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UO
Mechanical Engineer II
University of Colorado Denver
Boulder, CO
- $34,986 USD / year
A Mechanical Engineer II is a mechanical engineer that has shown capability to perform designs, analyses, and / or perform tests with support from peers, the lead ME, and / or other…
Added 22 mins ago
Lead HRSG Application Engineer
GE Vernova
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The Heat Recovery Steam Generator (HRSG) Application Engineer owns global, project-specific proposal activity to drive consistent functional specifications and standardized workflow…
Added 22 mins ago
Lead Field Service Engineer – Drives
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Unspecified, CT
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Added 22 mins ago
Lead Field Service Engineer – Automation
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Unspecified, CT
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Added 22 mins ago
Site Quality Lead / Staff Quality Engineer
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Guilford, CT
The Staff Quality Engineer serves as the Site Quality Lead and a member of the Site Leadership Team, providing strategic quality leadership across the product lifecycle. This role enables…
Added 22 mins ago
Sr HSE Engineer
Honeywell Technologies
Northford, CT
As a Senior HSE Engineer here at Honeywell, you will be responsible for overseeing and directing the organization's health, safety, and environmental engineering efforts. You will ensure…
Added 22 mins ago
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Senior Energy Engineer
Siemens
Cromwell, CT
- $92,589 to $158,725 USD / year
The Senior Energy Engineer conducts facility site visits, analyzes the customer’s current situation, and produces plans for Facility Improvement Measures (FIMs). This position also assists…
Added 22 mins ago
Lead Director Product Membership
CVS Health
Remote, United States
Direct Ownership of Core Retention Portfolios: Lead software, data engineering, Data Science, and Epic Analyst initiatives across key operational programs, including:
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Electrical Engineer Manager
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- $99,200 to $165,400 USD / year
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Added 22 mins ago
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Mechanical Engineer Manager
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Added 23 mins ago
GA
Sr Staff Applications Operations Engineer – Engineering Tools Automation & AI Ops
GE Aerospace
Norwalk, CT
- $131,000 to $174,000 USD / year
Serve as the senior technical operations authority across engineering application pods (software, hardware and electronic design, and project and portfolio management tools) for US and UK…
Added 23 mins ago
Spatial Metrology Engineer - CMM
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Danbury, CT
Support or lead, depending on experience, in the measurement optics in accordance with manufacturing documentation, process documentation and technical requirementsMeasuring components and…
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DevOps Engineer III
Deloitte
Hartford, CT
…and operational improvement to help organizations strengthen software delivery performance and business…
Added 23 mins ago
Software Engineer, Machine Learning RecSys
Meta
Hartford, CT
Software Engineer, Machine Learning RecSys Responsibilities:
Added 23 mins ago
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Java Full Stack Engineer with Spring boot/AWS Experience
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Hartford, CT
- $86,000 to $99,000 USD / year
As a Java Full Stack Engineer with Spring boot/AWS exp, you will make an impact by designing and delivering scalable, cloud-native healthcare payer applications that improve payment…
Added 23 mins ago
C
Java Full Stack Engineer with Spring boot/AWS Experience
Cognizant
Hartford, CT
- $86,000 to $99,000 USD / year
As a Java Full Stack Engineer with Spring boot/AWS exp, you will make an impact by designing and delivering scalable, cloud-native healthcare payer applications that improve payment…
Added 23 mins ago
Lead AI and Data Science Engineer II- Marketing Measurement
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Hartford, CT · Stamford, CT
…wants to work in a collaborative environment? As an experienced Lead AI and Data Science Engineer II - Marketing Measurement, you will have the opportunity to share new ideas and…
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OneStream Lead Analytics and Insights Engineer II Manager
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Lead the design and implementation of OneStream solutions for financial consolidation, planning, budgeting, and reporting
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Staff Software Architect
CVS Health
Hartford, CT
We are looking for a Staff Software Architect to serve as a technical leader within the Clinical Insights Engine team at CVS Health. This is a senior individual contributor role with…
Added 23 mins ago
EG
Cloud Engineer
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Hartford, CT
- $70 to $88 USD / hour
Our client seeks a senior Cloud Engineer to own and stabilize a legacy GCP and Azure footprint while assisting with conversions and decommissioning. The role will support automation efforts…
Added 31 mins ago
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Eliassen Group
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- $70 to $88 USD / hour
Our client seeks a senior Cloud Engineer to own and stabilize a legacy GCP and Azure footprint while assisting with conversions and decommissioning. The role will support automation efforts…
Added 42 mins ago
Engineering Manager
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Added 42 mins ago
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Closed listing

