Description:
Our products are designed to make it easy for emergency medical responders to provide better patient care. The current market needs for improved resuscitation and Mass Casualty/Pandemic Planning have increased the demand for our leading edge ventilation solutions.
We are seeking an eager, dedicated and goal-oriented Mechanical Engineer to join our R&D/Engineering team and help develop state of the art products for emergency and respiratory care as well as working closely with QA manager in new products’ registrations and maintaining the company quality management system.
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.
- 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.