Design Assurance Engineer II

The Opportunity

As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats.

This position works out of our Minnetonka, MN location in the Cardiac Rhythm Management division.

We are seeking a high caliber, motivated, self-driven Design Assurance Quality Engineer II who will assist to assure new or modified products conform to requirements and establish compliance with the quality system. They are 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.

What You’ll Work On

• Execute and support on-time completion of Design Control Deliverables

• Support on-time execution of Quality Plans for internal development, OEM-based, Clinical Product Development (CPDP), and design change projects

• Accountable for Design Verification and Validation planning & execution, statistical analysis, including active cross-functional root-cause analysis investigation & resolution activities

• Lead or support Risk Management activities from product Concept through Commercialization

• Support design test and inspection method development, and lead method validation activities

• Ensure DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps

• Support manufacturing process development & qualification for new product commercialization and product changes

• Support internal & external audit responses

• Support product re-certifications

• Support the establishment of objective, measurable, discrete, and verifiable customer and product requirements

• Support objective component specification definitions, supplied component sampling plan development, and vendor qualifications

• Support execution of biocompatibility and sterilization qualifications

• Complete Document Change Request Reviews in a timely and objective manner

• Additional duties may be identified by functional management based on the current project/business objectives.

• 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.

EDUCATION AND EXPERIENCE YOU’LL BRING

• Bachelors Degree (± 16 years) Engineering or Technical Field OR an equivalent combination of education and work experience

• Masters Degree (± 18 years) Preferred

• 2 years experience

• Previous Quality engineering experience and demonstrated use of Quality tools/methodologies

• Solid verbal, written, and interpersonal skills with ability to effectively communicate at multiple levels in the organization

• 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 in timely manner.

• Strong organizational and follow-up skills, as well as attention to detail.

• Ability to travel approximately 10%, including internationally(if required)

Preferred Qualifications

• Medical device experience preferred, but not required

WHAT WE OFFER

At Abbott, you can have a good job that can grow into a great career. We offer:

• A fast-paced work environment where your safety is our priority (Manufacturing roles only)

• Production areas that are clean, well-lit and temperature-controlled (Manufacturing roles only)

• Training and career development, with onboarding programs for new employees and tuition assistance

• Financial security through competitive compensation, incentives and retirement plans

• Health care and well-being programs including medical, dental, vision, wellness and occupational health programs

• Paid time off

• 401(k) retirement savings with a generous company match

• The stability of a company with a record of strong financial performance and history of being actively involved in local communities

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