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.
JOB DESCRIPTION:
Manager, Design Transfer Quality Engineering
Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to:
- Career development with an international company where you can grow the career you dream of.
- Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
- An excellent retirement savings plan with a high employer contribution
- Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
- A company recognized as a great place to work in dozens of countries worldwide 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 the best place to work for diversity, working mothers, female executives, and scientists.
The Opportunity
This position will have responsibility for the design transfer of all Diabetes Care Blood Glucose Monitoring Systems (strips, meters & accessories), FreeStyle Libre portfolio of products, medical device combination products, new medical sensors, Lingo which will deliver products to over 15MM customers globally over the next 5 years with a revenue of over $10Bn. In addition, this position will also be accountable of transfer of all designs (new product introductions, product changes to on market products, test method validations, complaint investigation techniques) into all manufacturing sites, including contract manufacturers.
This position will be based out of our Abbott Diabetes Care in Austin, TX site and the individual will be expected to be onsite Monday-Friday.
What You’ll Work On
- Responsible for implementing and maintaining the effectiveness of the quality system.
- Provides quality support in the transfer of all new products and product changes from R&D into Manufacturing Operations including completion of commercialization activities to launch new products according to division goals.
- Lead project specific deliverables in a specialized area of expertise (e.g. validation, CAPA, Risk Management, etc) within the constraints of limited resources and challenging priorities.
- Assess, implement and improve quality processes and procedures, automated systems and reporting systems for areas of subject matter expertise.
- Supports continuous product and process improvement through mitigations of identified site quality risks and product quality metrics.
- Work effectively with other departments, especially engineering teams, to define requirements and drive quality excellence of products, including design documents review, processes/practices simplification, QMS training, etc.
- May manage Quality Engineers, providing mentoring, technical guidance and career growth planning.
- Utilizes risk management tools and aids for use by the organization in accordance with documented procedures, including but not limited to PFMEA, DFMEA, Fault Tree Analysis, Failure Mode Analysis, etc. Supports design mitigation efforts.
- Decision and recommendations made by this position have a indirect impact on marketed items for domestic and international sales.
- Assure line of communication with Director of Design Transfer on critical quality issues that may result in potential business interruption.
- Approver of change control process to assess and implement changes to DMR documents associated with design transfer activities.
- Facilitates discussions and manages the commercialization of TPM manufactured materials required for the product.
- Recognizes the impact and interconnections in the organization and/or system, develops and recommends alternatives that support project strategies.
- Requires a high level of independence and excellent interpersonal and communication skills.
- Prepare and present written and oral reports and other presentations to internal and external audiences, including senior management.
Required Qualifications
- Bachelors Degree with a minimum 5+ years of progressive work experience in medical device.
- Proven ability to manage and coordinate multiple concurrent projects across diverse international locations, ensuring alignment with regional regulations, cultural nuances, time zones, and stakeholder expectations while maintaining consistent quality, timelines, and budget adherence.
- 25% domestic and (some international) travel will be required for this role.
Preferred Qualifications
Regulatory Knowledge:
- Understanding and complying with regulatory requirements (e.g., FDA, ISO 13485) is critical to ensure that the products meet all necessary standards and can be marketed legally.
Technical Expertise:
- A deep understanding of the technical aspects of medical device design, manufacturing processes, and validation methods is necessary to oversee
the development and transfer processes effectively. - Typically the Subject Matter Expert on one or more Quality System Subsystems.
Quality Control and Risk Management:
- Implementing robust quality control measures and risk management strategies to ensure product safety and efficacy throughout the design transfer and manufacturing processes.
Change Management:
- Managing changes in design, processes, and regulations efficiently to minimize disruptions and ensure continuous improvement.
- Demonstrated experience in working effectively to ensure quality and compliance
requirements are designed/built into the products. - Demonstrated understanding of product development lifecycles, design change and change control, process verification and validation methodologies, manufacturing / production process control methodologies, and servicing.
- Strong leadership skills, including the ability to set goals and provide positive and
constructive feedback respectfully to build positive relationships and improve business results.
Strong Project Management Skills:
- Effective planning, scheduling, and resource allocation are essential to manage the complexities of design transfer & new product introductions.
Cross-Functional Collaboration:
- Working closely with R&D, quality assurance, regulatory affairs, and manufacturing teams ensures that all aspects of the product development lifecycle are aligned and any potential issues are addressed early.
Effective Communication:
- Clear and consistent communication with all stakeholders, including team members, suppliers, and regulatory bodies, is vital to ensure that everyone is on the same page and any issues are promptly addressed.
Apply Now
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.
Divisional Information
Medical Devices
General Medical Devices:
Our medical devices help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks.
Diabetes
We’re focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology.
The base pay for this position is
$97,300.00 – $194,700.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:
Operations Quality
DIVISION:
ADC Diabetes Care
LOCATION:
United States > Texas > Austin : 12501B Research Boulevard
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Yes, 25 % of the Time
MEDICAL SURVEILLANCE:
Not Applicable
SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)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.pdfEEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf