Senior Development Quality Engineer

Job Duties

SR DEVELOPMENT QUALITY ENGINEER – St. Jude Medical, an Abbott Labs Co. / Plymouth, MN

Responsible for leading teams in supporting quality disciplines, decisions, and practices, serving as a Core Team Member representing the Quality function. Lead on-time completion of projects for new product development or projects for on-market products such as indications for use expansions, market expansions, design changes, material qualifications, supplier changes, supplier facility moves and regulatory submissions for United States, Europe and other geographies. Maintain strong collaborative relationships with cross-functional teams, including Program Management, Research & Development, Regulatory Affairs, Process Development and Manufacturing Engineering. Work effectively in a matrixed and geographically diverse environment. Ensure customer, external, and product requirements are objective, measurable, discrete, and verifiable. Support test and inspection method development, including validation activities. Support design verification and design validation activities, including effective root-cause investigation and resolution. Use statistical tools such as Minitab to conduct normality assessments and tolerance analyses. Maintain Design History Files for assigned products and projects, such as, update traceability matrices, requirement documents such as customer requirements, product requirements. Lead Risk Management activities, including analyzing field data and updating Risk Management File documents such as Failure Modes and Effects Analysis, Hazard Analysis, Risk Management Plan and Risk Management/Report. Lead and support Corrective Action Preventative Actions (CAPAs) in a timely manner. Ensure compliance of medical device design and manufacturing processes with federal and international regulations and industry standards, including 21 CFR Part 820, ISO 13485, ISO 14971, EUMDR, and MDSAP. Support internal and external audits as a Subject Matter Expert for Design Controls. Assist in the preparation of regulatory submission documentation and respond to inquiries from regulatory agencies. Develop and revise standard operating procedures, detailed work instructions (DWIs) and templates to ensure best practices and compliance. Support divisional initiatives in alignment with Quality Management Systems.

Bachelor’s or foreign equivalent degree in Industrial Engineering, Mechanical Engineering, Biomedical Engineering or in a related engineering or scientific field of study with at least 5 years of professional medical device design or manufacturing experience. In the alternative, will accept a Master’s degree with at least 3 years of professional medical device design or manufacturing experience. Each alternative requirement must possess at least 3 years of professional experience in the following: (i) ensuring customer, external, and product requirements are objective, measurable, discrete, and verifiable; (ii) supporting test and inspection method development, including validation activities; (iii) supporting design verification and design validation activities, including effective root-cause investigation and resolution; (iv) using statistical tools such as Minitab, to conduct normality assessments and tolerance analyses; (v) maintaining Design History Files for assigned products and projects such as update traceability matrices, requirement documents such as customer requirements, product requirements; (vi) leading Risk Management activities, including analyzing field data and updating Risk Management File documents such as Failure Modes and Effects Analysis, Hazard Analysis, Risk Management Plan and Risk Management Report; (vii) leading and supporting Corrective Action Preventative Actions (CAPAs); (viii) ensuring compliance of medical device design and manufacturing processes with federal and international regulations and industry standards, including 21 CFR Part 820, ISO 13485, ISO 14971, EUMDR, and MDSAP; (ix) supporting internal and external audits as a Subject Matter Expert for Design Controls; (x) preparation of regulatory submission documentation and respond to inquiries from regulatory agencies; and (xi) developing and revising standard operating procedures, detailed work instructions (DWIs) and templates to ensure best practices and compliance. Employer will accept any suitable combination of education, training, or experience.

An EOE. 40 hrs/wk. $128,232 - $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-0085-ES

Minimum Education Required

Bachelor’s or foreign equivalent degree in Industrial Engineering, Mechanical Engineering, Biomedical Engineering or in a related engineering or scientific field of study with at least 5 years of professional medical device design or manufacturing experience. In the alternative, will accept a Master’s degree with at least 3 years of professional medical device design or manufacturing experience. Employer will accept any suitable combination of education, training, or experience.

Minimum Experience Required

Each alternative requirement must possess at least 3 years of professional experience in the following: (i) ensuring customer, external, and product requirements are objective, measurable, discrete, and verifiable; (ii) supporting test and inspection method development, including validation activities; (iii) supporting design verification and design validation activities, including effective root-cause investigation and resolution; (iv) using statistical tools such as Minitab, to conduct normality assessments and tolerance analyses; (v) maintaining Design History Files for assigned products and projects such as update traceability matrices, requirement documents such as customer requirements, product requirements; (vi) leading Risk Management activities, including analyzing field data and updating Risk Management File documents such as Failure Modes and Effects Analysis, Hazard Analysis, Risk Management Plan and Risk Management Report; (vii) leading and supporting Corrective Action Preventative Actions (CAPAs); (viii) ensuring compliance of medical device design and manufacturing processes with federal and international regulations and industry standards, including 21 CFR Part 820, ISO 13485, ISO 14971, EUMDR, and MDSAP; (ix) supporting internal and external audits as a Subject Matter Expert for Design Controls; (x) preparation of regulatory submission documentation and respond to inquiries from regulatory agencies; and (xi) developing and revising standard operating procedures, detailed work instructions (DWIs) and templates to ensure best practices and compliance. Employer will accept any suitable combination of education, training, or experience.

Shift

First (Day)

Number of Openings

1

Public Transportation Accessible

Yes

Compensation

$128,232.00 - $156,000.00 / Annually

Postal Code

55442

Job Type

Full Time

Place of Work

On-site

Requisition ID

SJM-0085-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-0085-ES