Essential Functions & Accountabilities: Create testable design inputs from user needs, develop protocols and execute testing. Design and develop mechanical systems and components for medical devices. Conduct feasibility studies and provide technical support for new products and existing products. Create and maintain 3D models, assemblies, engineering drawings and specifications according to ASME Y14.5. Ensure product compliance with relevant regulatory and industry standards. Collaborate with cross-functional teams including operations, supply chain, regulatory and quality to ensure timely delivery of projects. Manage the entire change control process from initiation to production. Participate in design reviews and provide constructive feedback to improve designs.Experience:Minimum of 4 years of experience in R&D or sustaining engineering for medical devicesEducation:Batchelor degree or higher in Mechanical Engineering or related fieldQualifications, Knowledge, Skills and Abilities:Strong knowledge of Mechanical Engineering principles, including mechanics and materials science.Proficiency in Solidworks, 3D modelling, assemblies and engineering drawings according to ASME Y14 series. Experience with product development processes, including design controls, risk management, and design verification and validation.Requires Medical Devices development experience and understanding of associated regulatory compliance such as IEC 62304 and medical device design controls (21 CFR Part 820).Excellent problem-solving and analytical skills.Excellent English language communication skills (written and oral). Ability to author reports, protocols, procedures, presentations and other related documents. Ability to effectively communicate to peers as well as management.Ability to work in a fast-paced high-pressure environment and meet project deadlines.Work Environment:Hybrid work environment offered, minimum 2/5 days in the office, or as required by the business.Mainly office work combined with ands-on work in engineering lab to build prototypes and/or troubleshoot electronic or mechatronic devices.Travel: May be required to travel up to 10% of time. Cooper's management team is committed to the development of and implementation of the quality management system and maintaining its effectiveness by communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements.
