Sr. Hardware Design Quality Engineer

About Abbott

Abbott Rapid Diagnostics is part of Abbott’s Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies to support diagnostic testing which provides important information for treatment and management of diseases and other conditions.

The position of Senior Design Quality Engineer is within our Infectious Disease Developed Markets business unit located at Scarborough, Maine. In this role you will actively participate in product development and transfer activities, ensuring product and process conformance to FDA and ISO 13485 standards. This position will review validation methods and protocols, test methods, statistical analysis methods and specification derivation and assignment.

Review new and modified product designs for quality characteristics; including manufacturability, serviceability, and conformance to product requirements. The position is responsible for training other Design Quality Engineers and Quality Assurance personnel in Design Controls and Risk Management. This role requires strong communication, interpersonal and organizational skills, and a solid understanding of the application of FDA, ISO 13485, and ISO 14971 standards.

If you seek a dynamic role where your contributions will pave the way in developing new products, systems, and processes, come work with us!

This job description will be reviewed periodically and is subject to change by management.

• Represent the Quality function to provide design assurance support in the design and development of medical device products and facilitate the application of design controls and risk management.
• Providing training and guidance to other Design Quality Engineers and Quality Assurance professionals on new product development and change processes.
• Act as a reviewer and approver of validation methods and protocols, test methods, statistical analysis methods and specification development.
• Review new modified product designs for quality. Ensure that product development projects and changes to existing products are conducted in compliance with the FDA Quality System Regulation and other global regulations.
• Act as a key contributor to development and validation plans and processes.
• Act as a key team member in establishing, communicating and mitigating risks.
• Ensure successful transfer of new products to manufacturing.
• Review design history files and technical files for conformance to applicable requirements.
• Support the continuous improvement to the Quality Management System, with a specialty focus on design controls and associated processes.
• Identify and propose remediation for existing and potential quality issues; act as project team quality solution provider to maintain compliance.
• Provides leadership in all areas of the Quality System, including but not limited to design controls, risk management, etc.
• Provides leadership in the understanding of FDA and applicable non‑US regulations pertaining to medical or pharmaceutical manufacturing, including hardware, software, and bioassay systems.

Required

• Bachelors’ degree (B.S.) in a Science related field, or equivalent combination of education and experience
• 5+ years related experience and/or training in a Quality and/or Development Position.
• Significant experience in risk management throughout the product lifecycle, including a strong working knowledge of ISO 14971

Preferred

• Experience supporting ISO 13485 inspections and FDA inspections.
• Working knowledge of quality techniques such as root cause analysis, 5 why’s, and Ishikawa diagrams.
• Experience in a multi‑site development environment.
• Experience in compliance management within a rapid‑growth, dynamic organization.

• Communicates effectively at all levels within Quality as well as cross‑functionally with departments such as R&D, Regulatory, Manufacturing, and Marketing
• Excellent problem solving and decision‑making skills.
• Initiative to work towards goals with minimal supervision

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

The base pay for this position is $90,000.00 – $. In specific locations, the pay range may vary from the range posted.