Quality Development Engineering Manager

Abbott   •  

Sylmar, CA

Industry: Biotech/Pharma

  •  

11 - 15 years

Posted 395 days ago

30053497

At Abbott, we're committed to helping you live your best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 94,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve. Please note that candidates need to be eligible to workin the U.S. without Abbott sponsorship.

     

JOB DESCRIPTION:

We are seeking an experienced, high caliber Manager, Development Quality Engineering (Software). Working within broad objectives, the Manager is responsible for Development Quality Engineering (DQE) personnel and functional support of Product Development Programs (PDP), PDP Extension Projects, and Continuous Improvement/Continuation Engineering (CI/CE) activities. Specifically, the Manager is responsible for providing oversight, coaching and guidance for DQE teams with regard to PDP planning and execution of assigned deliverables, and cross-functional support of other tasks, for the program(s).  These may include, but are not limited to

Requirements Definition; Design input and output requirements/matrix; Standards Compliance Identification/Assessment; Product Life-Cycle Risk Management Activities; Software Design Verification and Validation activities; Software Test Method/Inspection Method Development and Validation; Design Review, Change & Transfer for Manufacturability.

Impact this role will have on Abbott:

  • Develop, maintain and oversee the Software Quality Development and software validation activities .
  • Develop and conduct training of company personnel for the Software Quality Development.
  • Support software-related CAPA and Health Hazard Evaluations activities.
  • Provides support for Audits as needed.
  • Work with Research and Development in the completion of system/software requirements and other verification and validation processes.
  • Create and execute or direct development software validation protocols traceable to system/software requirements.
  • Develop and implement solutions for controlling code and administer Code Control and Software Event/Defect Tracking software systems.
  • Assist in the completion and maintenance of risk analysis, focused on software and cybersecurity related risks.
  • Design and implement various product and process software improvement methodologies (i.e. Six Sigma and Lean Manufacturing).
  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving issues.
  • Supervises Development Software Quality engineers and technicians
  • Develops and manages department operating budget.
  • Hires and retains a diverse, highly qualified staff and provides ongoing performance feedback. Sets goals which align to department plans and manages the execution of goals through coaching and mentoring. Maintains a safe and professional work environment.
  • Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
  • Complies with U.S. Food and Drug Administration (FDA) regulations, IEC 62304, IEC 82304 and other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
  • Ensures awareness and compliance is maintained as applicable software standards change.
  • Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Your experience(s), education and knowledge will further expand Abbott’s marketplace success:

  • A Bachelor's degree (preferably in an applicable Software discipline) with ten (10) or more years of progressively increasing responsibility and work experience in Quality Design, Engineering, and/or Research & Development in the medical device manufacturing industry
  • Five or more years of service with increasing responsibility within a management/Leadership role (preferably in Quality Design and/or Engineering)
  • Broad cross-disciplinary and in-depth knowledge and experience with industry accepted quality assurance design methodologies, project management, and product life-cycle risk management theory and practical application
  • Direct ‘hand’s-on’ medical device software  development experience
  • Experience working in a broader enterprise/cross-divisional/matrixed business unit model preferred
  • Ability to work collaboratively within a geographically diverse business environment and personnel base
  • Strong leadership skills, including the ability to set and administer goals, provide positive, constructive, and consistent feedback respectfully, the capability to build positive relationships to improve business results, as well as coach, mentor and develop junior-level engineering staff
  • Ability to work effectively within a team in a fast-paced, ever-changing environment
  • Strong verbal and written English communication skills with an ability to effectively communicate at multiple hierarchal levels in the organization
  • Ability to multi-tasks, prioritize, meets/exceed deadlines and hold themselves, staff, and others accountable
  • Strong organizational, strategic planning, and tactical execution/follow-up skills
  • Ability to maintain regular and predictable attendance

Your preferred qualifications and education:

  • Advanced degree in Software development/Testing/cybersecurity.
  • Advanced credential(s) in a relevant Quality/Engineering discipline/concentration. Ex:  Professional certification or designation, such as CQE, CSQE, CRE and/or CMQ/OE