This role leads design and development activities for medical devices and surgical instruments, combining CAD, finite element analysis, verification/validation, and cross functional execution from concept through transfer to manufacturing. The engineer applies knowledge of surgical procedures, collaborates with clinical advisors, and supports regulatory and technical documentation to deliver safe, effective, and cost optimized solutions for customers.
The candidate will be responsible for managing the following activities:
create and iterate 3D designs and detailed drawings using SolidWorks, ensuring DFM/DFA readiness and revision control compliance;
prepare and deliver clear written and oral communications to stakeholders, including design reviews and executive updates;
plan and manage projects, schedules, and milestones, coordinating across R&D, Quality, Regulatory, Manufacturing and Marketing;
execute and document Technical File activities, including verification and validation protocols, reports, and objective evidence;
support manufacturing and suppliers to optimize process capability and cost based on production process knowledge;
assist with patent searches, invention disclosures, application preparation, and patent review/analysis in collaboration with IP counsel;
define mechanical test protocols and author test reports aligned to product requirements and applicable standards;
utilize knowledge of surgical workflows to translate clinical needs into innovative, user-centered product requirements and designs;
interface with clinical advisors to collect input for design and evaluation of medical devices, including simulated use and OR observations where appropriate.
The resource should also have the following skills:
Hard Skills
Master’s degree in Mechanical or Biomechanical Engineering;
CAD modeling and design experience with SolidWorks;
demonstrated project management capabilities spanning planning, communication, and cross-functional coordination;
working knowledge of regulatory pathways and requirements (FDA, CE, TGA);
proven experience preparing exhaustive Technical Files, including V&V documentation;
experience collaborating with manufacturing and suppliers to drive process-based cost optimization;
exposure to IP processes, including drafting support and prior-art/patent analysis;
competence in defining mechanical testing protocols and executing/reporting results;
English required, Italian desider but not mandatory.
Soft Skills
clear, concise written and oral communication for technical and executive audiences;
structured project planning and on-time execution across multiple stakeholders;
customer orientation with the ability to translate clinical and commercial needs into engineering requirements;
practical understanding of production processes to guide design-for-manufacture and cost-down initiatives.
What we offer:
permanent contract;
flexible working hours;
carpooling organized by Medacta;
incentives for mobility by public transport;
advantageous conventions;
growth opportunity, working in a continuously improving and expanding environment;
annual salary review linked to performance and professional development;
continuous training.
Medacta International is an equal opportunities employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, colour, religion, gender, gender identity, sexual orientation, national origin, disability or protected veteran status.