Senior Design Quality Engineer [F/M/X] – Amaris Consulting – 's-Hertogenbosch

Jobid=4c78b4729ba0 (0.0992)

Job description

We are seeking a technically strong Senior Engineer with deep expertise in quality, systems engineering and electrical hardware development to support a strategic project for a global leader in health technology. This role bridges quality assurance and engineering excellence, ensuring that complex medical systems are designed and delivered with the highest levels of safety, reliability, and performance.

You will act as a key quality partner within multidisciplinary R&D teams, focusing on the integration of quality principles into the design of advanced electronic systems and subsystems. Your technical background in electrical hardware and systems will enable you to critically assess designs, drive robust verification strategies, and ensure compliance throughout the product lifecycle.

Key Responsibilities

• Lead the development and execution of Design Quality and Reliability strategies for high-complexity medical systems, with a focus on electrical, electronic, and hardware components.
• Apply systems engineering principles to ensure end-to-end traceability from user needs and regulatory requirements to hardware design inputs, verification, and validation.
• Define and oversee Quality and Reliability Plans that cover system architecture, PCB design, signal integrity, power management, EMI/EMC, and environmental robustness.
• Provide technical quality oversight during electrical hardware design reviews, ensuring adherence to best practices in circuit design, component selection, and failure mode mitigation.
• Lead and support FMEA (Design and Process) activities with a strong focus on electrical and system-level risks, ensuring effective control plans are implemented.
• Collaborate with R&D teams to validate critical design inputs such as performance, safety, reliability, and usability—using statistical methods and test plans tailored to hardware development.
• Ensure robust verification and validation of electrical systems, including environmental testing, long-term reliability (MTBF), and compliance with standards such as IEC 60601, IEC 61010, and IEC 62366.
• Analyze development and field failure data to identify root causes in hardware performance and drive corrective actions and design improvements.
• Champion Design for Excellence (DfX) principles—such as DfR (Design for Reliability), DfT (Design for Testability), and DfM (Design for Manufacturability)—within electrical and system design processes.
• Ensure completeness and compliance of Design History Files (DHF) and Device Master Records (DMR), with particular attention to hardware documentation, schematics, BOMs, and test reports.
• Serve as a technical quality advisor to engineering teams, providing guidance on Design Controls, risk management (ISO 14971), and regulatory requirements (ISO 13485, 21 CFR Part 820, EU MDR).
• Work closely with post-market and service teams to close the loop between field performance and next-generation design improvements.

Ideal Candidate Profile

• Bachelor’s or Master’s degree in Electrical Engineering, Systems Engineering, Electronics, or a related technical discipline.
• 12+ years of experience with a Bachelor’s degree or 8+ years with a Master’s in Design Quality, Reliability, or R&D Engineering, preferably in medical devices, aerospace, industrial systems, or high-reliability electronics.
• Strong hands-on background in electrical hardware design and development
• DfSS (Design for Six Sigma) Green Belt certified; progression toward Black Belt is a plus.
• Experience with root cause analysis of hardware failures using techniques such as 5-Why, Fishbone, and Fault Tree Analysis.
• Familiarity with hardware test automation, data acquisition systems, and instrumentation used in validation environments.
• Solid knowledge of medical device regulations and standards, including ISO 13485, IEC 60601 series, IEC 62366, and ISO 14971.
• Proficient in quality tools and processes: CAPA, Change Control, Risk Management, Design Reviews, and Verification & Validation.
• Excellent communication and collaboration skills, with the ability to work effectively in multidisciplinary, agile R&D environments.
• Willingness to work onsite at least 3 days per week (based in the Netherlands).

Personal Attributes

• Technically curious and passionate about engineering excellence.
• Analytical, detail-oriented, and committed to delivering robust, safe, and reliable systems.
• Proactive problem-solver with a hands-on mentality and a drive for continuous improvement.
• Strong communicator who can translate technical risks into business impact.
• Team player with the ability to influence without authority and mentor cross-functional teams.

Why This Role Matters

You will play a pivotal role in ensuring that cutting-edge medical systems are not only innovative but also engineered to the highest standards of quality and safety. Your expertise in electrical hardware and systems will directly contribute to product reliability, regulatory success, and improved patient outcomes.