Senior Design Quality Engineer Eindhoven • Panda International

Senior Design Quality Engineer | Medical Devices | ISO 13485 / FDA / IEC Environment

A global leader in medical technology and innovation is seeking a Senior Design Quality Engineer – Products & Systems to join its IGT Systems business within the Patient Safety & Quality organization. The company focuses on developing life-enhancing imaging and therapy technologies that improve clinical outcomes worldwide. Operating in a highly regulated environment, the team adheres to FDA (21CFR820), ISO 13485, EU MDR, and IEC standards, continuously driving quality and reliability improvements across product lifecycles.

As a Senior Design Quality Engineer, you will play a key role in setting and achieving Quality and Reliability targets for IGT Systems products. You will act as a trusted advisor to R&D and cross-functional teams, ensuring that all design and development activities comply with quality standards, design control processes, and regulatory requirements.

You will also work closely with post-market teams to analyze field data, identify improvement opportunities, and drive design changes that enhance product safety, effectiveness, and reliability.

• Define and manage holistic patient and user safety, quality, and reliability strategies across product lifecycles.

• Develop and oversee Quality Plans that cover all design and manufacturing stages.

• Validate key design inputs including usability, reliability, performance, and safety, ensuring statistical confidence and reliability levels.

• Provide effective oversight of Design Controls, risk management activities, and quality assurance during development.

• Lead problem-solving and root cause analysis for quality-related issues.

• Collaborate with post-market teams to analyze product performance and drive design/process improvements.

• Act as subject matter expert for design quality, ensuring all design requirements meet internal and external quality standards.

• Contribute to requirements engineering, CTS/CTQ flow-down, and integration with medical device development.

• Bachelor’s degree (12+ years) or Master’s degree (8+ years) in Engineering — preferably in Quality, Reliability, Mechanical, Electronics, or related disciplines.

• Proven experience in Quality or Reliability Engineering within medical device or aerospace industries.

• Background in R&D processes and product/software development desirable.

• DfSS Green Belt certified (or willingness to progress to Black Belt).

• Strong knowledge of problem-solving methodologies (e.g., RCA, FMEA).

• Familiarity with global medical device regulations and standards: 21CFR820, ISO 13485, EU MDR, IEC 60601, IEC 62366, ISO 14971.

• Proven ability to develop detailed Quality and Reliability Plans for medical product development.

• Experience leading Risk Management and FMEA activities with appropriate control measures.

• Strong command of Design Controls and Design Reviews to ensure robust, safe, and compliant designs.

• Partner effectively with Verification & Validation teams to ensure complete test coverage and usability testing.

• Competence in Systems Engineering methodologies and tools.

• Experience reviewing DHF and DMR documentation.

• Strong communication, documentation, and stakeholder management skills.

• Willingness to work at least 3 days per week onsite.

• Analytical, self-driven, and adaptable, with a continuous improvement mindset.

• Ability to combine conceptual and practical thinking to deliver sustainable results.

• Customer-focused, team-oriented, and skilled in stakeholder communication.

• Strong reporting and consultancy abilities, with project management discipline and a sense of urgency.

• Bachelor’s / Master’s degree in Mechanical Engineering, Electronics Engineering, Science, or equivalent.

• Minimum 5 years (Bachelor’s) or 3 years (Master’s) experience in Quality Engineering, Safety Engineering, or R&D Engineering, preferably in regulated industries.

Department: Design Quality / R&D – IGT Systems
Contract Type: Permanent (Full-Time)
Working Hours: 40 hours per week
Location: [Typically Eindhoven, Netherlands – if known]

Interested?
Please send your CV to Miguel Gomes at via de button "Solliciteer nu" op deze pagina. or contact directly at +31 20 20 44 502.