Can you please confirm your top 3 skills sets required? critical thinking, knowledge of quality management systems, knowledge of risk management processes Can you please confirm the 3 main responsibilities/day to day activities required for this role? software reliability testing, software reliability FMEA (failure mode effects analysis), GSPR (general safety performance requirements) What products (if any) will this role support? primarily cloud software products, but may include other products What is your target years of experience? 0 - 5

desired skills (nice to have):

• Critical thinking and problem-solving skills, including application of structured problem-solving methods and tools.

• Written and oral communication skills, including the ability to summarize complex technical concepts and problems clearly and concisely.

• collaboration and influence skills.

• Advanced degree in engineering, science, or equivalent field.

• Exposure to or experience working in or with Design, Quality, Regulatory, Clinical and/or Manufacturing.

• Certified Reliability Engineer (CRE), Certified Software Quality Engineers (CSQE) or equivalent certification.

• Experience in the application of Risk Management (ISO 14971) and hazard analysis and risk analysis techniques (e.g., PHA, HA, FTA, DFMEA).

• Experience with Software Reliability Engineering models including growth models.

• Ability to independently lead investigations to identify system/product failures, hazards, hazardous situations, and harms.

• Experience in the design, maintenance, or continuation engineering of released software or software systems, including mobile applications.

• Experience with automated and/or manual software tests.

• Experience with Agile or behavior-based development.

• Experience in medical devices or other regulated industry.

• Experience with 21 CFR Part 820 (Quality System Regulation), ISO 13485, etc.

• Experience working with IEC 62304.

• Knowledge of Design for Six Sigma (DFSS), Design for Lean Sigma (DFLS), Design for Reliability and Manufacturability (DRM), or other robust design practices.

• understanding of and experience in the application of statistics, including experience with Minitab.

Template/Generic JD: Responsibilities may include the following and other duties may be assigned. 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. May determine units and/or batches requiring environmental testing, and specifies minimum number of samples to obtain statistically valid data.

SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

DIFFERENTIATING FACTORS

Autonomy: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments.

Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones . May have some involvement in cross functional assignments.

Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex . Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.

Communication and Influence: Communicates primarily and frequently with internal contacts . External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decisionmaking.

Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream.

Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 2 years of relevant experience

Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.

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