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We are looking for a dynamic and adaptive Reliability Engineer II, with the desire to be part of the fast-growing Surgical Innovationsbusiness, helping us to ensure they exceed the safety and reliability requirements and expectations of patients, clinicians, regulators, and the business. 
This position provides reliability engineering support on new development projects. The candidate will be a key player in cross-functional teams and serve as a compliance and technical representative for reliability, safety, and quality functions. 
As part of Quality project teams, the Reliability Engineer II will define, contribute, and execute the quality plan for ensuring compliance to regulatory requirements. This position will collaborate with multidisciplinary teams and provide guidance to technical issues, guidance to external supplier remediation, engagement in design and risk reviews, and contribute to development activities.

The Reliability Engineer II position on the team supports new product development for various product families in the Surgical Innovations Business. In this role, the Reliability Engineer II works as part of the quality team supporting the cross-functional core team. The Reliability Engineer develops, coordinates, and conducts technical reliability studies and evaluations of engineering design concepts and design of experiments (DOE) constructs; Recommends design or test methods and statistical process control procedures for achieving required levels of product reliability;Completes risk analysis studies of new design and processes; Compiles and analyzes performance reports and process control statistics; investigates and analyzes relevant variables.

potentially affecting product and processes; Ensures that corrective measures meet acceptable reliability standards; Analyzes preliminary plans and develops reliability engineering programs to achieve company, customer, and governmental agency reliability objectives; May develop mathematical models to identify units, batches or processes posing excessive failure risks.As necessary, proposes changes in design or formulation to improve system and/or process reliability; And may determine units and/or batches requiring environmental testing, and specifies minimum number of samples to obtain statistically valid data.

In addition, Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product, Collaborates with engineering and manufacturing functions to ensure quality standards are in place, Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment, Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.Ensures that corrective measures meet acceptable reliability standards, and that documentation is compliant with requirements.

• Bachelors degree required
• Minimum of 2 years of relevant experience, or advanced degree with 0 years of experience

·Knowledge and experience in developing and manufacturing medical devices in conformance with Quality System Regulations, ISO9001, 13485, and 14971 requirements.

·Knowledge of Reliability Testing and development, analytical tools, and methods, including Statistical Quality Control/Statistical Process Control (Minitab preferred), Design Of Experiments (DOE) and the use of computer/software packages related to reliability, design, development, and manufacturing.

·ASQ Certified Reliability Engineering (CRE) and/or Quality Engineering (CQE), or Certified Quality Auditor (CQA)

·Six Sigma Green belt or Black Belt certified

·Experience in a regulated environment (FDA, ISO, etc.)

·Experience working in a regulated industry with knowledge of common applicable standards for ablation systems like 60601-1 (electrical safety), 14971 (risk mgmt.) and 10555 (intravascular catheters).

·Strong understanding and experience in the application of statistics.

·Excellent organizational and communication (oral and written) skills. Ability to work on teams as well as individually. Able to set and meet goals. Organized and detail oriented. Problem solving and analysis skills.

·Ability to work in a fast-paced environment; Ability to work well under pressure and maintain positive, enthusiastic attitude.

·Strong attention to detail and accuracy. Ability to successfully balance and prioritize multiple ongoing projects/tasks (Project Management skills).

·High degree of initiative and self-motivation.Strong analytical skills and the ability to solve problems through analytical reasoning.

·Good interpersonal skills: Ability to work effectively in a team environment and build strong working relationships. Effective communication skills, both written and oral and must be computer literate.