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.

QUALIFICATIONS:

• Bachelor’s or Master’s degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, or a related technical field.
• A minimum of 3 years of experience in medical device testing, verification & validation, and compliance, with a focus on coronary catheters or similar cardiovascular devices.
• 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, performance, and biocompatibility 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 fast-paced environment.
• Excellent communication skills and the ability to work effectively across teams and departments.
• Ideally experience with statistical analysis tools for evaluating testing data.
  Job Types: 100%, Permanent

Benefits:

• Company events
• Free drinks
• Free parking

Schedule:

• 8 Hour Shift
• Day shift
• Monday to Friday

Work Location: In perso

• Conduct comprehensive 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, and risk management 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.
• Provide guidance and expertise on testing methodologies specific to coronary catheter devices and its packaging, including mechanical, performance and biocompatibility testing.
• Perform 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.
• Collaborate with cross-functional teams, including regulatory affairs, quality assurance, and manufacturing, to integrate compliance throughout the product lifecycle.
• Prepare technical documentation required for regulatory submissions, including risk management reports, test reports, and design history files (DHF).
• Assess design changes or improvements based on testing results, regulatory feedback or supplier-initiated changes.
• Support the regulatory submission process, including 510(k) filings, CE marking, and other approvals, ensuring all required tests and documentation are in order.