Design Assurance Engineer

Duties:

• 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.

Must Haves:

• 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.
• Experience with Software Design Assurance, including risk management documentation, traceability matrixes, GSPR, reliability testing

Nice to Have:

• 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 with Change Impact Assessments to determine risk to the product from planned changes
• 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.