TÜV Rheinland North America · 8 hours ago
Senior Test Engineer, Medical
Pleasanton, CA
Full-time
Onsite
Senior Level
$105K/yr - $115K/yr
7+ years expTÜV Rheinland North America is one of the world’s leading testing, inspection, and certification service providers. The Senior Test Engineer is responsible for regulatory compliance testing and reporting of medical device products, developing test procedures, and leading other engineers in compliance activities.
Public Safety
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
Qualification
Required
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)
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
Preferred
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
Benefits
Multiple health insurance plan options
401(k) with up to 6% company match
Company
TÜV Rheinland North America
TÜV Rheinland is a world leader in testing, inspection and certification services for a wide variety of industries.
501-1000 employees
Funding
Current Stage
Late StageLeadership Team
Christine Menchaca
Senior Human Resources Business Partner
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