Job Summary

The R&D Test Engineer will be a highly motivated individual responsible for development of testing strategies, including methods, associated fixtures and validation and for the completion and reporting of testing. Testing will include functional testing, performance testing, and validation testing, to ensure that the products meet regulatory standards and customer requirements. Coordinate testing and resourcing requirements to ensure timelines are met. Maintenance of the test laboratory and equipment ensuring a tidy and safe environment.
Hard working and highly motivated individual, with attention to detail. The candidate must have a background in Science or Engineering and should have excellent writing and oral skills. Ability to work both independently and as part of a team.  Able to work in a dynamic environment with changing priorities.

Role and Responsibilities

• The role of a test engineer involves ensuring the safety and effectiveness of Biomimetic Innovations and its clients’ products through rigorous testing procedures.
• Collaborate with cross-functional teams to understand testing requirements and specifications for new products. Manage multiple testing projects ensuring completion within project timelines.
• Responsible for designing, developing and executing test plans and protocols to evaluate the performance and functionality of products simulating real-world clinical situations.
• Design and develop test fixtures and equipment to ensure accurate and efficient testing of the products.
• Create detailed documentation and specifications for test fixtures, including assembly instructions, operating procedures, and maintenance guidelines.
• Collaborate with suppliers and vendors to source and procure necessary components and materials for test fixtures.
• Execute testing on prototypes and final products. Document test procedures, results, and findings, and communicate them effectively to stakeholders, including product development teams, clients and regulatory authorities. Ensure traceability throughout and compliance within the QMS.
• Analyze test results using statistical methods to draw meaningful conclusions to support development decisions. Undertake Root Cause Analysis on failures to identify corrective actions.
• identify any issues or defects, and propose solutions or improvements to enhance the device’s/component’s/Material’s performance.
• Participate in risk analysis and validation activities to ensure that products meet safety and quality standards.
• Maintain the R&D lab and its equipment is calibrated and in good order ensuring a clean and safe working environment. Ensure stocks of lab supplies are maintained.
• Implement continuous improvement to develop the laboratory and systems to enhance quality and efficiency of testing throughput.
• Stay updated with the latest industry trends, regulations, and standards related to medical device testing, and continuously improve the knowledge and skills in this field.
• Provide training and mentoring to junior engineers and technicians in methods and best practices.
• Requires attention to detail, critical thinking, problem-solving skills, and the ability to work effectively in a team-oriented environment.
• Support testing requirements of BMI partners as required.
• Provide design services to BMI Partners as required, e.g., PBCI.

Qualifications and Education Requirements

• Adequate theoretical and practical knowledge for the performance of job functions and skills.
• Experience in laboratory practices, lab management preferred.
• Good organizational skills.
• Good attention to detail.
• Excellent verbal and written communication skills.
• Appropriate computer skills.

Note: This description reflects essential functions and does not prescribe nor restrict tasks that may be assigned.