Verification and Validation Lead

at  Vital Bio

About You: You possess excellent problem-solving skills and approach every problem with a friendly and positive attitude. You are self-motivated and have a high level of autonomy and enjoy working in a highly technical, fast-paced, multidisciplinary environment. You take ownership of a problem and seek additional information where sufficient input is lacking to proceed with testing and see the problem through to resolution. You take pride in making things work and seeing others effectively use what you worked on.
What You’ll Do: Take ownership of various design verification and validation activities; Work closely with the R&D and engineering teams to comprehend and scrutinize complex hardware and system-level requirements; Lead a team of engineers and technicians to design, develop, and execute test procedures; Complete documentation for results and reports to be submitted to regulatory bodies; Use exploratory test techniques to provide early testing feedback throughout the design and development process; Design and develop methods and test tools, manual and automated, to aid in efficient and systematic testing; Demonstrated use of reliability and quality engineering methods and tools - DFMEA, life data analysis, reliability testing, statistical analyses, etc; Participate in the assessment of potential product hazards and devise appropriate tests to verify mitigation of identified risks; Participate in design reviews to discuss implementation details and suggest improvements/features; Accurately report and track product defects, verify hardware bug fixes, and perform regression testing; Assist with the process of transferring the design to manufacturing; Help generate manufacturing instructions and associated in-process test methods; Manage test equipment to comply with calibration requirements and perform inspection on equipment. What You’ll Need: Bachelor’s or Master’s degree in Electrical Engineering, Mechatronics Engineering, Biomedical Engineering or equivalent; 10+ years of related experience; 2+ years of professional experience in a team working on new product development; Experience in a regulated industry (specifically medical, automotive, aerospace); Hands-on expertise with electrical test and measurement equipment: oscilloscopes (voltage/current/power), multimeters, signal generators, optical systems, computer vision, machine learning; Advanced level analytical programming (Python, Matlab, etc). Bonus points for: Experience developing/testing/production of IVD devices; Experience designing specialized electro-mechanical and optomechanical test fixtures; Scripted automated testing (e.g. using Python or JavaScript with Test and Measurement equipment); Familiarity with CAD software (SolidWorks), prototyping equipment (CNC, 3D printing, laser cutter), and general machine shop experience; Knowledge of the following standards: IEC 60601, ISO 13485, ISO 14971; Experience with the medical device product development lifecycle; Appreciation of puns

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