Design Assurance Engineer II
About The Position
Design Assurance Engineer II 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 Design Assurance Engineer II, 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.
Requirements
- Bachelor level degree in Engineering or Technical Field
- Minimum of 3 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.
Nice To Haves
- Demonstrated supervisory experience preferred.
- ASQ CQE or other certifications preferred.
- Experience working in a broader enterprise/cross-division business unit model preferred.
- Prior medical device experience preferred.
Responsibilities
- Be a core team member to implement complex development projects including quality improvement initiatives.
- Cross-functional team member and driving 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.
- Support design characterization activities for development projects
- Apply statistics to design and verification decisions.
- 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.
- Participate in 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
Benefits
- 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.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
