Senior Development Quality Engineer
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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 technical analysis, efficient execution, alignment of design outputs, and proper verification techniques.
- 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.
What they're looking for
- 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
Nice to have
- Prior medical device experience preferred.
Summarised by NextRaise from the employer’s description, which follows in full below.
Full description from employer
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:
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 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.
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.
The base pay for this position is
$78,000.00 – $156,000.00In specific locations, the pay range may vary from the range posted.
JOB FAMILY:
Operations Quality
DIVISION:
EP Electrophysiology
LOCATION:
United States > Minnesota > Plymouth : 5050 Nathan Lane N
ADDITIONAL LOCATIONS:
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)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
Company
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