Lead Development Quality Engineer

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locations

United States - Minnesota - St. Paul

time type

Full time

posted on

Posted Yesterday

job requisition id

31085103

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 114,000 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 your 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

.
Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
An excellent retirement savings plan with a 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

the best place to work for diversity, working mothers, female executives, and scientists.
The Opportunity
The

position of

Lead Development Quality Engineer is within our Structural Heart team at our St. Paul, MN location.
With our Structural Heart division, the business purpose is to restore health and improve quality of life

through the design and provision of

device and management solutions for

the treatment of

structural heart disease.
The individual in this position will ensure that new or modified products conform to requirements and establish compliance with the quality system. This position is responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs. This position will support new product development projects

as well as support

the sustainability of commercially released products. This position may also support manufacturing processes to meet daily production schedules while enhancing productivity and product quality.
What You’ll Work On
Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member).
Lead on-time completion of project supported Quality deliverables and business initiatives.
Support the definition of objective, measurable, discrete, and verifiable customer

requirements, external requirements

, and product requirements.
Lead Risk Management activities from product Concept through Commercialization, including analyzing field data to support new product development and

support Failure Mode Effects Analysis

.
Support Test and Inspection Method development

including

Method Validation activities.
Support Design Verification and Design Validation planning and execution, including cross-functional root-cause analysis investigation and resolution activities.
Support manufacturing process development and qualification for new product commercialization and product changes.
Accountable for Process Validation planning and execution, including active cross-functional root-cause analysis investigation and resolution activities.
Identify and implement effective Process Control and monitoring of CTQ parameters and specifications.
Maintain high standards for Device History File (DHF) content completion, integrity, and regulatory / standards compliance; collaboratively identify, communicate, and resolve gaps.
Support, review, and approve Document Change Order and CAPA records

in a timely and objective manner

.
Support product builds in the cleanroom for development and commercial activities.
Lead and implement technical team strategy and roadmap.
Assist in

the development of

direct reports by securing appropriate training, assigning progressively challenging tasks, applying progressive disciplinary action as

appropriate

, and conducting formal written and verbal performance reviews.
Be innovative, resourceful, and work with minimal direction.

Have excellent

prioritization,

organization, problem-solving, communication, and team leadership skills. Work effectively with cross-functional teams.
Build strong collaborative partnerships with cross-functional teams

including

Program Management, Research & Development, and Process Development

to

ensure cross-functional customer needs

are met

without creating barriers to development cost, time, and scope.
Other

Responsibilities:
Support regulatory audits as a Subject Matter Expert for Design Controls and other

aspects of the quality system

.
Support and ensure internal & external audit responses and on-time product re-certifications.
Writes and revises SOPs, controlled forms, and related documents to ensure best practices and

maintain

compliance.
Participate in Corrective Action/Preventive Action (CAPA) process

including

the investigation of

failures or deviations, as required.
Additional duties may

be identified

by functional management

based on current project/business objectives.
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.
Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
Required Qualifications
Bachelor’s degree within an Engineering field or a closely related discipline.
6-7+ years of medical device engineering experience and demonstrated use of Quality tools/methodologies.
Familiar with 21 CFR Part 820, ISO 13485, ISO 14971, EUMDR, and MDSAP.
Solid verbal, written, and interpersonal skills with the ability to effectively communicate at multiple

levels in the organizations

.
Demonstrated

ability to guide junior team members.
Ability to work in a highly matrixed and geographically diverse business environment.
Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
Ability to leverage

and/or

engage others to accomplish projects.
Multitasks prioritizes

and

meets deadlines promptly.
Ability to travel occasionally (

Preferred

Qualifications:
Medical device experience with bioprosthetic heart valve development or manufacturing or

other

implantable device development is strongly preferred.
Previous Development Quality Engineering experience.
ASQ CQE or other certifications.
* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.
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 Twitter @AbbottNews.
The base pay for this position is
$83,000.00 – $166,000.00

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

Operations Quality

DIVISION:

SH Structural Heart

LOCATION:

United States > Minnesota> St. Paul > Woodridge : 177 East County Rd B

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

Yes, 5 % of the Time

MEDICAL SURVEILLANCE:

No

SIGNIFICANT WORK ACTIVITIES:

Keyboard use (greater or equal to 50% of the workday)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

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Abbott

is about the power of health. For more than 135 years,

Abbott

has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.
The people of

Abbott

come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges.
We invite you to explore opportunities at

Abbott

, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer,

Abbott

welcomes and encourages diversity in our workforce.

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