Design Assurance Quality Engineer II

Abbott; Saint Paul (MN); On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

Medical plan

Dental plan

Vision plan

Health Savings Account

401(k)

Job summary

Abbott is seeking a Design Assurance Quality Engineer II to ensure new or modified medical device products meet requirements and quality system standards. The role supports development, manufacturing, and cross-functional teams to protect patient safety and align with business needs in the Vascular division.

You will lead Design Assurance deliverables, support risk management, and assist design verification/validation, process validation, and CAPA activities in a fast-paced, onsite setting at

Qualifications

• Bachelor’s degree in Engineering and 2+ years of engineering experience with quality tools/methodologies.
• Experience with design control, risk management, and regulatory compliance is required.
• Excellent communication and teamwork across matrixed, global teams.

Responsibilities

• Lead on-time completion of Design Assurance deliverables.
• Support definition of customer and product requirements.
• Lead risk management activities from concept through commercialization.

Skills

Quality tools/methodologies

Strong communication

Cross-functional collaboration

Problem solving

Adaptability

Education

Bachelor’s degree in Engineering

Advanced degree in Mechanical or Biomedical Engineering

Tools

CAPA process

Risk management tools

Job description

Job Title: Design Assurance Quality Engineer II

Location: St Paul, MN75038

Duration: 6 Months

Work Arrangement: 100% Onsite

The Opportunity

This position works out of our New Brighton, MN (AVSP) location in the Vascular division. Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of Vascular disease.

The individual in this position will assure new or modified products conform to requirements and establish compliance with the quality system.This position is responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs.This position will support new product development projects as well as support sustainability of commercially released product. This position will also support manufacturing processes to meet daily production schedules while enhancing productivity and product quality.

Primary Responsibilities:

• Lead on-time completion of project supported Design Assurance deliverables and business initiatives.
• Support the definition of objective, measurable, discrete, and verifiable customer requirements, external requirements, and product requirements.
• Lead Risk Management activities from product Concept through Commercialization, including analyzing field data to support new product development, and support Failure Mode Effects Analysis.
• Support Test and Inspection Method development including Method Validation activities.
• Support Design Verification and Design Validation planning and execution, including cross-functional root-cause analysis investigation and resolution activities.
• Support manufacturing process development and qualification for new product commercialization and product changes.
• Accountable for Process Validation planning and execution, including active cross-functional root-cause analysis investigation and resolution activities.
• Identify and implement effective Process Control and monitoring of CTQ parameters and specifications.
• Support, review, and approve Document Change Order and CAPA records in a timely and objective manner.
• Support product builds in the cleanroom for development and commercial activities.
• Maintain high standards for Device History File (DHF) content completion, integrity, and regulatory / standards compliance; collaboratively identifying, communicating, and resolving gaps.
• Be innovative, resourceful, and work with minimal direction. Have excellent organization, problem solving, communication, and team leadership skills. Work effectively with cross-functional teams.
• Build strong collaborative partnerships with cross functional teams including Program Management, Research & Development, and Process Development to ensure cross functional customer needs are met without creating barriers to development cost, time, and scope.
• Collaborate with suppliers to drive and implement appropriate changes identified during product development.

Required Qualifications:

• Bachelor’s degree within an Engineering field or a closely related discipline.
• 2+ years of engineering experience and demonstrated use of Quality tools/methodologies.
• Solid verbal, written, and interpersonal skills with ability to effectively communicate at multiple levels in the organization.
• Ability to work in a highly matrixed and geographically diverse business environment.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• Ability to leverage and/or engage others to accomplish projects.
• Multitasks, prioritizes and meets deadlines in timely manner.
• Strong organizational and follow-up skills, as well as attention to detail.
• Ability to travel occasionally (<10%), including internationally.

Preferred Qualifications:

• Bachelor’s or advanced degree in Mechanical or Biomedical Engineering
• Medical device experience in development or manufacturing or other Cardiovascular catheter device development/manufacturing strongly preferred.
• Familiar with 21 CFR Part 820, ISO 13485, ISO 14971, EUMDR, and MDSAP.

Other Responsibilities:

• Support and ensure internal & external audit responses and on-time product re-certifications.
• Writes and revises SOPs, controlled forms, and related documents to ensure best practices and maintain compliance.
• Participate in Corrective Action/Preventive Action (CAPA) process including the investigation of failures or deviations, as required.
• Additional duties may be identified by functional management based on current project/business objectives.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
• Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.

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.