Growing commercial stage medical device manufacturer with sophisticated diagnostic instrumentation that detects preclinical manifestations of a progressive disease that impacts nearly 200 million people worldwide. The early detection it provides spares a lifetime of diminished capacity.
The skilled engineer in this challenging role will provide mechanical engineering expertise to support the design, transfer and manufacture of electro-mechanical medical devices. He or she will be a key member of the product development team transitioning the product for effective scale up using best practice engineering concepts.
- Initiate mechanical engineering activities to effectively design complex electro-mechanical medical devices and support the production environment.
- Create and interpret SolidWorks CAD models to define component, product and specification needs.
- Support the company’s Quality Assurance activities and policies and proactively ensures regulatory compliance (ISO and FDA).
- Identify critical component design requirements and inspection plans, assist in developing manufacturing and assembly plans and implementation strategies to ensure design requirements are consistently met.
- Evaluate mechanical and electromechanical systems and products, diagnoses product failure modes and performs root cause nonconformance analysis.
- Actively participate in project teams representing the engineering department, ensuring project schedules and objectives are met.
- Create and maintain in-process work instructions and test plans. Develop and execute process and product verifications and validations.
- Work with the Quality team to ensure that all components, design, and products meet or exceed customer expectations with a high level of reliability and consistency.
- Proactively identify assembly and production related issues and implement timely solutions related to product design and manufacturing and implement engineering design changes.
- Analyze product design and establishing effective test plans and methods to assure product reliability.
- Identify tooling, equipment and fixturing needs to create or improve manufacturing processes to ensure best product performance.
- Design manufacturing fixtures and process equipment required to test and assemble the product.
- BS Mechanical, Manufacturing/Industrial or Electromechanical Engineering.
- 4+ years mechanical or electro-mechanical design and/or manufacturing engineering experience in medical device capital equipment or other exacting, regulated industry.
- Proficient SolidWorks 3D CAD.
- Experience with IPC-J-STD-001 and/or IPC-A-610 a plus.
- Self-starter and with the ability to work well in a start-up environment.