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Reliability Engineer

LanceSoft Inc.
Mounds View, Minnesota, United States
November 05, 2018


Job Title: Sr Reliability Engineer

Location: Mounds View, MN

Duration: 06+Months (possibilities of extension or conversion)

Top Requirements:

• Experience with risk management (Hazards/Harms, and DFMEAs)

• Some statistics knowledge (able to perform reliability time to failure analysis such as Weibull, Kaplan Meier, and Binomial)

Position Description:

• Understand product function, use environments, and performance to appropriately and strategically apply technical knowledge, reliability tools, and reliability methodologies to assess the impact of proposed reliability enhancements

• Plan, lead, and execute test and assessment activities, to demonstrate product performance and compliance

• Perform systematic reliability analysis against requirements, through the appropriate application of reliability engineering and risk management techniques (e.g. FMEA, failure trending and analysis, reliability forecasting, etc.).

• Lead cross-functional teams in the preparation of Reliability and Patient Safety Risk Assessments, including issue triages for CAPAs, reliability predictions, Hazard Analyses, etc.

• Review and approve manufacturing and design changes and assess their impact in order to ensure reliability requirements are met

• Maintain risk management and compliance documentation

• Communicate to key stakeholders, including external regulatory agencies, regarding fielded product with potential quality issues

• Provide support to internal and external audits

Education required:

• Bachelor’s degree in Engineering or technical field

Minimum required years of experience :

• 4+ years’ experience in medical technology with Bachelor’s; 2+ years with Master’s degree in Engineering or technical field

Desired/Preferred Qualifications:

• Proficiency with data analysis using reliability tools and statistical techniques

• Experience in a highly regulated industry, preferably medical devices

• Experience with solving complex issues by interacting with cross functional groups

• Proven ability to operate in a matrix organization and navigate complex business systems, regulations, standards, and performance requirements

• Knowledge of reliability tools and practices that effectively support requirements, design, integration and verification, and validation

• Demonstrated critical thinking skills with focus on improved system performance outcomes and positive business impact

• Demonstrated ability to leverage data and apply knowledge to drive process and product improvement

• Excellent problem solving skills, including demonstrated application of structured problem solving methods and tools

• Understanding of Left Ventricular Assist Devices (LVAD) and their use in the clinical environment

• Reliability engineering experience, including product performance modeling and trending

• Knowledge of cardiac anatomy, physiology, primary disease states

• Strong written and oral communication skills (timely, clear, concise, accurate, conclusive, influential, targeted to audience)

• Strong collaboration and influence skills (build relationships, leverage others, align and work towards shared outcome-based goals, understand others’ needs, negotiate for win-win, own the whole).

• Experience working across geographies and cultures

• Experience with 21 CFR Part 820 (Quality System Regulation), 21 CFR 803 (Medical Device Reporting), 21 CFR 806 (Corrections/Removals), ISO 13485, etc.

• Experience with the application Risk Management in medical devices (ISO 14971)

• Knowledge of project management tools and techniques

• Experience working across geographies and cultures