| Location | Eindhoven, Netherlands |
|---|---|
| Business Sector | Medical Device |
| Contact email | |
| Job ref | 26105 |
| Published | about 6 hours ago |
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 m.gomes@panda-int.com or contact directly at +31 20 20 44 502.