Development Quality Engineer I

Abbott•Los Angeles, CA
•$73,900 - $116,000•Onsite

About The Position

The Development Quality Engineer I is responsible for ensuring requirements for device and combination products are met through execution of Abbott standard operating procedures and Product Lifecycle Management. The role focuses on quantitative analysis and data management, using technology to collect, clean, analyze, predict, and communicate information. It involves examining and interpreting data, developing analysis plans to address business questions, and presenting insights to site and executive management. The position works with cross-functional teams and business partners to develop and validate test methodologies, refine analyses, improve processes, and implement continuous improvements throughout the data lifecycle. The engineer serves as a subject matter expert in cross-functional meetings and audits, ensures compliance with relevant regulations, standards, and site procedures, and may lead small, well-defined projects. The role is based at Abbott's Sylmar, California location and includes approximately 5% travel.

Requirements

  • Bachelor's degree in Engineering, Life Sciences, or Physical Sciences, or an equivalent combination of education and work experience.
  • Minimum 1 year of experience.
  • 0–2 years of experience in Quality Assurance, Technical Quality, or equivalent.
  • 1–2 years of experience in the pacing industry; quality experience is desired.
  • Knowledge of Design Controls, verification and validation activities, manufacturing practices or processes, and statistical techniques.
  • Ability and willingness to learn applicable regulations and standards, including FDA, QSR, and ISO regulations.
  • Demonstrated written and verbal communication, interpersonal, presentation, analytical, and organizational skills, and ability to meet deadlines.
  • Ability to work effectively with engineers, technical specialists, vendors, and customers and coordinate multiple assignments simultaneously.
  • Personal computer skills, including Microsoft Office or equivalent, for graphics, word processing, databases, authoring programs, and presentation materials.
  • Ability to work in a highly matrixed, geographically diverse business environment, both as part of a team and as an individual contributor.
  • Ability to leverage or engage others to accomplish projects and communicate effectively at multiple organizational levels.
  • Ability to multitask, prioritize, meet deadlines, and demonstrate strong follow-up and attention to detail.
  • Ability to travel.
  • Strong problem-solving and analytical skills, including statistical application experience.

Nice To Haves

  • Bachelor's degree focused in Data Analytics, Data Science, or a similar discipline, including Engineering, Mathematics, Computer Science, Statistics, or Physics.
  • 1–2 years of related work experience and a good understanding of the specified functional area.
  • Experience in the life sciences or healthcare industry.
  • Experience with database applications and programming, such as SQL, Python, R, Java, Scala, or C++ in Linux/Unix or equivalent.
  • Experience implementing process improvements and efficiencies.
  • Strong Excel skills.
  • Experience working in a broader enterprise or cross-division business unit model.
  • Self-starter able to plan work to meet deadlines; adaptable, self-motivated, eager to learn, and possessing strong interpersonal skills.

Responsibilities

  • Ensure requirements for device and combination products through Abbott standard operating procedures and Product Lifecycle Management.
  • Collect, clean, analyze, predict, and communicate information using relevant technologies.
  • Examine and interpret data and develop analysis plans to answer business questions.
  • Analyze data, derive insights, and present results clearly to site and executive management.
  • Work with cross-functional teams to devise test methodologies that validate data models.
  • Work closely with business partners to understand the domain and refine analyses.
  • Identify opportunities to improve the efficiency and effectiveness of systems and processes.
  • Implement continuous improvement opportunities throughout the data lifecycle.
  • Act as a subject matter expert in cross-functional team meetings and internal and external audits.
  • Ensure compliance with associated regulations, standards, and site procedures.
  • May act as project lead for small, well-defined projects.

Benefits

  • Training and career development, including onboarding programs for new employees and tuition assistance.
  • Competitive compensation, incentives, and retirement plans.
  • Medical, dental, and vision care, wellness programs, and occupational health programs.
  • Paid time off.
  • 401(k) retirement savings plan with a generous company match.
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