Getinge logo
Getinge

With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.

Senior Engineer, Design Quality

QA EngineerQA EngineerFull TimeRemoteSeniorTeam 10,001

Location

Michigan

Posted

9 days ago

Salary

$96K - $120K / year

Seniority

Senior

BS

Job Description

Senior Engineer, Design Quality

Getinge

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

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