Design Quality Engineer

Infotree Global Solutions; Minneapolis (MN); On-site; USD 90,000 - 120,000; Full time

Job summary

Infotree Global Solutions in Minneapolis is seeking an experienced Reliability Engineer for a 12+ month contract in the medical device sector. You will design, validate and improve product reliability through formal analysis and testing.

Responsibilities include conducting reliability studies and DOE, performing risk analyses, analyzing data and statistics, and ensuring documentation meets regulatory requirements.

Qualifications

• Must have experience in design assurance, design quality and reliability in medical devices.
• Experience with quality systems and regulatory compliance is preferred.

Responsibilities

• Develops, coordinates and conducts technical reliability studies and DOE constructs.
• Recommends design or test methods and SPC procedures to achieve product reliability.
• Completes risk analysis studies of new design and processes.
• Analyzes performance data and control statistics to identify reliability risks.
• Ensures corrective actions meet reliability standards and documentation complies with requirements.
• Develops reliability programs to meet objectives.
• May develop mathematical models to identify high-risk units or processes.
• Collaborates with engineering and manufacturing to maintain quality standards.
• Designs inspection and testing mechanisms and conducts QA tests; analyzes costs of non-conforming products.

Skills

Design Assurance

Design Quality

Reliability

Medical device quality experience

Job description

Location :Minneapolis Minnesota 55432

Contract 12+ Months

Job Description:

Technical Skills

Must Have

• Design Assurance/Design Quality/Reliability
• General quality experience in med device

Nice To Have

• self-driven, independent ability to engage with cross functional teams and manage multiple project workload

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 and that documentation is compliant with requirements.
• 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.
• May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.
• Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.
• Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
• Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.