Abbott · 16 hours ago
Design Controls Manager
Illinois, United States
Full-time
Onsite
Mid, Senior Level
$99K/yr - $199K/yr
5+ years expAbbott is a global healthcare leader that helps people live more fully at all stages of life. They are seeking a Design Controls Manager to manage process and compliance for the Abbott Diabetes Care R&D team, ensuring that design controls meet global regulatory standards while promoting efficiency. The role involves optimizing design control requirements, conducting training, and participating in audits as a design controls expert.
BiotechnologyEmergency MedicineGeneticsHealth CareHealth DiagnosticsManufacturingMedicalMedical DeviceNutritionPharmaceutical
Responsibilities
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
Qualification
Required
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 will be 25% including periodic international travel
Company
Abbott
Abbott is a healthcare company that produces diagnostic kits, medical devices, nutritional products, and branded generic medicines.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$6.79M2011-03-15Post Ipo Debt· $0.1M
2009-03-16Post Ipo Debt· $6.69M
1980-12-12IPO
Leadership Team
Robert Ford
President & Chief Executive Officer
Mike Peterson
Senior Vice President
Recent News
2026-01-07
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