Senior Design Quality Engineer

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

Company Description

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.

Job Description

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.

Key Responsibilities

• 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.

Essential Requirements

• Bachelor's degree
  or
  Master's degree
  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
  .

Preferred Competencies

• 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.

Education

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

Work Experience

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

Additional Insights

Department:
Design Quality / R&D – IGT Systems

Contract Type:
Contract

Working Hours:
40 hours per week

Location:
Eindhoven, Netherlands

Interested?
Please send your CV to
Miguel Gomes
at
m.-
or contact directly at

.