Senior Design Quality Engineer

Role: Senior Design Quality Engineer - Systems & Innovation

Contract: Via Randstad

Work Type: Hybrid (3 days per week onsite)

Your Role:

In this role, you have the opportunity to:

Drive Design Quality for innovation projects by shaping patient safety, product quality, and reliability early in development. In this senior role, you will execute our shift-left strategy across the V-model, influencing requirements, risk controls, verification, and design decisions to help teams prevent issues upstream and deliver safe, effective, and high-quality product releases.

You are responsible for:

• Lead Design Quality for multidisciplinary product and systems developments, ensuring quality is built in from concept through release. Drive shift-left quality by strengthening requirements, traceability, risk management, and verification strategies early in development.

• Guide teams on system decomposition, interfaces, integration risks, and design control deliverables so development decisions are robust, timely, and evidence based.

• Support reliability planning and execution activities, including accelerated testing, field-feedback-driven improvements, and reliability growth initiatives.

• Partner with R&D, Systems Engineering, V&V, Regulatory, and Operations to influence technical decisions and improve product safety, quality, and reliability.

• Support, challenge, and influence verification and validation strategies, driving statistically justified and risk-based approaches. Lead and coach structured risk management activities, including DFMEA and FTA, ensuring risk controls are translated into requirements and verified effectively.

• Use verification, validation, and post-market learning to strengthen design choices, release confidence, and continuous improvement.

Your Team:

You will join a high-impact Design Quality team supporting complex, multidisciplinary product and systems developments in a regulated environment. We are looking for a senior quality leader who can influence early design decisions, challenge constructively, and help teams embed proactive quality practices that improve patient safety, product quality, and innovation outcomes.

To succeed in this role, you should have the following skills and experience:

• Bachelor’s degree in Engineering with 12+ years of relevant experience, or a Master’s degree with 8+ years of relevant experience, preferably in Systems Engineering, Reliability, Design Quality, or product development within the medical device, health technology, or another highly regulated industry.

• Proven ability to influence cross-functional stakeholders across R&D, Systems Engineering, V&V, Regulatory, and Operations to improve development quality and support sound design decisions.

• Strong experience in complex product development, ideally including multidisciplinary systems and software-enabled products, with the ability to engage early in the design process and drive proactive quality.

• Demonstrated experience with requirements quality, traceability, interfaces, integration, risk management, and risk-based verification and validation planning in a regulated environment.

• Preferably certified in Design for Six Sigma (DfSS) at Green Belt level, with willingness to develop further towards Black Belt certification.

• Strong experience in structured problem solving, root cause analysis, and risk-based decision-making, using methods such as 8D, DMAIC, DFMEA, FTA, or similar.

• Good understanding of medical device regulations, standards, and design control expectations, such as 21 CFR 820, ISO 13485, EU MDR, IEC 60601, IEC 62366, IEC 62304, and ISO 14971.

• Strong interpersonal, written, and verbal communication skills, with the credibility to challenge constructively, coach teams, and influence senior stakeholders.