FDA Class I and II medical devices, EU MDR Class I devices, and selected non-regulated products. You will serve as a core quality leader within cross-functional teams, providing design assurance oversight and driving compliance across the full product lifecycle. This includes ownership of design control execution, risk management activities, and change governance within the Arena PLM system. You will act as a subject matter expert (SME) in design quality, influencing decision-making, ensuring inspection readiness, and driving adherence to internal procedures and external standards including FDA 21 CFR 820/QMSR, ISO 13485, ISO 14971, and EU MDR. Qualifications - Demonstrated leadership, problem-solving, decision-making, influencing, facilitation, and communication skills. - Deep knowledge of applicable quality and regulatory standards, including FDA 21 CFR 820/QMSR, ISO 13485, ISO 14971, and EU MDR 2017/745. - Strong expertise in design control, risk management, and product lifecycle management. - Proven ability to lead cross-functional team discussions and influence decision-making without direct authority. - Advanced analytical and problem-solving skills, including root cause analysis and risk-based decision making. - Strong technical writing and documentation review skills with high attention to detail. - Experience with statistical methods, sampling plans, and data analysis. - Experience supporting design changes across the product lifecycle and working within PLM systems (Arena preferred). - Ability to work effectively in a fast-paced, cross-functional, and highly regulated environment. - Excellent interpersonal skills, with the ability to develop collaborative relationships across teams and functions. Requirements - Bachelor’s degree in science, engineering, or other technical areas; or equivalent job experience required. Advanced degree preferred. - 5+ years of relevant experience in the medical device industry; and have several years of experience in Design Quality, Quality Engineering, or a related role within the medical device industry. - Applied knowledge of ISO 13485:2016, ISO 14971:2019, 21 CFR 820 QSMR, and EU Medical Device Regulation 2017/745 (MDR). - Working knowledge of international standards and regulations applicable to medical devices and combination products. - Familiarity with Geometric Dimensioning and Tolerancing (GD&T) standards and principles. - Experience supporting design changes across the product lifecycle, hands-on experience with a PLM system (Arena preferred). - Ability to apply practical and technical problem solving to quality system and product improvements. - Excellent interpersonal skills, including ability to work effectively cross-culturally and cross-functionally. - Proven ability to effectively lead cross-functional team meetings. - Capable of developing matrix relationships with key colleagues in other functional areas and divisions. - Champions high quality deliverables, innovation, and appropriate risk-based decision making. - Ability to understand the sensitivity within Getinge’s environment. - Excellent project management and interpersonal skills. - Adaptable to changes in work environment. - Ability to work in a fast-paced environment. - The position is remote, with 25% travel as needed. Benefits - Health, Dental, and Vision insurance benefits - 401k plan with company match - Paid Time Off - Wellness initiative & Health Assistance Resources - Life Insurance - Short and Long Term Disability Benefits - Health and Dependent Care Flexible Spending Accounts - Commuter Benefits - Parental and Caregiver Leave - Tuition Reimbursement