Senior Design Quality Engineer [F/M/X]

Who are we?

Amaris Consulting is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1,000 clients across the globe, we have been rolling out solutions in major projects for over a decade – this is made possible by an international team of 7,600 people spread across 5 continents and more than 60 countries. Our solutions focus on four different Business Lines: Information System & Digital, Telecom, Life Sciences and Engineering. We’re focused on building and nurturing a top talent community where all our team members can achieve their full potential. Amaris is your steppingstone to cross rivers of change, meet challenges and achieve all your projects with success.

At Amaris, we strive to provide our candidates with the best possible recruitment experience. We like to get to know our candidates, challenge them, and be able to give them proper feedback as quickly as possible. Here's what our recruitment process looks like:

Recruitment Process

Brief Call: Our process typically begins with a brief virtual/phone conversation to get to know you! The objective? Learn about you, understand your motivations, and make sure we have the right job for you!

Interviews (the average number of interviews is 3 - the number may vary depending on the level of seniority required for the position). During the interviews, you will meet people from our team: your line manager of course, but also other people related to your future role. We will talk in depth about you, your experience and skills, but also about the position and what will be expected of you. Of course, you will also get to know Amaris: our culture, our roots, our teams and your career opportunities!

Case study: Depending on the position, we may ask you to take a test. This could be a role play, a technical assessment or a problem‑solving scenario, etc.

As you know, every person is different and so is every role in a company. That is why we have to adapt accordingly, and the process may differ slightly at times. However, please know that we always put ourselves in the candidate's shoes to ensure they have the best possible experience.

We look forward to meeting you!

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.
• Analyse 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.

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.

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