Abbott
Join to apply for the
Development Quality Engineer II
role at
Abbott .
Title:
Development Quality Engineer II Location:
Plymouth, MN Duration:
12 Months
Responsibilities
Lead and support Risk Management activities on devices with Electrical Design and Software Capabilities from product concept through commercialization.
Generate and maintain risk management plans/reports, hazard analysis, Design FMEAs, and Software FMEAs.
Participate in or lead teams supporting quality disciplines, decisions, and practices, ensuring on-time completion of design control deliverables.
Lead identification of essential outputs and generate Essential Output reports.
Lead efforts supporting 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 to complete customer/system/product requirements and verification/validation.
Support development, qualification, and ongoing manufacturing of products to meet or exceed internal and external requirements.
Support company initiatives in alignment with quality management systems (QMS), Environmental Management Systems (EMS), and regulatory requirements.
Duties
Lead and support Risk Management activities, specifically on devices with Electrical Design and Software Capabilities.
Risk Management activities 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 ongoing 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.
Skills
Verbal and written communication, interpersonal, teamwork, individual contributor, multitask, 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.
Benefits
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.
#J-18808-Ljbffr
Development Quality Engineer II
role at
Abbott .
Title:
Development Quality Engineer II Location:
Plymouth, MN Duration:
12 Months
Responsibilities
Lead and support Risk Management activities on devices with Electrical Design and Software Capabilities from product concept through commercialization.
Generate and maintain risk management plans/reports, hazard analysis, Design FMEAs, and Software FMEAs.
Participate in or lead teams supporting quality disciplines, decisions, and practices, ensuring on-time completion of design control deliverables.
Lead identification of essential outputs and generate Essential Output reports.
Lead efforts supporting 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 to complete customer/system/product requirements and verification/validation.
Support development, qualification, and ongoing manufacturing of products to meet or exceed internal and external requirements.
Support company initiatives in alignment with quality management systems (QMS), Environmental Management Systems (EMS), and regulatory requirements.
Duties
Lead and support Risk Management activities, specifically on devices with Electrical Design and Software Capabilities.
Risk Management activities 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 ongoing 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.
Skills
Verbal and written communication, interpersonal, teamwork, individual contributor, multitask, 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.
Benefits
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.
#J-18808-Ljbffr