This list contains only the countries for which job offers have been published in the selected language (e.g., in the French version, only job offers written in French are displayed, and in the English version, only those in English).
The Senior Mechanical Developer leads the end-to-end mechanical design and development of the TULSA-PRO system and future product platforms. This role provides technical leadership, drives system-level design strategy, and ensures alignment with regulatory, manufacturing, and business objectives from concept through product release.
Job Responsibility:
Drive the design and continuous improvement of mechanical aspects of the product
Lead the architecture, design strategy, and system-level integration of mechanical subsystems
Translate user, clinical, and business needs into robust system requirements and engineering specifications
Lead design reviews, risk assessments, and cross-functional technical decision-making
Produce and review DHF and DMR documentation to support transfer to test and manufacturing
Partner with customers, clinical users, marketing, sales, and operations to identify product needs and opportunities for improvement
Lead investigations of product complaints at clinical and customer sites, perform root cause analysis, and drive timely remediation
Contribute to risk management deliverables including hazard analysis and design risk mitigations
Drive design for manufacturability, reliability, serviceability, and cost optimization initiatives
Contribute to a positive, high-performance work culture
Perform all duties in compliance with the quality management system and actively contribute to continuous improvement of the QMS
Requirements:
8+ years of industrial experience
Demonstrated experience leading complex product development efforts from concept through manufacturing transfer
Extensive knowledge of SolidWorks and mechanical system design best practices
Excellent verbal and written communication skills, with the ability to communicate clearly, concisely, and effectively across functions
Strong mechanical aptitude, including the ability to use common shop tools and measurement equipment
Tenacious problem solver who is highly organized, detail oriented, and accountable
Working knowledge of medical device standards and regulations such as IEC 60601-1 and ISO 10993
Deep knowledge of manufacturing processes including machining, injection molding, urethane casting, 3D printing, and sheet metal fabrication
Demonstrated ability to translate user needs into design requirements and technical specifications
Demonstrated ability to troubleshoot complex technical issues, perform root cause analysis, and implement effective corrective actions
Knowledge of ASTM standards and test methods
Strong competency in mechanical engineering fundamentals including kinematics, solid and fluid dynamics, heat transfer, and material strength
Bachelor's degree in mechanical engineering or a related discipline
Nice to have:
Industrial design experience
a design portfolio is an asset
Experience with biocompatibility, and designing for cleaning & disinfection
Experience working with MRI-compatible devices
Knowledge of electromechanical system design and integration
Familiarity with mechatronic component sizing and sourcing
Experience working with adhesives, sterilization methods, and disinfection methods
Experience with statistical analysis and data-driven design decisions
Prior experience mentoring engineers or serving as a technical lead