Manager, Software Design Controls

2 months ago

Plano, United States Abbott Laboratories Full time

Job Title

Manager, Software Design Controls

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. Youâll also have access to:

  • Career development with an international company where you can grow the career you dream of.
  • Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
  • An excellent retirement savings plan with high employer contribution
  • Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelorâs degree.
  • A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
  • A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position works out of our Plano, TX location in the Neuromodulation Division. Our Neuromodulation business includes implantable devices compatible with mobile technology to help people who suffer from chronic pain and movement disorders. These non-opioid therapies allow us to provide interventional pain therapy to patients throughout the pain continuum.

It sounds like science fiction: sending small electrical pulses to the spine to block pain signals or to the brain to suppress tremor.  As a Software Quality Manager at Abbott Neuromodulation, you will have the opportunity to develop technology platforms that improve the lives of those suffering from chronic pain and movement disorders.

Each employee can make a difference at Abbott and has the power, either individually or as a team, to influence the success of the company. We are team-oriented, fast-paced and progressive. We value people with great ideas who partner with others both internally and externally to take action and accomplish goals.

The Opportunity

This position works out of our Plano, Texas location in the Neuromodulation Division.  Our Neuromodulation business includes implantable devices compatible with mobile technology to help people who suffer from chronic pain and movement disorders.

The Manager, Software Design Controls is responsible for leading a team of quality and development engineers to solve problems and make sound design recommendations, in accordance with corporate, divisional and applicable regulatory requirements.  Provides leadership and mentoring to engineers with the capability to perform hands-on participant as necessary.

What Youâll Work On

  • Provide guidance and strategic input to product development teams for product software (embedded and mobile, medical and non-medical) and non-product software.
  • Contributes to the development of internal Design Controls processes to meet the needs of an evolving technology and regulatory landscape around embedded and mobile software platforms.
  • 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.
  • Assess resource needs to assure that the accurate level of quality support is provided when needed with the competencies needed.
  • Develops direct reports by securing appropriate training, assigning progressively challenging tasks, applying progressive disciplinary action as appropriate and conducting formal written and verbal performance reviews.
  • Monitors work operations and provides direction and guidance to experienced exempt employees or skilled nonexempt staff to achieve unit or project goals.
  • Ensure that appropriate risk management processes are in place, focused on software related risks including design, cybersecurity, and data integrity risks.
  • Lead, oversee or participate in multiple portions of the Quality System, including but not limited to Management Review, Internal Audit, Audit Readiness, NC/CAPA, Document Control, Training, Product Release, and others as needed.
  • Be an effective member of the cross-departmental Functional Management Team to foster continuous quality compliance, cost, and proactive improvements.
  • Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.  Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
  • Ensures sustaining support of Quality System and regulatory compliance by individually working quality system issues and by delegating project work for maintaining quality system capability.

Required Qualifications

  • Bachelorâs degree, preferably in Engineering, Technical Field, Life Science, or closely related discipline.
  • 8+ yearsâ experience in a Quality, Regulatory, or product development role in a regulated industry.
  • 3+ yearsâ experience leading a team of technical/quality professionals.

Preferred Qualifications

  • Prior experience in a software-focused company or company with software as a medical device (SAMD).

Apply Now

* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:  www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews.



The base pay for this position is $95,000.00 â $190,000.00. In specific locations, the pay range may vary from the range posted.

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