This role is an entry-level engineering role on the Affera Hardware Product Quality team. The team is responsible for full life-cycle support of the Capital equipment and accessories of the Affera system, including design qualification (DV and DVal), risk management, design change assessment, supplier change support, and risk response for commercial product. This role will support execution of deliverables across several simultaneous change efforts to maintain patient safety, compliance, and reliability. 

Electrical, Electronics, or Computer engineering backgrounds are preferred. 

Primary Responsibilities 

• 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. 

Required Qualifications 

• Bachelor's degree and a minimum of 0 years of relevant experience
   

Preferred Qualifications 

• Electrical, Electronics, or Computer engineering backgrounds are preferred 

• Medical Device Experience 

• Knowledge of design qualification (DV and DVal)