Design Controls Subject Matter Expert

About the Opportunity

Design Controls subject matter expert managing process and compliance to process supporting Abbott Diabetes Care R&D team. Interfaces directly with Regulatory, Quality, Operations, and R&D directors, managers and SMEs to ensure that the design controls and related processes meet global regulatory standards and guidance while promoting efficiency and maintaining the ability to process releases of both hardware and software, product and non-product, medical device and non-medical device, in a timely manner.

What You'll Work On

• Partner in optimizing, streamlining, and increasing compliance with design control requirements for Abbott Diabetes Care products: hardware, embedded software, and SaMD
• Lead process development and process improvement projects with world-wide cross-functional teams
• Conduct training on general design controls
• Develop and deliver training specific to process changes
• Demonstrate leadership in change management practices
• Ensure conformity of processes and records to global regulatory standards and internal policies and procedures
• Audit design records as required to ensure conformance; work with R&D and QA teams to evaluate and remediate non-conformances
• Perform gap analyses to international regulatory standards and guidance and propose policy and procedure updates to conform
• Maintain expertise in global design controls and design and development standards and guidance including ISO13485, ISO14971, 21CFRPart820, MDSAP, IEC60601, IEC62304, IEC62366, Agile software development, etc.
• Train and mentor R&D and QA resources in subject matter expertise to ensure alignment and acceptance of organization with policies and procedures
• Participate in audits (FDA, ISO, Partner, internal) as a R&D representative and design controls expert
• Build technical knowledge of the business product portfolio and maintain awareness of program initiatives and product ecosystem developments
• Partner with R&D resources to ensure alignment and compliance when choosing and implementing software tools for design and development activities

Required Qualifications

• BS in Management, Engineering or Science preferred, or equivalent combination of work experience and education
• 5+ years Quality or R&D experience at a medical device company
• In-depth knowledge of the Quality System Regulation (QSR), ISO 13485, MDSAP, and EU Medical Device Regulation
• High level of knowledge of all QMS sub systems including: CAPA, internal audits, risk management, design control, verification and validation, internal and external audits, management responsibility, training
• Experience leading a design and/or design processes in a medical device company which includes software as a medical device product
• Demonstrated leadership through influence
• Must be able to communicate globally and create followership
• Must possess strong written, verbal and interpersonal communication skills and work independently as well as in close collaboration with others

Travel Requirements

• 25% travel including periodic international travel

Work Details

Job Family: Product Development

Division: ADC Diabetes Care

Location: United States of America

• Remote

Additional Locations: United States > California

• Remote

Work Shift: Standard

Medical Surveillance: Not Applicable

Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Compensation

The base pay for this position is $99,300.00 – $198,700.00. In specific locations, the pay range may vary from the range posted.

Equal Opportunity

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

• EEO is the Law link
• English: http://webstorage.abbott.com/common/External/EEO_English.pdf
• EEO is the Law link
• Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf

About Abbott

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 114,000 colleagues serve people in more than 160 countries.

For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it's next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.

The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life's greatest health challenges.

We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.