Senior Design Quality Engineer [F/M/X]

Senior Design Quality Engineer [F/M/X]

– Amaris Consulting Location: ’s‑Hertogenbosch, North Brabant, Netherlands About Amaris Consulting Amaris Consulting is an independent technology consulting firm that provides guidance and solutions to businesses worldwide. With more than 1,000 clients across the globe, we have been delivering solutions in major projects for over a decade. Our international team of 7,600 people operates across 5 continents and 60+ countries, focusing on Information System & Digital, Telecom, Life Sciences and Engineering. Recruitment Process Our process typically begins with a brief virtual call to understand your background and motivations. This is followed by 3‑5 interviews with team members, a possible case study or technical assessment, and a final selection stage. We strive to provide timely feedback and an engaging experience. Key Responsibilities Lead the development and execution of Design Quality and Reliability strategies for high‑complexity medical systems, focusing 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 covering system architecture, PCB design, signal integrity, power management, EMI/EMC and environmental robustness. Provide technical quality oversight during electrical hardware design reviews, ensuring best practices in circuit design, component selection and failure mode mitigation. Lead and support FMEA (Design and Process) activities with a focus on electrical and system‑level risks, implementing effective control plans. Collaborate with R&D teams to validate critical design inputs such as performance, safety, reliability and usability using statistical methods and tailored test plans. Ensure robust verification and validation of electrical systems, including environmental testing, long‑term reliability (MTBF) and compliance with IEC 60601, IEC 61010, IEC 62366. Analyze development and field failure data to identify root causes in hardware performance and drive corrective actions and design improvements. Champion DfX principles – DfR, DfT, DfM – within electrical and system design processes. Ensure completeness and compliance of Design History Files (DHF) and Device Master Records (DMR), focusing on hardware documentation, schematics, BOMs and test reports. Serve as a technical quality advisor to engineering teams, guiding 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 related 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 Green Belt certified; progression toward Black Belt is a plus. Experience with root‑cause analysis of hardware failures using 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. Proficiency with quality tools and processes: CAPA, Change Control, Risk Management, Design Reviews, Verification & Validation. Excellent communication and collaboration skills, able to work effectively in multidisciplinary, agile R&D environments. Willingness to work onsite at least 3 days per week (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 drive for continuous improvement. Strong communicator who can translate technical risks into business impact. Team player with 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. Equal Opportunity Amaris Consulting is proud to be an equal opportunity workplace. We are committed to promoting diversity within the workforce and creating an inclusive working environment. For this reason, we welcome applications from all qualified candidates, regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability or other characteristics. Seniority level

Mid‑Senior level Employment type

Internship Job function

Quality Assurance Industries

IT Services and IT Consulting

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