Test Engineer Lead -V&V
Test Engineer Lead -V&V
Direct Hire- Full benefits
The selected Test Engineer Lead is responsible for the preparation, execution and documentation of testing activities in support of new product introductions. Starting from a database of requirements that encompasses our clients product platforms, the Test Engineer Lead will develop test methods, fixtures and procedures to first characterize and subsequently formally verify product performance.
Testing will be conducted at all levels, from component to sub-assembly to full system, and includes verification of functionality, performance, reliability, FDA/industry compliance and validation of user requirements. The Test Engineer Lead owns formal verification activities including but not limit to: planning, de-risking, protocol development, test execution, data analysis and report generation.
- Review and develop system and sub-system requirements leveraging their in-depth knowledge of the product
- Write detailed test procedures that evaluate product and systems against documented mechanical, electrical and software requirements
- Develop test methods and fixtures for all development testing including verification while collaborating with development teams or outside resources
- Research, recommend and qualify test measurement equipment
- Prepare and execute test method and fixture qualifications. Fixtures may be mechanical, electromechanical, pneumatic, with or without software controls
- Conduct statistical analysis of test results
- Support completion of traceability of requirements through verification and validation reports
- Maintain and control test execution records using good lab practices
- Automate tests where applicable
- Escalate, when appropriate, cross-functional support issues on projects to the Project Manager or to functional leadership
- Actively evaluate projects for opportunities to improve performance
- Continuously monitor risk and mitigate as appropriate
- Coordinate test activities with third party (Test labs) for standard tests, reliability tests
- Bachelor of Science/Engineering degree in applicable engineering field; Mechanical, Electrical, BioMedical. Master is preferred.
- 5+ years experience in a regulated industry required (medical device development experience along with a solid working knowledge of FDA Quality System Regulations and ISO 13485, and IEC 60601 is highly preferred)
- Possess the ability to analyze requirements and develop a risk-based approach to testing
- Familiarity with measurement equipment, preferably including mass flow controllers and other pneumatic elements
- Familiarity with requirement management tools leading to generation of complete traceability matrices (i.e. Doors, Jama, Test Track, etc.)
- Knowledge of main standards applicable to the development of medical devices is highly desired (i.e. IEC 60601-1-1, -2, -6, -8, IEC 60529, ISTA, IEC80601-2-12, IEC 60068-2-64, IEC 60721-4-7, ISO 10993, EU Directive 2012/19/EU, HIPAA etc.)
- Knowledge of statistical techniques for experimental design and data analysis
- Strong design control and documentation skills
- Good technical writing skills, including development of test methods, protocols, reports
- Proficient computer skills with applicable software packages (e.g. Microsoft Office, Microsoft Project, Microsoft Power Point, etc.) and test data analysis software packages (such as Minitab)
- Good communication skills
- Able to learn new technologies, able to handle multi-tasks
- Excellent problem-solving, troubleshooting skills
- Experience with respiratory equipment is a plus
- Team lead, cross function work experience, mentor experience is desired
- Class 3 medical device NPI experience is desired. Knowledge of FDA PMA process is desired.
- Knowledge of Lean manufacturing is a plus.