Electrical Quality Engineer II

Title: Development Quality Engineer II

Location: Plymouth, MN

Duration: 12 Months

100% Onsite

Basic Qualifications:

• Bachelor’s degree in Engineering or Technical Field.
• Experience in R&D, Process/Manufacturing Engineering, and/or Quality with at least 2 years supporting product development.
• Experience in medical devices and associated regulations/standards.
• Experience in test method development and validation
• Experience in preparing risk assessments, FMEA and other risk documents.

Duties:

• Lead and support Risk Management activities, specifically on devices with Electrical Design and Software Capabilities.
• Risk Management activities will be from product concept through commercialization, including generation of risk management plans/reports, completion and maintenance of hazard analysis, Design FMEAs, and, Software FMEAs.
• Participate in or lead teams in supporting quality disciplines, decisions, and practices, lead on-time completions of design control deliverables
• Lead identification of essential outputs and generate Essential Output reports
• Lead efforts in support of software verification compliance to standards such as 62304
• Support on-time execution of Quality Plans for internal product development process (PDP), OEM-based Clinical Product Development (CPDP) and design change projects,
• Accountable for generation of PDP design verification test plans/reports for product/system requirements
• Work with design engineering in the completion of customer/system/product requirements
• Work with design engineering in the completion of product verification and validation
• Support the development, qualification and on-going manufacturing of products to meet or exceed internal and external requirements
• Support all company initiatives as identified by management and in support of quality management systems (QMS), Environmental Management Systems (EMS) and other regulatory requirements, additional duties may be identified by functional management based on the current project/business objectives.

Years Experience:

• 3 - 5 years

Skills:

• Verbal and written communication, interpersonal, team work, individual contributor, multi task, strong organizational, advanced computer skills

Education:

• Bachelor level degree in an Engineering Discipline or Technical Field with medical device experience

Preferred Qualifications:

• Advanced Degree in Engineering/Technical Field
• Experience in active implantable medical devices.
• Knowledge of requirements management tools (e.g., JAMA) and use of problem reporting systems (e.g., JIRA).
• Working knowledge of statistics and its application to verification and validation

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.