Design Verification Engineer
MicroAire Surgical Instruments
MicroAire is a leading designer, manufacturer and distributor of powered surgical instruments, Customer Centric and driven for success. MicroAire is a team dedicated to enhancing quality of life: for surgery for life.
The Design Verification Engineer supports multiple product development teams, including NPD and Sustaining, will develop plans for the appropriate verification and validation of new products, line extensions, and product redesigns. Requires comprehensive mechanical design skills and developing a full understanding of related FDA and international standards.
- Assist in developing test plans for entire NPD projects to address all User Needs, Design Inputs, Usability, and related Risk Control Measures.
- Assist NPD teams in project planning to ensure appropriate time, product, and resources are allocated for successful testing later in project.
- Provide guidance and support for the preparation and execution of verification and validation protocols and reports.
- Track and log V&V activities to ensure full compliance with FDA and international standards.
- Coordinate verification and validation activities with production and/or test houses to ensure that activities are carried out accurately and on schedule.
- Ensure that all verification and validation activities are performed in accordance with SOP’s and FDA/GMP guidelines.
- Evaluate protocols, test results, data analysis, and final reports for compliance to project risk documentation as needed.
- Review and investigate anomalies, deviations, etc. Perform full root cause analysis of failures.
- Author and execute protocols and reports, as needed.
- Perform statistical analysis of results, as needed.
- Design test fixtures, as required.
- Works individually or within a project team. May lead a project team with minimal supervision.
Experience and Qualifications
Education Requirements: BS or MS in Mechanical or Biomechanical Engineering or applicable experience.
Experience Requirements: Prefer three (3) years total design experience with at least two (2) years in medical device industry. Prefer two (2) years involved with product Verification testing.
Job Knowledge, Skills & Abilities
- Proficiency in 2D drafting and 3D modeling, preferably SolidWorks.
- Knowledge of ANSI Y14.5 drafting standards.
- Good understanding of the design of mechanical components and assemblies.
- Basic knowledge of factors that affect the life of re-usable surgical instruments, such as corrosion, wear and thermal cycling.
- Basic knowledge of statistical techniques related to sample size calculation and data analysis.