Senior Design Assurance Engineer

Job Duties

SENIOR DESIGN ASSURANCE ENGINEER – St. Jude Medical, an Abbott Labs Co. / Plymouth, MN

Responsible for executing Holistic and Strategic Design Verification and Validation strategies focusing on customer needs and requirements. Maintain DHF, design input and design output, external requirements, and risk management documentation. Lead risk management meetings assessing the impact of product or supplier changes to risk profile. Lead and execute design verification and validation activities such as test planning and execution, and creation of protocols and reports. Interpret external standards and implement product requirements and testing to meet external standards. Ensure DHF content completion, integrity, and regulatory and standards compliance while collaboratively communicating and resolving gaps. Lead, design, test, and inspection method development validation activities. Lead root cause investigations, such as corrective and preventive action activities (CAPA), with the purpose of identifying the underlying issues and offering efficient long-term solutions. Ensure compliance with FDA, ISO 13485, ISO 14971, and internal Quality Management System (QMS) standards. 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. Work within a team, and independently, in a geographically diverse business environment. Serve as a resource in the selection, orientation, and training of new engineers and employees. Mentor employees by sharing technical expertise and providing feedback and guidance. Perform other duties and responsibilities as assigned by functional management based on the current project and business objectives.

Bachelor’s or foreign equivalent degree in Computer Science, Mechanical Engineering, Computer Engineering, or in a related field of study. Must possess at least 3 years of professional Engineering experience in: (i) executing Holistic and Strategic Design Verification and Validation strategies; (ii) leading, designing, testing, and inspection method development validation activities; (iii) ensuring compliance with FDA, ISO 13485, ISO 14971, and internal Quality Management System (QMS) standards; and (iv) working within a team, and independently, in a geographically diverse business.

An EOE. 40 hrs/wk. $108,451-$156,000/year. Send resumes to or by mail to Abbott Laboratories, Attn: 26J14A, Willis Tower, 233 S. Wacker Dr., Floor 26, Dept. 32, Chicago, IL 60606. Refer to ad code: SJM-0077-ES.

Minimum Education Required

Bachelor’s or foreign equivalent degree in Computer Science, Mechanical Engineering, Computer Engineering, or in a related field of study.

Minimum Experience Required

Must possess at least 3 years of professional Engineering experience in: (i) executing Holistic and Strategic Design Verification and Validation strategies; (ii) leading, designing, testing, and inspection method development validation activities; (iii) ensuring compliance with FDA, ISO 13485, ISO 14971, and internal Quality Management System (QMS) standards; and (iv) working within a team, and independently, in a geographically diverse business.

Shift

First (Day)

Number of Openings

1

Public Transportation Accessible

Yes

Compensation

$108,451.00 - $156,000.00 / Annually

Postal Code

55442

Job Type

Full Time

Place of Work

On-site

Requisition ID

SJM-0077-ES

Job Benefits

Medical Insurance

Retirement Plan

401(k)

Tuition Reimbursement

Dental

Vision

Holidays, PTO, Sick Days

Life Insurance

Application Instructions

Send resumes to or by mail to Abbott Laboratories, Attn: 26J14A, Willis Tower, 233 S. Wacker Dr., Floor 26, Dept. 32, Chicago, IL 60606. Refer to ad code: SJM-0077-ES.