Senior Research And Development Engineer

Job Title: Senior R&D Engineer – Medical Devices

Location:
Baden-Württemberg, Germany

Job Type
: Full time, Permanent

A pioneering medical device company specializing in innovative cardiovascular and Class III implantable devices is seeking an experienced
Senior R&D Engineer
to join its growing engineering team in Germany. This position offers the opportunity to play a key role in the design, development, and clinical evaluation of cutting-edge products that improve the lives of patients worldwide.

The ideal candidate is a German professional with at least
4–5 years of experience
in the medical device industry, demonstrating both technical excellence and leadership potential. Experience with similar products is a strong plus. This role provides a clear development pathway toward a
Team Lead R&D
position.

Responsibilities:

• Lead and participate in the design, development, and optimization of advanced medical devices, particularly in the cardiovascular and interventional domains (e.g., PTCA/PTA).
• Drive innovation in design methodologies, prototyping, and experimental validation to address complex biomechanical and physiological challenges.
• Conduct feasibility studies, risk analyses, and verification/validation tests.
• Collaborate closely with Quality Management and Regulatory Affairs to ensure full compliance with ISO 13485, ISO 14971, MDR, and FDA requirements.
• Support and prepare for audits, ensuring that design control documentation and risk management files meet regulatory standards.
• Formulate and manage detailed project plans covering design, development, risk management, quality assurance, and regulatory pathways.
• Coordinate effectively with Production, Supply Chain, Quality, and Regulatory teams to ensure smooth technology transfer from R&D to large-scale manufacturing.
• Work directly with clinicians and key opinion leaders to translate clinical needs into engineering solutions and incorporate feedback into product design.
• Analyze and improve development and production processes for enhanced efficiency and reliability.
• Support equipment qualification and process validations to ensure robust, reproducible manufacturing.
• Develop and standardize testing methodologies for verification and validation activities.
• Prepare comprehensive technical documentation, including design history files, technical reports, risk analyses (DFMEA, PFMEA), and validation studies.
• Maintain meticulous records of design inputs, materials, fabrication processes, and inspection methodologies to ensure traceability and compliance.

Requirements:

• Degree in Engineering (e.g., Medical, Mechanical, or Process Engineering) or a related field.
• Minimum 4–5 years of experience
  in product design, development, and manufacturing within the
  medical device industry
  (Class III preferred).
• Strong proficiency in
  CAD software
  (preferably SolidWorks) and familiarity with manufacturing processes.
• In-depth knowledge of
  ISO 13485
  ,
  ISO 14971
  ,
  MDR
  , and
  FDA regulations
  .
• Experience working at the R&D/Quality interface, with an understanding of audit preparation and design control documentation.
• Excellent analytical and problem-solving skills, with a structured and solution-oriented approach.
• Demonstrated
  leadership potential
  and the ability to contribute to the structural development of the engineering department.
• Strong communication and teamwork abilities; capable of working cross-functionally in a dynamic, international environment.
• Good command of both
  German and English
  (spoken and written).
• Experience in the
  cardiovascular field
  is a plus, but not mandatory.

Please reach out to for further detail.