Design Controls Manager

Abbott

19d•Remote

About The Position

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. 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.

Requirements

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.

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.