Goddard is seeking a Verification and Validation Engineer to join our team. The V&V Engineer is responsible for the preparation, execution, and documentation of testing activities in support of new product introductions.ng from a database of requirements that encompasses the Company product platforms, the Verification and Validation Engineer 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 performance and validation of user requirements. The V&V Engineer owns formal verification activities including planning, de-risking, protocol development, test execution, data analysis and report generation.
About the Role:
- 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.
- Execute the verification and validation of product design including requirements analysis, traceability, and testability assessment.
- 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 product design.
- Continuously monitor risk and mitigate as appropriate.
- BS degree in Physics, Electrical, Mechanical and/or Biomedical Engineering or equivalent discipline or equivalent work experience.
- 1-4 years’ experience in conducting verification and validation of electro/mechanical systems in a regulated industry.
- Medical device development experience along with a solid working knowledge of FDA Quality System Regulations and ISO 13485, and IEC 60601 is highly preferred.
- Experience with:
- Research, development, and product testing.
- Writing procedures for others to follow.
- With data and failure analysis.
- Broad measurement instrument knowledge.
- Knowledge and understanding of engineering fundamentals.
- Demonstrated problem solving ability and techniques.
- Ability to analyze requirements and develop a risk-based approach to testing.
- Familiarity with:
- Measurement equipment, and other pneumatic element
- Requirement management
- Main standards applicable to the development of medical devices (i.e. IEC 60601-1, ISO 10993, etc.)
- Knowledge of statistical techniques for experimental design and data analyses.
- 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 (JMP, Minitab, ReliaSoft, and/or Python).
- Aptitude for learning new technologies.
- Ability to work independently and in a multi-function, interdisciplinary team environment.
- Self-motivated and able to self-prioritize.
- Excellent problem-solving skills.
- Excellent verbal and written communication skills.
Please note: Presently, Goddard does not sponsor employment visas.
Goddard believes that everyone is entitled to fair opportunities and equal employment rights. We comply with all applicable laws prohibiting discrimination in hiring and the terms and conditions of employment including, but not limited to, compensation, promotion, discipline, or termination. Goddard is firm on its policy to provide equal employment opportunity for all employees and applicants on the basis of qualification and merit and will not discriminate on the basis of race, color, creed, religion, national origin, age, disability, genetic information, sex, sexual orientation, gender identity, marital status, veteran status, public assistance status, membership or activity in a local commission, or any other legally protected status in accordance with applicable local, state, and federal laws.