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R&D Engineer

vor 1 Monat

Winterthur, Schweiz Acrostak Vollzeit
International Sales & Marketing Manager presso Acrostak

Job Title: Research and Development (R&D) - Medical Devices

Location: Winterthur, SWITZERLAND - valid Swiss permit or European Union (EU) citizenship is required for this position.

Job Type: Full-time

Department: Research and Development

Job Summary:

We are seeking a highly motivated and detail-oriented R&D Engineer with expertise in testing and compliance for medical devices, ideally within the coronary catheter industry. The successful candidate will play a critical role in ensuring our existing coronary catheter products meet the required safety, performance, and regulatory standards for market release. This role offers an opportunity to contribute to the development of life-saving technologies while ensuring the highest standards of quality and compliance.

Key Responsibilities:

  • Conduct hands-on testing on existing coronary catheter products to ensure they meet regulatory requirements (e.g., ISO 13485, MDR, FDA) and safety standards.
  • Review and assess the device’s design, functionality, related manufacturing processes to identify areas requiring modifications or improvements to meet compliance requirements.
  • Develop and execute verification & validation protocols for the coronary catheter, ensuring thorough documentation of all test results.
  • Assemble in-house test setups necessary for the execution of tests.
  • Establish and optimize manufacturing processes.
  • Provide guidance and expertise on testing methodologies such as but not limited to packaging, product and process performance.
  • Support risk assessments in alignment with ISO 14971 and other applicable standards to mitigate potential risks and ensure patient safety.
  • Perform gap assessment on new or revised product-specific technical standards e.g. ISO 10555-1.
  • Assess design changes or improvements based on testing results, regulatory feedback or supplier-initiated changes.
  • Collaborate with cross-functional teams, including regulatory affairs, quality assurance, and manufacturing, to integrate compliance throughout the product lifecycle.

Qualifications:

  • Bachelor’s or Master’s degree in Biomedical Engineering, Mechanical Engineering, Materials Engineering or a related technical field.
  • A minimum of 3-5 years of experience in medical device testing, verification & validation, and compliance.
  • Knowledge of MDR and FDA regulations, ISO 13485, and other relevant standards for medical device compliance.
  • Experience in designing, manufacturing and conducting verification & validation testing of medical devices, ideally for coronary catheters, including mechanical and performance tests including materials science and performance characteristics.
  • Understanding of risk management principles and experience conducting risk assessments for medical devices, particularly in the cardiovascular space.
  • Familiarity with design controls and creating design history files (DHF).
  • Proficient in technical writing, with the ability to prepare comprehensive test reports, verification and validation protocols.
  • Strong attention to detail and the ability to independently manage multiple projects and priorities in a highly regulated environment.
  • Ideally experience with statistical analysis tools for evaluating testing data.
  • Good English and German language skills.

Job Types: 100%, Permanent

Benefits:

  • Company events
  • Company pension
  • Free drinks
  • Free parking
  • Wellness program

Schedule:

  • 8 Hour Shift
  • Day shift
  • Monday to Friday

Ability to commute/relocate:

  • 8409 Winterthur, ZH: Reliably commute or planning to relocate before starting work (Preferred)

Please send your CV to qa@acrostak.com

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