Sr. Development Quality Engineer

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 115,000 colleagues serve people in more than 160 countries.

     

JOB DESCRIPTION:

This position is responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within new product development, design verification and validation, manufacturing, or system/services support. ​

• Identify and implement effective process control systems to support the development, verification, validation qualification, and on-going manufacturing of products to meet or exceed internal and external requirements
• Lead, coach, and mentor non-exempt and entry level exempt personnel
• Assist in the development and execution of streamlined business systems which effectively identify and resolve design and quality issues
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving complex design, testing, and quality issues
• Design and conduct experiments for product performance, reliability, safety, and design verification activities
• Appropriately document experiment plans and results, including protocol writing, standards-based test execution, statistical analyses, and reports
• Lead process control and monitoring of CTQ parameters and specifications
• Lead and implement various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing)
• Lead the investigation, resolution and prevention of product, process and design nonconformances, including field performance and complaint investigations as applicable
• Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member)
• ead in the completion and maintenance of risk analysis, ensuring alignment between identified risks, risk controls, and verification evidence.
• Partner with design engineering to plan, review, and approve product verification and validation activities, including electrical, system-level, reliability, and standards-based testing.
• Provide independent quality oversight of testing conducted to applicable international and regulatory standards (e.g., IEC, ISO, ANSI/AAMI, FDA-recognized consensus standards), ensuring test methods, acceptance criteria, and results support product requirements and regulatory compliance.
• Serve as a technical quality subject matter expert for CRM electrical and system-level testing, including implantable pulse generators, leads, programmers, accessories, and supporting systems, as applicable.
• Work with microbiology to ensure appropriate environmental monitoring and that microbiology requirements are considered in product and process development activities
• Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements
• Performs other related duties and responsibilities, on occasion, as assigned.

• Bachelors Degree (± 16 years) in an Engineering or Technical Field (OR)
• An equivalent combination of education and work experience

• Minimum 5 years of Quality, Design Quality, Reliability, Electrical Engineering, or related medical device experience, including support of product development and design control activities.
• Demonstrated supervisory experience preferred. Engineering experience and demonstrated use of Quality tools/methodologies. Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971, design controls, and risk management principles. 
• Solid communication and interpersonal skills.
• Strong project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner 
• Advanced computer skills, including statistical/data analysis and report writing skills.
• Prior medical device experience preferred. 
• Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing).
• Experience supporting design verification and validation activities, including electrical, system-level, reliability, and standards-based testing.
• Working knowledge of applicable consensus standards and regulatory expectations for medical device testing (e.g., IEC, ISO, ANSI/AAMI, FDA-recognized standards), including test method development, protocol review, and technical assessment of results.
• Experience with Cardiac Rhythm Management (CRM) products and technologies preferred, including implantable pulse generators, leads, programmers, or associated systems.
• Experience working in a broader enterprise/cross-division business unit model preferred.
• Ability to work in a highly matrixed and geographically diverse business environment.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment. 
• Ability to leverage and/or engage others to accomplish projects.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Multitasks, prioritizes and meets deadlines in timely manner.
• Strong organizational and follow-up skills, as well as attention to detail. 
• Ability to maintain regular and predictable attendance.

Licenses and Certifications

• ASQ CQE or other certifications preferred

* 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 and @AbbottGlobal.

     

The base pay for this position is

$90,000.00 – $180,000.00

In specific locations, the pay range may vary from the range posted.

     

JOB FAMILY:

Operations Quality

     

DIVISION:

CRM Cardiac Rhythm Management

        

LOCATION:

United States > Sylmar : 15900 Valley View Court

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

Yes, 10 % 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.pdf

     

EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf