The R&D Project Engineer is responsible for managing the execution of R&D projects for the relevant products, ensuring that they are completed on time, within scope, and budget. Reporting to the R&D Manager, the role involves regular collaboration with internal and external stakeholders.
The candidate will be responsible for managing the following activities:
* develop detailed project plans, timelines, and budgets for R&D projects related to the relevant products and ensure successful execution;
* design and development using CAD, engineering drawings and tolerance analysis. Definition of feasibility of manufacturing and quality control inspection of the devices;
* collaborate regularly with surgeons to gather detailed clinical feedback on product designs, applying their insights to optimize product development. Direct collaboration or through marketing, reps or agents;
* collaborate with engineering, regulatory, and marketing teams to ensure project deliverables for the relevant products meet quality and regulatory requirements;
* support company presence at selected international congresses or design meetings, providing product development input and engaging with surgeons when required;
* manage communication with internal and external stakeholders for the relevant products, providing regular project updates and addressing any risks or issues;
* identify project risks for the relevant products and develop mitigation strategies to keep projects on track;
* ensure optimal use of resources for assigned projects related to the relevant products, working closely with team leads and department heads;
* maintain accurate project documentation for the relevant products and ensure compliance with regulatory requirements for medical devices;
* resolve project-related issues for the relevant products efficiently and in a timely manner, ensuring minimal impact on project deadlines;
* provide leadership and support to project teams working on the relevant products, fostering a collaborative and results-oriented environment.
The resource should also have the following skills:
Hard Skills
1. Master’s or Bachelor’s degree in Engineering, Biomedical Engineering, or related field; PMP certification is a plus;
2. 2+ years of experience in project management within the medical devices industry, with proven success in leading R&D projects;
3. excellent knowledge of CAD systems (Solidworks), definition of tolerances and the preparation of technical drawings;
4. familiar with design control documentation for Medical implants. (e.g. Risk Analysis, Verification/Validation, Design