Abbott Laboratories

Senior Software Quality Engineer

Sylmar, CA, United States

The base pay for this position is $90,000.00 – $180,000.00.

This opening has closed.

The original listing is kept below for reference.

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Job details

Pay: The base pay for this position is $90,000.00 – $180,000.00.
Experience: Minimum 7 years of Software Quality Engineering experience.
Posting language: English
Posted: Nov 4, 2026

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Original job description

Archived listing. The details below describe a past opening.

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 122,000 colleagues serve people in more than 160 countries. 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. 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 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 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.

MAIN PURPOSE OF THE ROLE

This is an ONSITE role based out of Sylmar, CA

This position is responsible for software quality, compliance, and design assurance activities associated with cloud-based medical device applications and supporting infrastructure. This role ensures software systems are developed, verified, validated, and maintained in compliance with applicable medical device regulations, quality system requirements, cybersecurity standards, and design control processes. The position works closely with Development, Systems, DevOps, Product Management, Clinical Affairs, Cybersecurity, and Regulatory Affairs team to deliver secure, reliable, and compliant software solutions that support patient care and business objectives.

MAIN RESPONSIBILITIES

Support all phases of the Software Development Lifecycle (SDLC), including requirements development, architecture, implementation, verification, validation, release management, post-market support, and continuous improvement.
Review software lifecycle deliverables, participate in design and release reviews, and ensure software development activities align with Design Control requirements, software lifecycle standards, and risk management processes throughout the product lifecycle.
Participate in change impact assessments by evaluating the impact of software changes on product requirements, risk controls, testing, system performance, and regulatory compliance.
Assist in the completion and maintenance of risk management files, focused on software and system related risks.
Lead quality and compliance assessments for software defects and product issues, ensuring appropriate risk evaluations, impact assessments, and escalation processes are executed to support timely customer communications, regulatory reporting evaluations, and corrective action activities
Evaluate verification and validation strategies, test coverage, traceability, and defect management activities to ensure requirements, risk controls, cybersecurity considerations, and intended use are adequately addressed and supported by objective evidence for compliant product releases
Support internal audits, external audits, regulatory inspections, and compliance assessments by providing objective evidence and subject matter expertise related to software lifecycle and design control processes.
Drive continuous improvement activities and support investigations, CAPAs, and compliance initiatives related to software products and processes.
Serve as a software compliance and design assurance subject matter expert, partnering with cross-functional teams to ensure quality and compliance considerations are integrated throughout product development and maintenance activities.
Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
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.

QUALIFICATIONS

Education

Bachelors Degree (± 16 years) in an Engineering or Technical Field

(OR)

An equivalent combination of education and work experience

Experience/Background

Minimum 7 years of Software Quality Engineering experience.
Detailed knowledge of IEC 62304, ISO 14971, ISO 13485, FDA Design Controls, FDA Computer Software Assurance (CSA), Medical Device Cybersecurity Guidance, Software Validation Principles, IEEE 1012.
Advanced computer skills, including statistical/data analysis and report writing skills.
Advanced Information Technology and data mining skills.
Prior medical device experience preferred. ASQ CSQE certification desired.
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 travel approximately 5-25%, including internationally.

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.

About employer

More about this job

Skills

Abbott
Regulatory compliance
Medical device regulations
Cybersecurity
Regulatory affairs
Patient care
Software development
Process improvement
Risk management
Product comprehension
Reporting
Internal auditing
Inspection
Quality assurance procedures
EMS
Collaboration
Computer skills
Data analysis
Report writing
Computer technology
Data mining
Attention to detail

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