Job Description
Principal R&D Orthopaedic Engineer Would you like to join an exciting start-up company, offering great opportunities and an exciting time to grow and innovate? Our client is a start-up company specializing in the design and manufacture of orthopaedic implants, providing innovative solutions to improve patient outcomes in the field of musculoskeletal healthcare. Our client’s business is at the juncture where they need new talent to come onboard and support their mission. The successful candidate will provide product and project leadership with a hands-on approach. Working closely with technical and commercial colleagues, you will help our client to drive towards market approval, acceptance, and expansion. Overall, this role offers the candidate the opportunity to design, manage, grow, and lead within a small organisation which has the ambitions, plans and funding necessary to grow quickly into a new market within the field of orthopaedics. The Principal R&D Engineer Orthopaedic role offers unparalleled personal development opportunities within a strong positive cultural work environment. This is a full-time role that carries with it an attractive package to include market leading salary, a benefits package including options for Pension, Healthcare, and Death in Service provisions. You will work in a supportive and collegiate environment that affords flexibility and a hybrid workplace Roles and Responsibilities · Reporting to the Technical Operations Director you will be responsible for the Research & Development of the companies Thumb Based Orthopaedic implant. · Develop and support design characterization activities, test method development, and verification and validation activities. · Work with engineers in early-stage development and creation of working prototypes, specifications, and documentation to support timelines. · Make sure all solutions meet critical design prerequisites including patient and customer safety, mechanical and biological suitability. · Strong knowledge and understanding of 3D design with SolidWorks or similar. · You will be required to liaise with customers to provide appropriate design solutions for specialist patent-specific orthopaedic devices. · Develop and maintain productive relationships with key clinical advisors. · Liaise with all stakeholders and the commercial leadership of the company to create design input and output matrices for next generation product designs. · Design and validate test methods. · Contribute to the company’s IP portfolio with novel concepts for patent filings. · Manage development projects in compliance with approved procedures and in adherence to ISO and FDA regulations. Qualifications and Experience Required · Engineering/Science degree or equivalent required (Master's degree qualification preferred) · Five years experience in Orthopaedic implant product design and development. (Orthopaedic extremity experience preferred). · Experience with Orthopaedic implant testing per regulatory body expectations · Experience with Orthopaedic implant submissions through FDA preferred · Experience with IP generation in the Orthopaedic implant space · Engineering/Science degree or equivalent required Skills Required · Strong oral and written communication skills and proven ability to work well in small team environments. · Proven creative design and development skills in FDA regulated environments. · Advanced competency in best practice product design methods. · Advanced competency in 3D design with SolidWorks or similar. · Knowledge of engineering and implants materials · Basic competency in statistical analysis techniques. · Critical thinking and foresight in rapidly evolving situations. · Innovative and economical problem solving. · Experience working within Quality Systems in compliance with ISO 13485/ FDA CFR 820. · Organisational skills to lead multi-functional teams through various projects