Lead Mechanical Engineer Jobs

RESPONSIBILITIES include, but not limited to the following:

· Design and perform experiments to conclude the best approach to create a great medical device.

· Use analysis, modeling, and various prototyping techniques to develop components and systems as part of the whole device.

· Using your experience with manufacturing processes and material, efficiently design components for assembly, testing and manufacturing.

· Efficiently analyze problems, and use your experience and knowledge of engineering fundamentals to solve these problems.

· Perform product and processing tests, including preparation and follow-up paper work.

· Design and develop new or improve current products using SolidWorks.

· Achieve “proof of concept” on preliminary products.

· Create new and maintain existing assembly and service procedures, products’ instructions, engineering changes, products’ specifications and Bill of Materials.

· Manage and co-ordinate third-party standards testing.

· Analyze designs and systems for compliance to applicable products’ standards.

· Assist QA manager to prepare Device Master Record (DMR) and product registration documentation.

· Manage, monitor and make corrective/preventive actions for nonconformities.

· Ensure regulatory quality systems requirements (ISO 13485) are met.

· Support manufacturing activities including but not limited to sustaining engineering, ECR/ECN, root cause analysis and design change.

QUALIFICATIONS:

· Degree in Mechanical or Electromechanical Engineering.

· 3-5 years Management experience

· Solid Leadership Skills

· Minimum of 5 years of proven experience in pneumatic and electro pneumatic development ideally in medical device development.

· Proficiency with SolidWorks 2016 or higher, GD&T and MS Office Suite.

· Full knowledge of the complete development process from concept to manufacturing, project planning and project management.

· Experience with C/C++ and Keil u-Vision MDK-ARM is a huge asset.

· Extensive knowledge of process control, risk management and medical device regulations.

· Proficient in interpreting work related documents including; engineering drawings, bill of materials, engineering change notices and regulatory specification requirements.

· Ability to produce clear and comprehensive written procedures and reports.

· Excellent hands on experience.