Medical Device R&D Project Lead — Flexible Hours, Design & V&V

Medacta International; Rancate; Vor Ort; CHF 90.000 - 130.000; Vollzeit

Benefits dieser Stelle

Permanent contract

Flexible hours

Carpooling organized by Medacta

Public transport incentives

Professional development

Continuous training

Zusammenfassung

Medacta International is seeking a Mechanical/Biomechanical engineer to lead design and development of medical devices and surgical instruments, combining CAD, FEA, verification/validation, and cross-functional execution from concept through transfer to manufacturing.

The role requires translating clinical needs into user-centered product requirements, collaborating with clinical advisors, and supporting regulatory documentation to deliver safe, cost-optimized solutions for customers.

Qualifikationen

• Master’s degree in Mechanical or Biomechanical Engineering.
• CAD modeling and design experience with SolidWorks.
• demonstrated project management 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 patent analysis.
• English required, Italian desider but not mandatory.

Aufgaben

• 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.

Kenntnisse

SolidWorks CAD

Project management

Regulatory knowledge

Technical Files prep

Manufacturing collaboration

IP processes exposure

Mechanical testing protocols

English language

Italian language

Ausbildung

MSc Mechanical/Biomechanical

Tools

V&V documentation

Jobbeschreibung

Medacta International is seeking a Mechanical/Biomechanical engineer to lead design and development of medical devices and surgical instruments, combining CAD, FEA, verification/validation, and cross-functional execution from concept through transfer to manufacturing.

The role requires translating clinical needs into user-centered product requirements, collaborating with clinical advisors, and supporting regulatory documentation to deliver safe, cost-optimized solutions for customers.