As Mechanical Engineer, within Distalmotion’s Instruments – Product Improvement team, you will be responsible for driving product optimization initiatives with a strong emphasis on cost reduction, manufacturing efficiency, and continuous product improvement for the Instruments of the surgical system.
The Mechanical Engineer brings solid experience in component and tooling design with associated impact analysis (impact on design verification, risk assessment, quality and manufacturing costs) and root cause investigation of clinical complaints and/or non-conformities.
Tasks: Design & Cost Optimization• Specify design, prototype, and implement mechanical components and custom tooling/fixtures with a strong focus on Design for Manufacturing, Assembly and Cost (DFM/DFA/DFC).
• Identify, justify and execute cost reduction opportunities on existing instruments without compromising performance, quality or safety.
• Collaborate with internal and external stakeholders from manufacturing of prototypes to testing and industrialization of the products.
Impact analysis• Perform comprehensive impact analysis of the proposed design changes, evaluating effects on manufacturing processes, unit costs, risk management and design verification.
• Evaluate financial impact of proposed design changes, including tooling/fixture investments, scrap reduction and cycle time improvement.
• Define technical.
Supervise and participate to design verification.
• Collaborate with internal teams (Ops, QA, RA).
• The compliance with the applicable laws and standards and the design control practices is a must (e.
ISO 13485, FDA 21 CFR 820, MDR).
Continuous Improvement• Investigate clinical complaints and production non-conformity.
• Lead root cause analysis and manage Corrective and Preventive Actions to drive continuous product quality and reliability improvements.
RequirementsEducation & Experience• Mechanical, microtech.