Medical Device Verification Test Engineer

Pay Range: $50.00hr - $65.00hr

Job Overview:

The New Product Verification Department is devoted to assuring safe, reliable, and effective products that exceed patient, surgeon, and hospital expectations. The department plays a vital role in product and process quality, in new product development and production, and in the quality of robotic product lines, including diagnostic systems, endoscopic instrumentation, and supporting accessories. The Test Engineer will work with a team of dedicated individuals within a product development team to assure the quality of new designs, identify issues related to new designs and processes, and work with other Test Engineers to develop harmonized test methods.

Essential Job Duties: Test Protocol Development, Execution & Reporting:

• Develops high level verification and validation test plans for instrument, accessories, endoluminal, or vision projects.
• Generates and takes ownership of test protocols for Design Verification and Life/Reliability tests.
• Collaborates with Design and Clinical teams to develop test methods needed to ensure design requirements are sufficiently verified.
• Executes test protocols for clinically-based surgical simulation and automated testing utilizing robotic surgical systems and other test equipment.
• Identifies and presents problems that arise during feasibility and design verification testing, and escalates new or persistent failure modes to appropriate engineering teams.
• Collaborates with appropriate engineering teams on failure investigation and root cause analysis.
• Clearly documents test results and observations in test reports.

Test Fixture Development:

• Designs test fixtures and other test aids needed to perform Design Verification and Life/Reliability tests.
• Identifies processes and test methods that could benefit from new or updated fixture designs.
• Works with other engineers to develop concepts and approaches to fixture design.
• Responsible for documentation of fixtures utilizing SolidWorks and release of documents into Agile.

Other Responsibilities:

• Effectively translates functional requirements into appropriate acceptance criteria for test cases and test methods.
• Trains test technicians on test methods and procedures.
• Ensures successful, on-time completion of department projects and communicates constraints to direct management when project completion is at risk.
• Complies with Department and Standard Operating Procedures.
• Verifies and ensures adequate supply of test articles and other equipment or material.

Required Skills and Experience: Technical Skills:

• Familiarity with equipment needed to perform typical performance measurements on electro-mechanical systems.
• Basic knowledge of electrical systems, test equipment, and test practices is desirable.
• Experience using tools and measuring equipment (Force Gauge, Calipers, Instron, Oscilloscopes, etc.).
• Ability to perform basic mechanical engineering calculations needed to support equipment design, including dimensional analysis.
• Experience with MATLAB, Python, and Arduino is a plus.
• Experience with SolidWorks or similar CAD software is highly preferred.

Other Skills and Abilities:

• Proactive and self-motivated engineer.
• Quick learner with the ability to understand complex products and processes.
• Ability to work in a team environment.
• Ability to work independently and with minimal supervision.
• Ability to multitask and handle tasks with competing priorities effectively.
• Ability to work with biological samples, including blood, tissue, and organs.
• Familiar with GDP.

Integrity:

• Accepting and adhering to high ethical, moral, and personal values in decisions, communications, actions, and when dealing with others.

Required Education and Training:

• Minimum BS in Mechanical Engineering, Biomedical Engineering, or similar degree.
• Minimum 2+ years of work experience in an engineering organization or research team environment.

Working Conditions:

• Time is spent at a desk in front of a computer as well as working in a lab environment.
• Lab environment will have exposure to animal blood and tissue, as well as exposure to detergents and other chemicals used for reprocessing medical devices.
• Hands-on testing includes using robotic systems, mechanical test fixtures, microscopes, and electrical test fixtures.

Preferred Skills and Experience:

• Experience within the medical device or pharmaceutical industry is preferred.
• Experience working with electro-mechanical systems is a plus.