Senior Development Quality Engineer (Product Compliance)
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries.
Our Neuromodulation business is an area of expertise for Abbott. This business includes implantable devices compatible with mobile technology to help people who suffer from chronic pain and movement disorders. Our Solutions include Proclaim (TM) XR SCS System, the #1 Spinal cord stimulator on the market, Proclaim (TM) DRG Neurostimulator, the only FDA approved DRG therapy and a market leader in radiofrequency ablation therapy, Abbott RFA. These non-opioid therapies allow us to provide interventional pain therapy to patients throughout the pain continuum. Our deep brain stimulation technology for progressive diseases help people manage their Parkinson’s disease and essential tremor symptoms, steering away from side effects.
Our location in Plano, TX, currently has an opportunity for a Senior Development Quality Engineer.
We are seeking an experienced, high caliber Development Quality Engineer to assure new or modified products conform to product / quality standards and establish compliance with the quality system. 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. We are team-oriented, fast-paced, and progressive. We value people with great ideas who partner with others both internally and externally to take action and accomplish goals.
Participate in or lead teams in supporting quality disciplines, decisions, and practices for programs to develop the next generation of devices (e.g., represent the Quality function as a Project Team Member on development programs).
• Support on-time execution of Design Development Plans and Design Change Plans for internal product development process (PDP)
• Work with design engineering to execute and/or support various areas of Design Control QS processes, such as Design Input requirements, Design outputs, Design verification and Design validation
• Ensure compliance to product standards (60601-x; 14708-x)
• Generate protocols and execute safety testing at external test labs
• Generate essential requirements checklists & reports
• Lead identification of essential outputs and generate Essential Output reports
• Complete Document Change Order Reviews in a timely and objective manner
• Lead Risk Management activities from product Concept through Commercialization.
• Ensure DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps (e.g. Design review robustness)
• 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.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
• Exercise judgment in planning and organizing work; monitor performance and report status
• Bring additional development expertise to the product development process
• Build strong collaborative partnerships with Program Management and Research & Development to ensure cross functional needs are met without creating barriers to development cost, time, and scope.
Your experience(s), education and knowledge will further expand Abbott’s marketplace success:
• Bachelor level degree in Electrical Engineering or Technical Field
• 5-8 years’ experience
• Previous Medical Device safety testing experience
• Prior design and development experience in a related field
• Working knowledge of FDA 21 CFR Part 820, GMP, ISO13485, ISO 14971, EN 45502-1, ISO14708, AIMDD, EU MDR, etc.
• Excellent verbal, written, and interpersonal skills with ability to effectively communicate at multiple levels in the organization
• Strong analytical/problem solving, negotiation, and presentation skills.
• Project management and leadership skills, including the demonstrated ability resolve quality-related issues with cross-functional teams in a timely and effective manner
• Advanced computer skills, including statistical/data analysis and report writing skills
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• Multitasks, prioritizes and meets deadlines in timely manner.
• Strong organizational and follow-up skills, as well as attention to detail.
WHAT WE OFFER
At Abbott, you can have a good job that can grow into a great career. We offer:
• 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
Learn more about our benefits that add real value to your life to help you live fully: www.abbottbenefits.com
Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at [Register to View] on Facebook at [Register to View] and on Twitter @AbbottNews and [Register to View]