Design Assurance Engineer II

• 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 a high employer contribution
• Tuition reimbursement, the

• 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.

• 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

• 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.

• Bachelor level degree in Engineering or Technical Field; advanced degree / Biomedical Engineering / Electrical Engineering / Computer Science preferred.
• 3-5+ 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.

Abbott