Sr. Engineer, Design Quality

Job Overview

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.

Job Responsibilities and Essential Duties:

• Serve as the Quality lead on design and development programs, ensuring robust implementation of design controls and compliance throughout the product lifecycle.
• Own and govern design control processes and deliverables, including design inputs/outputs, specifications, risk management documentation, and verification/validation activities, ensuring completeness, accuracy, and compliance with internal and external requirements.
• Provide expert guidance and make quality decisions regarding design and process changes, including assessment of regulatory impact, risk implications, and required verification and validation activities.
• Own risk management activities in accordance with ISO 14971, including development and maintenance of risk management plans, hazard analyses, and FMEAs, ensuring risks are appropriately identified, evaluated, and controlled.
• Establish and enforce traceability across design controls, ensuring clear linkage between user needs, design inputs, outputs, risk controls, and verification/validation evidence.
• Lead change management activities within the Arena PLM system, including review and approval of Engineering Change Orders (ECOs), ensuring technical rigor, regulatory compliance, and documentation integrity.
• Define and drive critical-to-quality (CTQ) requirements, ensuring alignment between design intent, product performance, and acceptance criteria across components, materials, and finished goods.
• Ensure robust verification and validation strategies are defined and executed, including review of protocols and reports to confirm alignment with design requirements and risk mitigation strategies.
• Act as a Quality subject matter expert (SME) in cross-functional discussions, influencing design decisions and ensuring risk-based, compliant outcomes across R&D, Regulatory Affairs, Manufacturing, and Operations.
• Support product classification and regulatory applicability assessments for FDA Class I and II medical devices, EU MDR Class I devices, and non-regulated products.
• Lead audit readiness efforts and support internal and external audits, ensuring documentation is inspection-ready and providing clear rationale and objective evidence for design and change decisions.
• Drive root cause investigations and CAPA activities, ensuring structured problem-solving, appropriate corrective actions, and verification of effectiveness.
• Mentor and provide technical guidance to junior engineers, promoting best practices in design quality, risk management, and regulatory compliance.
• Drive continuous improvement initiatives within design control, risk management, and change management processes to enhance efficiency, compliance, and product quality.
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Required Knowledge, Skills and Abilities:

• Demonstrated leadership, problem-solving, decision-making, influencing, facilitation, and communication skills, with the ability to engage effectively at all organizational levels.
• 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.

Minimum 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), and comfort working in a mixed portfolio environment that includes both regulated and non-regulated products.
• 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; Recognizes other colleagues' areas of expertise and utilizes them effectively to achieve team objectives.
• Champions high quality deliverables, innovation, and appropriate risk-based decision making.
• Ability to understand the sensitivity within the 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.

Quality Requirements: 

Build Quality into all aspects of their work by maintaining compliance to all quality requirements.

• Ensure compliance to all FDA and Worldwide Quality & Compliance regulations (As applicable to the job function).
• Must have the education and experience to understand and comply with U.S. and Worldwide medical device regulations (As applicable to your job function).
• Attend all required Quality & Compliance training at the specified interval.
• Adopt the “Beyond Compliance Quality Culture” in the work environment; always meet and exceed requirements.

Environmental/Safety/Physical Work Conditions: 

• Ensures environmental consciousness and safe practices are exhibited in decisions
• Use of computer and telephone equipment and other related office accessories/devices to complete assignments
• May work extended hours during peak business cycles
• This position is remote

The physical demands described here are a representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

$96,000-$120,000 + 4% STIP