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
Additional product Reliability responsibilities may be included, primarily focused on Affera Capital (HW) equipment DRM, change management, risk management, and risk response

Bachelor's degree and a minimum of 4 years of relevant experience OR Master’s degree with a minimum of 2 years of relevant experience OR PhD with 0 years relevant experience
Thorough understanding and experience in design controls, V&V, and Risk Management
both commercial and development
System-thinking and process mapping, ability to effectively identify interfaces, dependencies, and control points
Demonstrated ability in stakeholder management and coordinating complex assignments with cross-functional teams
Understanding of 21CFR820, ISO13485, and ISO14971 Medical Device Experience
Electrical / Electronic Experience

Health, Dental and vision insurance
Health Savings Account
Healthcare Flexible Spending Account
Life insurance
Long-term disability leave
Dependent daycare spending account
Tuition assistance/reimbursement
Simple Steps (global well-being program)
Incentive plans
401(k) plan plus employer contribution and match
Short-term disability
Paid time off
Paid holidays
Employee Stock Purchase Plan
Employee Assistance Program
Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)

Senior Reliability Engineer – Hardware, Electrical

Key skills