Abbott

Sr. Development Quality Engineer

Abbott • $90K — $180K *
Sylmar, CA 91342In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
Today
Be an Early Applicant
Job Overview by Ladders

Qualifications

  • Bachelor's degree in Engineering or Technical Field or equivalent education and work experience
  • Minimum 5 years of experience in Quality, Design Quality, Reliability, or Electrical Engineering in the medical device field
  • Supervisory experience preferred with expertise in Quality tools and methodologies
  • Strong project management and leadership skills with the ability to lead multi-departmental teams
  • Advanced computer skills for statistical analysis and report writing
  • Experience with product and process improvement methodologies, preferably Six Sigma and Lean Manufacturing
  • Knowledge of FDA guidelines and ISO standards specific to medical device testing.

Responsibilities

  • Identify and implement effective process control systems for product development
  • Lead, coach, and mentor junior personnel in quality engineering practices
  • Develop and streamline systems to resolve design and quality issues
  • Apply systematic problem-solving methodologies to address complex issues
  • Design and conduct experiments on product performance and reliability
  • Document experiment plans and results, incorporating statistical analyses
  • Lead the monitoring of critical parameters and specifications for quality assurance.
  • Oversee compliance with relevant international and regulatory standards during testing.

Benefits

  • Free coverage in HIP PPO medical plan after completing a wellness assessment
  • Comprehensive health and wellness benefits to support work-life balance
  • Diverse opportunities within Abbott for career advancement
  • Support for quality management systems and regulatory requirements
  • Collaboration with cross-division teams in a geographically diverse environment.
Full Job Description
JOB DESCRIPTION:

MAIN PURPOSE OF ROLE

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.

MAIN RESPONSIBILITIES

  • 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.


QUALIFICATIONS

Education

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


Experience/Background

  • 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


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.

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)

About Abbott

Abbott Careers

Joining Abbott means becoming part of a globally diverse team dedicated to making a lasting impact on human health. As a leader in healthcare innovation, Abbott provides a dynamic workplace where careers flourish through growth, leadership, and diversity training.

Opportunities at Abbott

Explore a world of opportunities with our team. Whether you're seeking job opportunities in engineering, marketing, research, or healthcare, Abbott offers a variety of positions that allow professionals to grow their careers. Our commitment to diversity and innovation is evident in every aspect of our work, fostering an inclusive culture that values each team member's contribution.

Work You'll Do

At Abbott, every role contributes to our mission of helping people live fuller lives through better health. From groundbreaking research in medical devices to advancements in pharmaceuticals, our team is at the forefront of healthcare innovation. By joining Abbott, you are not just accepting a job; you are embarking on a path of professional and personal growth.

Internship Programs

Kickstart your career with an Abbott internship. Our programs provide invaluable industry experience and a chance to develop essential skills in a real-world setting. Interns at Abbott work on projects that matter, gaining the experience and knowledge necessary to succeed in their future careers.

Professional Development

Abbott is dedicated to the continuous professional development of its employees. With access to cutting-edge technology, leadership programs, and diversity training, our team members are equipped to lead and innovate within the healthcare industry. We support your career journey with robust training programs, mentorship, and opportunities for networking and professional growth.

Benefits and Culture

Our employees enjoy comprehensive benefits designed to support their life and well-being. From health insurance to retirement plans, we ensure our team has everything they need to thrive. Abbott's culture is built on a foundation of respect and integrity, united by a shared commitment to improving health outcomes.

Join Our Team

Discover the impact you can make with a career at Abbott. We are hiring individuals who are passionate, curious, and driven to lead. Search open positions that match your skills and interests on our Jobs page. Prepare your resume, sharpen your interview skills, and get ready to join a team that's at the cutting edge of healthcare solutions.

Stay Connected

Keep up to date with career tips, industry insights, and company news—all from the people who work here. Subscribe to our Careers Blog and personalize your subscription to receive job alerts and insider tips tailored to your preferences.

Explore Abbott

With a commitment to improving life through innovation, leadership, and diversity, Abbott is a place where you can fulfill your potential. See what exciting and rewarding opportunities await at Abbott by exploring our career opportunities today.

SEARCH ABBOTT JOBS

Join us in our mission to make the world a healthier place through innovation, leadership, and diversity. Your journey to a fulfilling career at Abbott starts here.
Learn more about Abbott
Size
113,000 employees
Market Cap
$189 billion
Industry
Healthcare
Net Income
$4.4 billion
Founded
1944
5 Year Trend
+15.6%
Revenue
$34.6 billion
NASDAQ
ABT
* Ladders Estimates

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