V&V Engineer

About You:

You possess excellent problem-solving skills and approach every problem with a friendly and positive attitude. You are self-motivated, possess a high level of autonomy, and enjoy working in a highly technical, fast-paced, and 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 activities;

• Design, develop, and execute test plans and procedures;

• Work closely with the R&D, Engineering, and Quality teams to create a robust test suite;

• Complete documentation for results and reports;

• 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 design reviews to assess design verification and validation impact;

• Accurately report and track product defects, verify hardware bug fixes, and perform regression testing;

• Help generate manufacturing instructions and associated in-process test methods, where necessary;

• 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;

• 3+ years of related experience;

• 2+ years of professional experience in a team working on new product development;

• Experience in a regulated industry (specifically medical and 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!