Senior Test and Verification Engineer
Midmark CorporationAbout the role
JOB SUMMARY:
The R+D Test & Verification Engineer II is a part of a team developing new products for the medical, dental, and animal health markets. They design, document, and execute verification electromechanical tests for medical devices, systems, and components using various tools and methods. The R+D Test & Verification Engineer collaborates within a team to ensure the delivery of high-quality software and system solutions, adhering to quality processes and procedures.
ESSENTIAL/PRIMARY DUTIES:
- Designs, reviews, and executes verification protocols for medical devices, software, and firmware at the system level using various test methodologies for manual and automated testing.
- Leads collaboration within the functional team to create, review, and improve verification plans and traceability matrices.
- Helps ensure conformance to applicable ISO standards and FDA regulations.
- Collaborates within a team to ensure the delivery of high-quality software and system solutions.
- Adheres to established quality assurance and design verification processes and practices and identifies areas for improvement.
- Develops and validates test methods and protocols based on defined requirements for manual and automated testing.
- Documents test results in a clear and concise manner and leads collaborative efforts resulting in improved verification practices and comprehensive traceability matrices.
- Conducts compression and tensile analysis and product destructive tests using measuring equipment to determine ultimate yield or tensile strength, service life, or other critical performance characteristics.
- Analyzes test data and generates reports that detail the results of product testing, including product performance, material performance, failure modes, correlation studies, and other relevant analysis.
- Executes basic automated tests using multiple systems, platforms, environments, or browsers.
- Conducts design of experiments (DOE) to understand the impact of variability on product performance.
- Expands problem definition, integrates new information and different perspectives, and chooses optimal solution based on evidence.
- Applies advanced engineering methods and tools to solve engineering problems.
- Conceptualizes, analyzes, and designs complex parts and assemblies for testing systems using 3D modeling and fabrication tools in order to enhance Midmark testing capabilities.
SECONDARY DUTIES:
- Follows Midmark processes for Design Controls of Medical Devices or the Software Development Lifecycle (SDLC) for software products as applicable.
- Communicates to both technical and non-technical stakeholders. Makes informed decisions within assigned tasks/projects and takes ownership of the outcomes.
- Identifies and contributes to process improvements utilizing six sigma techniques.
- Assists in identifying and evaluating risks, contributes to risk mitigation.
- Evaluates capital equipment needs and derives new equipment based on project needs.
- Sets up test environments and tools, including computers, IT infrastructure, test fixtures, data acquisition tools, etc.
EDUCATION and/or EXPERIENCE:
Bachelor's degree in engineering or related field and 4 years of relevant experience, or master’s degree in above fields and 2 years of engineering experience.
COMPETENCY and/or SKILL:
- Working knowledge of the requirements-gathering process to drive a deeper understanding and distillation of the requirements and specifications to derive effective test scenarios
- Clear understanding of Verification Plans, Protocols, Reports and Trace Matrix
- Strong analytical and communication skills (written & verbal)
- Ability to work under pressure and meet deadlines
- Familiarity of FDA regulations and ISO standards
- Solid-working knowledge of mechanical and electrical testing systems and tools, such as LabVIEW, PLCs, CAN devices, etc.
- Software Development Testing roll
- Possesses the ability to define and analyze complex problems
- Ability to generate alternatives and take reasonable risks to solve technical problems
- Knowledge of statistical analysis tools and software, such as Microsoft Excel VBA, R, Python, etc.
- Ability/willingness to pursue a green belt in Design for Six Sigma
SUPERVISORY RESPONSIBILITIES:
- Provides leadership, coaching, and/or mentoring to co-ops and level I engineers.
Founded in 1915, Midmark Corporation is the only company transforming healthcare experiences through innovative design within the medical, dental and animal health environments. With more t
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