As a senior hardware test engineer you will be responsible for generating verification test plans, executing test protocols as well as creating and managing design input requirements for our state of the art surgical robotics platform. You will have lead role in the Hardware Test Engineering team where you will mentor junior staff members and provide leadership to continuously improve hardware testing processes and procedures. You will have the opportunity to work with a highly talented team to develop new products in the rapidly growing orthopedic robotic surgery market.
ESSENTIAL FUNCTIONS: -
Develop verification test plans for new and revised orthopedic surgical robotic products.
Create design input requirements for new product development activities with an emphasis on ensuring that requirements are clear and testable.
Develop test cases that adequately depict the methods and techniques necessary to examine or validate our medical device designs to related standards as developed by external regulatory groups such as ISO, IEC, FDA, etc.
Develop and implement test methods to conduct Verification Tests of medical devices and accessories; select test equipment, supplies, evaluation of designs.
Review appropriate or mandated agency specifications and structure device test cases in accordance with required specifications.
Write sub system level and system level test protocols and reports
Work on project teams and collaborate with team members to ensure project timelines are met
Document test results with formal Engineering Reports
Participate in design reviews as required
Provide guidance/direction to Test Technicians and junior engineers.
Experience in verification and validation testing of electromechanical device
Test experience as related to new product development and sustaining products
QUALIFICATIONS, KNOWLEDGE AND SKILLS REQUIRED:-
Able to read and interpret CAD Drawings to component level.
Proficient with common software packages (such as MS Office, spreadsheets, presentations, etc.)
Must be detail-oriented with strong data analytic, written and oral communication skills.
Strong Statistical Analysis skills required such as Gage R&R study, Design of Experiments (DOE), Probability Distribution, etc.
Minimum Bachelors of Science in Electrical Engineering, Mechanical Engineering or related major. Minimum of 5 years of product testing experience required.
Advance Degree Preferred.
Test Engineering experience, including design, documentation, and validation of test systems and Hardware is required.
Fundamental knowledge of programming instrumentation and hardware used in testing of electrical subassemblies and devices.
Design Control experience from a regulated industry such as Medical Device, Pharmaceuticals.
Labview experience is preferred.
Associated topics: compliance, h/w test, hardware test, prove, qa, quality assurance, test engineer, test hardware, troubleshoot, verify
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.