Associate Quality Engineer - Medical Device (Entry/Junior Level) - Planet Pharma : Job Details

Our client, a leading Medical Device company in Minneapolis, is seeking an entry/junior level Quality Engineer for their Cardiac Surgery product team - the ideal candidate is local to the Minneapolis area with a recent Bachelor's Degree within an Engineering realm (and ideally some medical device knowledge/experience). See below for other details!

Please Note: This is an onsite role in Minneapolis - please only apply if you are either local to the area or plan to relocate there.

Main Duties:

• DFMEA review/updates
• Project document reviews as the Quality representative

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.
• Responsible for executing test method validation.

Requirements:

• Bachelor's Degree in Engineering, Science or technical field with 0+ years of work experience in Engineering and/or Quality.

• Entry level

• Contract

• Quality Engineering

• Biotechnology Research and Medical Equipment Manufacturing