Design Quality Assurance Engineer

Created in June 2018, Ganymed Robotics ambitions to revolutionize the standard of care in Orthopedic surgery.

Ganymed develops a revolutionary active therapeutic device to assist surgeons during knee replacement surgery. Working in close collaboration with high-volume orthopedic surgeons, researchers, entrepreneurs in Computer-Assisted Surgery and Robotics, the company has filed several patents and has been awarded numerous international and national prices, such as the I-LAB contest.

With a truly innovative user-centered design and novel algorithms to perceive and extract knowledge from the surgical scene in a non-invasive manner, Ganymed improves patient outcome and surgeon experience.

As Design Quality Assurance Engineer, you will be responsible for working as an integral member of the design team ensuring that Ganymed Robotics follows all applicable Design Controls procedures and regulations / standards. Design QA engineer is responsible for company Design Control documents such as standard operating procedures and work instructions and ensuring compliance with ISO 13485 and 21 CFR 820. You will be a key member in the development and commercialization of our products. If you have at least 5 years’ experience in class II/III Medical Device Quality Engineering (specifically with experience in new product development / Design Controls) you should check us out! 

• Assist in the management and definition of the Design Controls process.

• Review and manage all Design Controls, Design History File and Device Master Record documents to ensure compliance to all Ganymed Robotics’ policies and procedures in addition to applicable regulations and standards.

• Lead the risk management process, check risk mitigation effectiveness proof availability

• Check and approve V&V Plan, protocol and reports - help for statistics determination.

• Check and approve Design Outputs (specification and associated documentation related to product and process).

• Other duties as assigned

Requirements 

• Self-starter with the ability to contribute to the efforts of a startup medical device company with minimal supervision

• In-depth knowledge of Design Controls

• Strong proficiency and organizational skills using Microsoft Office Suite, Adobe, and Product Lifecycle Management (PLM) systems

• Experience with electrical and mechanical design and project management

• Strong knowledge of 21 CFR part 820, ISO 13485, ISO 14971

• Strong French and English language fluency / skills 

• Experience working in the medical device industry 

• Must be a team player 

• Must be able to adapt to rapidly changing work environment 

• Strong interpersonal skills to collaborate with individuals across all levels of the company 

Experience  

• Bachelor’s degree in Science, Engineering, Quality, or Manufacturing. 

• 5 Years’ experience with Design Controls within the medical device industry 

• Familiarity with FDA and ISO regulations/standards

• Working knowledge of Device Master Records, Design History File, BOM