Senior Test Engineer, Medical

TUV Rheinland of North America•Pleasanton, CA

About The Position

Joining TÜV Rheinland means working for one of the world’s leading testing, inspection, and certification service providers with more than 25,000 employees globally. Our employees are our most important asset. That is why we invest in their development and offer competitive pay, multiple health insurance plan options, and a 401(k) with up to 6% company match. At the same time, we live an international, team-oriented culture characterized by respect, collegiality and openness. This enables our employees to develop their potential, apply new knowledge and methods directly - and plan a long-term career with real opportunities for advancement. SUMMARY: A Senior Test Engineer is responsible for completing all aspects of regulatory compliance testing and reporting of medical device products. This includes developing and implementing test procedures for testing of components, subsystems, and medical device products. They have significant experience with core standards from IEC 60601 and IEC 61010. This position works closely with, and leads, other engineers to support compliance activities. Will work directly with lab management providing guidance and assisting with development of the lab.

Requirements

Ability to work in a team environment and able to take direction.
Advanced engineering knowledge, understanding of testing requirements, manufacturing processes, drawings and standards.
Excellent communication skills/friendly manner, to relay complex scientific and technical information in a clear, concise, and understandable manner, verbally and in technical writing.
Advanced analytical, problem solving and troubleshooting skills.
Knowledge of US and international regulatory standards and approval requirements.
Demonstrated knowledge of western consumer values and expectations regarding foreseeable product use and abuse.
Ability to work in a dynamic environment.
Ability to organize, prioritize and perform multiple tasks while meeting or exceeding deadlines.
Ability to travel. Valid driver’s license required.
Bachelor’s Degree in a technical discipline or equivalent education and/or experience in medical product safety testing.
Regulatory Testing training.
7 years minimum test experience and evaluating medical device products in accordance with product regulatory standards.
Direct experience with IEC 60601-1-6 (Usability), IEC 60601-1-8 (alarms), IEC 60601-1-11 (home healthcare), IEC 60601-2-2 (high frequency surgical), IEC60601-2-18 (endoscopy), IEC60601-2-22, IEC60601-2-34 (invasive blood pressure monitoring).

Nice To Haves

Additional experience with IEC 60601 collaterals and particulars is desirable.
Experience using automated test tools.
Experience testing to NEC, NFPA, UL, CSA, IEC, EN Standards preferred.

Responsibilities

Act as lead engineer on complex projects. Participate in setting technical direction; plan schedule and coordinate detailed phases of a project. May train other test engineers and test technicians.
Must have significant experience and be able to apply the requirements of medical product safety standards IEC 60601 and IEC 61010, with knowledge of the collaterals and particulars.
Conduct applicable testing to ensure products meet regulatory compliance requirements.
Perform thorough evaluation, testing and reporting of medical device products.
Understanding and familiarity of ISO 14971 Risk Management Process, IEC 60601-1-6 and IEC 62366 Usability Engineering Process and IEC 62304 Medical Device Software – Software life cycle processes.
May assist with defining customer technical requirements, scope, test strategies and selecting test equipment to prepare quotes and proposals.
Establish and maintain professional relationships with customers both internal and external. Consult with customer on highly complex issues.
Liaise with other global laboratories to ensure consistency and accuracy of methods and interpretations.
Document test results for corrective action, report and audits. Analyze test data and determine expected outcome for tests. Identify and report all deviations.
Must have knowledge of CB requirements such as OD-2044, OD-2048, OD-5010, OD-5013, OD-5014 etc.
Able to perform and participate with proficiency testing.
Maintain confidentially of all TUV and client information.
Perform other duties as assigned.