Design Assurance Engineer II

Abbott; Plymouth (MN); On-site; USD 61,300 - 122,700; Full time

Job summary

Abbott in Plymouth, MN seeks a Design Assurance Engineer II to lead development projects and ensure design verification/validation for medical devices. The role requires coordinating cross‑functional teams and aligning outputs to regulatory expectations and production controls.

Responsibilities include establishing verification strategies, leveraging statistics, and supporting audits and re‑certifications while maintaining DHF integrity and compliance with FDA regulations.

Qualifications

• Bachelor’s degree in Engineering or a Technical Field; advanced degree preferred.
• Experience with design verification/validation in medical devices.
• Familiarity with regulatory standards (FDA, GMP, ISO 13485).
• Knowledge of statistical methods and software (Minitab).
• Ability to travel up to 5–10%, including international.

Responsibilities

• Lead complex development projects and quality improvement initiatives.
• Set cross‑functional strategies and drive compliant, efficient solutions.
• Develop and execute design verification/validation strategies with emphasis on controls.

Skills

Design verification

Design validation

Applied statistics

Minitab

Regulatory compliance

Cross-functional collaboration

Education

Bachelor’s degree in engineering or technical field

Advanced degree in Biomedical/Mechanical Engineering preferred

Tools

FDA/ISO standards knowledge

Job description

Design Assurance Engineer II – Plymouth, MN

Responsibilities

• Lead and implement complex development projects including quality improvement initiatives.
• Set strategies for cross‑functional teams and drive toward compliant and efficient solutions to complex problems.
• Execute on holistic and strategic design verification/validation strategies with emphasis on:
  • Technical analysis of requirements, specifications, and control strategy
  • Efficient and cost‑effective execution of validation and verification
  • Alignment of design outputs to production and process controls
  • Proper verification techniques including inspection, demonstration, test, etc.
• Lead design characterization activities for development projects.
• Influence design and verification decisions through the use of applied statistics.
• Support design test and inspection method development, and lead method validation activities.
• Ensure DHF content integrity, completeness, and regulatory standards compliance; collaborate to communicate and resolve gaps.
• Support and ensure internal and external audit responses and on‑time product re‑certifications.
• Support the establishment of objective, measurable, discrete, and verifiable customer and product requirements.
• Support all company initiatives identified by management and in support of QMS, EMS, and other regulatory requirements.
• Comply with U.S. FDA regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments, maintaining positive and cooperative communication with all levels of employees, customers, contractors, and vendors.
• Perform related duties and responsibilities as assigned.

Qualifications

• Bachelor’s degree in Engineering or a Technical Field; advanced degree in Biomedical Engineering or Mechanical Engineering preferred.
• 2–3 years of engineering experience in new product development.
• Strong knowledge of design verification and design validation techniques.
• Working knowledge of applied statistics, sampling strategies, and design of experiments, including statistical software such as Minitab.
• Strong organizational and follow‑up skills, with attention to detail.
• Ability to collaborate on‑site on a regular basis.
• Ability to travel up to 5–10%, including internationally.
• Knowledge of FDA, GMP, ISO 13485, IEC 60601, ISO 14971.
• Prior medical device experience, especially electrophysiology or cardiovascular devices preferred.
• ASQ certification (CQE, CQA) or similar is a plus.

Abbott is an Equal Opportunity Employer, committed to employee diversity.

Base pay range: $61,300.00 – $122,700.00.