Engineer I

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. Youll also have access to:

• Career development with an international company where you can grow the career you dream of.

• Employees can qualify forfree medical coverage in ourHealth Investment Plan (HIP) PPOmedical plan in the next calendar year.

• 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 bachelors degree.

• A company recognized as a great place to work in dozens of countries worldwide 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

This position works out of our St. Paul MN location in the Electrophysiology Abbotts Electrophysiology (EP) business were 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 an Engineer I you will be providing development support as a part of a multidisciplinary product development team overseeing projects throughout concept to launch in all phases of Design Controls with focus on medical electrical systems. 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 Youll Work On

• Lead and implement complex development projects including quality improvement initiatives.

• Sets strategies for cross-functional teams and drives towards compliant and efficient solutions to complex problems.

• 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.

• Ensure DHF content integrity completeness and regulatory / standards compliance; collaboratively communicating & resolving gaps.

• Support and ensure internal & external audit responses and on-time product re-certifications.

• 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.

Required Qualifications

• Bachelor level degree in Engineering or Technical Field; advanced degree / Biomedical Engineering / Electrical Engineering / Computer Science preferred.

• 0-2 years Engineering experience with new product development

• Understanding of design verification and design validation techniques.

• understanding 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:

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.

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