Senior Development Quality Engineer

Abbott; Iowa (LA); On-site; USD 78,000 - 156,000; Full time

Benefits offered by this job

Health coverage

Retirement plan

Tuition reimbursement

Education benefits

Job summary

Abbott's Electrophysiology division in Plymouth, MN seeks a Senior Engineer to lead development and sustaining activities for complex medical devices, focusing on disposable catheters. You will guide design verification/validation, run analyses, and mentor junior engineers in a multidisciplinary team.

The role requires a bachelor’s in engineering, 6+ years in new product development, and strong regulatory knowledge. On-site work in Plymouth with ~10% travel; Abbott offers extensive benefits.

Qualifications

• Bachelor's degree in Engineering or technical field.
• Minimum 6 years in new product development.
• Experience with design verification and design validation.
• Knowledge of statistics and DOE; with Minitab.
• Willingness to travel ~10%, including international.
• FDA/IEC 60601, GMP, ISO 13485, ISO 14971 knowledge; medical device experience preferred.

Responsibilities

• Lead complex development projects and quality improvements.
• Drive cross-functional strategies for compliant and efficient solutions.
• Train and develop other engineers.
• Execute design verification/validation strategies.
• Lead root cause investigations and CAPA.
• Ensure DHF content integrity and regulatory compliance.
• Represent the team during FDA/ISO inspections.
• Support establishment of customer and product requirements.
• Support QMS/EMS initiatives and regulatory adherence.
• Perform other related duties as assigned.

Skills

Design verification

Design validation

Applied statistics

Minitab

Regulatory knowledge

Cross-functional

Travel willingness

Medical device experience

Education

Bachelor's degree

Job description

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, nutritionals and branded generic medicines. Our 122,000 colleagues serve people in more than 160 countries.

JOB DESCRIPTION:

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position works out of our Plymouth, MN location in the Electrophysiology division. In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives.

As a Senior Engineer, you will be providing development and sustaining support as a part of a multidisciplinary product development team, overseeing projects throughout concept to launch in all phases of Design Controls with a focus in the disposable catheter. You will be a key contributor to the design, development and testing activities for complex medical devices.

Who we want:

• Critical thinkers: People who challenge status quo and work to find just the right solutions.
• Collaborators: Partners who listen to ideas, share thoughts, and work together to move the business forward.
• Problem Solvers: People who can take on complex problems and apply first principles and sound technical practices.
• Communicators: People who can communicate project progress, data analysis and conclusions effectively across a broad set of stakeholders.
• Responsible: People who own their deliverables and activities and see things through to completion. People who take personal accountability for end results.

What you’ll do:

• 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:
• 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 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.
• Performs other related duties and responsibilities, on occasion, as assigned.

Qualifications:

• Bachelor level 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.

The base pay for this position is

$78,000.00 – $156,000.00

In specific locations, the pay range may vary from the range posted.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf

EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf

JOB FAMILY:

Operations Quality

DIVISION:

EP Electrophysiology

LOCATION:

United States > Minnesota > Plymouth : 5050 Nathan Lane N

WORK SHIFT:

Standard

TRAVEL:

Yes, 5 % of the Time

MEDICAL SURVEILLANCE:

No

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)