Development Quality Engineer II

Abbott; Minneapolis (MN); On-site; USD 66,000 - 115,000; Full time

Job summary

A global healthcare leader, Abbott, is hiring a Development Quality Engineer II in Minneapolis. The successful candidate will be responsible for leading quality activities involving Capital Equipment, Electrical Design, and Software Development. Excellent experience in Medical Device engineering and working knowledge of FDA regulations is required. This position offers an engaging opportunity to collaborate on innovative projects in a dynamic environment.

Benefits

Medical and Prescription Drug Plans

Dental Plan

Vision Plan

Health Savings Account

Flexible Spending Accounts

Supplemental Life Insurance

Short Term Disability

Long Term Disability

401(k)

Qualifications

• 3-5+ years of Medical Device engineering experience.
• Experience in supplier controls and tracking design outputs.
• Working knowledge of design verification and validation techniques.

Responsibilities

• Lead design verification/validation strategies.
• Support design test and inspection method development.
• Ensure alignment of design outputs to production controls.

Skills

Attention to detail

Organizational skills

Collaborative skills

Working knowledge of FDA guidelines

Working knowledge of IEC 60601

Statistical software tools (like Minitab)

Education

Bachelor level degree in Engineering

Advanced degree in Biomedical Engineering

Advanced degree in Electrical Engineering

Advanced degree in Computer Science

Job description

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• Capital Equipment, Electrical Design, and Software Development quality activities
• Execute Design Verification/Validation Strategies with emphasis on:
• Technical analysis of requirements, specifications, and control strategy
• Alignment of design outputs to production and process controls
• Support design test and inspection method development, and lead method validation activities.
  
  

Title: Development Quality Engineer II

Location: Plymouth, MN

Duration: 7 Months

100% onsite

Responsibilities

Job description

• Capital Equipment, Electrical Design, and Software Development quality activities
• Execute Design Verification/Validation Strategies with emphasis on:
• Technical analysis of requirements, specifications, and control strategy
• Alignment of design outputs to production and process controls
• Proper verification techniques including inspection, demonstration, test, etc.
• Lead design characterization activities for development projects
• Support design test and inspection method development, and lead method validation activities.
  
  

Qualifications

• Bachelor level degree in Engineering or Technical Field; advanced degree / Biomedical Engineering / Electrical Engineering / Computer Science preferred.
• 3-5+ years Medical Device engineering experience with new product development
• Experience in supplier controls, critical quality attributes, and tracing design outputs to implemented supplier processes.
• Working knowledge on design verification and design validation techniques.
• Working knowledge of applied statistics, sampling strategies, and design of experiments, including statistical software tools such as Minitab.
• Strong organizational and follow-up skills, as well as attention to detail
• Ability to collaborate on-site on a regular basis.
• Knowledge of FDA, IEC 60601, GMP, ISO 13485, and ISO 14971
• Prior medical device experience preferred
  
  

Consultants Eligible Benefits Upon Waiting Period

• Medical and Prescription Drug Plans
• Dental Plan
• Vision Plan
• Health Savings Account (for High Deductible Health Plans)
• Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit)
• Supplemental Life Insurance
• Short Term Disability (coverage varies by state)
• Long Term Disability
• Critical Illness, Hospital coverage, Accident Insurance
• MetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance
• 401(k)
  
  

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional and branded generic medicines.

Working together, Abbott and Talent Solutions partner to deliver top talent for contingent roles at Abbott, building better and healthier lives. Abbott believes all employees are essential to creating life-changing breakthroughs, performing key duties to create life-changing breakthroughs.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Job function

  Quality Assurance

• Industries

  Hospitals and Health Care

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