Senior Development Quality Engineer - Medical Devices

Abbott; Plymouth (MN); On-site; USD 78,000 - 156,000; Full time

Benefits offered by this job

Free HIP PPO coverage

Great retirement plan

Tuition reimbursement

Education benefits

Global company

Job summary

Abbott in Plymouth, MN is seeking a Senior Engineer to provide development and sustaining support within the Electrophysiology division. You will lead a multidisciplinary team from concept through launch, focusing on disposable catheter projects and design controls for complex medical devices.

The role emphasizes designing verification/validation strategies, applying statistics, and driving root-cause investigations.

Qualifications

• Bachelor degree in Engineering or Technical Field.
• Minimum of 6 years engineering experience with new product development.
• 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.
• Ability to travel approximately 10%, including internationally.
• Knowledge of FDA, IEC 60601, GMP, ISO 13485, and ISO 14971.
• Prior medical device experience preferred.

Responsibilities

• Be a core team member to implement complex development projects including quality improvement initiatives.
• Sets strategies for cross-functional teams and drives towards compliant and efficient solutions to complex problems.
• Train and develop other lower-level engineers.
• Execute on Holistic & 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 use of applied statistics.
• Support design test and inspection method development, and lead method validation activities.
• Lead root cause investigations, including corrective and preventive action activities, with the purpose of identifying the underlying issues and offering efficient long-term solutions.
• Ensure DHF content integrity, completeness, and regulatory / standards compliance; collaboratively communicating & resolving gaps.
• Serve as a front-room representative during internal and external inspections and inquiries from regulators such as FDA and ISO as it relates to design assurance.
• Support and ensure the establishment of objective, measurable, discrete, and verifiable customer and product 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.
• Complies with 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.
• Performs other related duties and responsibilities, on occasion, as assigned.

Skills

Critical thinkers

Collaborators

Problem Solvers

Communicators

Responsible

Education

Bachelor level degree in Engineering or Technical Field

Tools

Minitab

Job description

Abbott in Plymouth, MN is seeking a Senior Engineer to provide development and sustaining support within the Electrophysiology division. You will lead a multidisciplinary team from concept through launch, focusing on disposable catheter projects and design controls for complex medical devices.

The role emphasizes designing verification/validation strategies, applying statistics, and driving root-cause investigations.