Full-Time

Software Quality Engineer 2

Masimo

Masimo

1,001-5,000 employees

Noninvasive patient monitoring devices and wearables

Compensation Overview

$75k - $100k/yr

+ Annual Bonus

Irvine, CA, USA

In Person

Bachelor's, Master's

Category
QA & Testing
Required Skills
Agile
Software Testing

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Requirements
  • Bachelor’s degree in Computer Science, Software Engineering, Electrical Engineering, Biomedical Engineering, or related technical discipline.
  • Minimum 3 years of experience in Quality Engineering, Quality Assurance, or Software Quality within a regulated industry.
  • Working knowledge of software development lifecycle (SDLC), Agile and/or waterfall development methodologies.
  • Experience supporting software verification and validation activities.
  • Knowledge of medical device regulations and standards such as FDA 21 CFR Part 820, ISO 13485, IEC 62304, and ISO 14971.
  • Experience with change control, nonconformance, CAPA, and complaint handling processes.
  • Strong analytical, problem-solving, and risk assessment skills.
  • Strong written and verbal communication skills with the ability to work cross-functionally.
  • Proficiency with Microsoft Office applications and quality documentation systems.
Responsibilities
  • Partner with software development and cross-functional teams to ensure quality is integrated throughout the software development lifecycle.
  • Review and approve software development deliverables including requirements, architecture, risk documentation, test protocols, traceability, and validation records.
  • Support design control activities in compliance with applicable regulations and standards, including FDA 21 CFR Part 820, ISO 13485, IEC 62304, ISO 14971, and other applicable global requirements.
  • Participate in design reviews, phase gate reviews, and change control activities for software-based products and systems.
  • Review software verification and validation activities including unit, integration, system, cybersecurity, and user acceptance testing.
  • Support software risk management activities, including hazard analysis, failure mode assessments, and risk control verification.
  • Evaluate software defects, nonconformances, and quality events to determine product impact and required actions.
  • Participate in CAPA, complaint investigations, post-market surveillance, and field issue assessments involving software-related products.
  • Support internal audits, external audits, and regulatory inspections by preparing documentation and providing subject matter expertise.
  • Drive continuous improvement initiatives to strengthen software quality systems, processes, and compliance effectiveness.
  • Assist in the creation, review, and maintenance of Design History Files (DHF), Device Master Records (DMR), and quality records.
  • Mentor junior team members and provide guidance on software quality processes and best practices as needed.
  • Perform other duties or special projects as assigned.
Desired Qualifications
  • Experience supporting Software as a Medical Device (SaMD), embedded software, connected devices, or cybersecurity-focused products.
  • Experience with automated test tools, defect tracking systems, or application lifecycle management systems.
  • Certified Quality Engineer (CQE), Certified Software Quality Engineer (CSQE), or equivalent certification.
  • Experience in the medical device industry strongly preferred.
  • Master’s degree in a related technical discipline.

Masimo is a global medical technology company that develops, manufactures, and markets noninvasive patient monitoring technologies for the healthcare sector. Its core offerings include the Root patient monitoring and connectivity platform and the Masimo W1 health-tracking wearable with FDA-cleared modules, reflecting a focus on noninvasive monitoring and consumer health wearables. The company expanded into consumer electronics by acquiring Sound United, enabling products that deliver personalized, lossless sound alongside health data capabilities. Its goal is to improve life by enhancing patient monitoring and delivering high-quality sound experiences, bridging healthcare with everyday health and wellness.

Company Size

1,001-5,000

Company Stage

IPO

Headquarters

Neuchâtel, Switzerland

Founded

1989

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Simplify Jobs

Simplify's Take

What believers are saying

  • June 2026 Radius VSM clearance expands Masimo into continuous wearable monitoring.
  • Pediatric PSi FDA clearance broadens SedLine adoption in surgery and intensive care.
  • Danaher's global salesforce can push Masimo's monitoring platforms into more hospitals worldwide.

What critics are saying

  • Danaher closed the $9.9 billion deal on June 10, 2026, ending Masimo independence.
  • Integration under Danaher and CEO turnover can stall innovation through 2027.
  • Apple keeps fighting Masimo patents, and Customs rulings could erode licensing leverage.

What makes Masimo unique

  • Masimo's SET pulse oximetry remains the hospital standard, now inside Danaher Diagnostics.
  • June 4, 2026 FDA clearance gave Radius VSM arrhythmia-aware monitoring credibility.
  • Masimo still owns defensible Apple-related pulse-oximetry IP after the November 2025 verdict.

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Benefits

Health Insurance

Dental Insurance

Vision Insurance

Life Insurance

Disability Insurance

401(k) Retirement Plan

401(k) Company Match

Paid Vacation

Paid Sick Leave

Paid Holidays

Paid Maternity Leave

Health Savings Account/Flexible Spending Account

Flexible Work Hours

Pet Insurance

Wellness Program

Gym Membership

Growth & Insights and Company News

Headcount

6 month growth

0%

1 year growth

0%

2 year growth

4%
PR Newswire
Jul 27th, 2026
Masimo gets FDA clearance for first sedation score designed for children's brains

Masimo, a Danaher company, has received FDA 510(k) clearance for the Pediatric Patient State Index (PSi), the first sedation score designed specifically for children's brain physiology. The technology monitors depth of sedation in patients aged four and older during surgery and intensive care. Pediatric PSi is the only index derived from bilateral brain data and indicated for use with both propofol and sevoflurane anaesthetics. The clearance follows clinical data from 169 paediatric patients showing the algorithm's effectiveness in tracking sedation stages and detecting burst suppression, a sign of potential oversedation. Masimo SedLine, first cleared for paediatric use in 2022, monitors brain activity through electroencephalogram signals from both brain halves. The technology addresses challenges in paediatric sedation monitoring, as children's brains respond differently to anaesthesia than adults'.

MedTech Dive
Jun 25th, 2026
BD's Bilal Muhsin talks AI in connected care.

BD's Bilal Muhsin talks AI in connected care. Muhsin discussed how BD is rolling out a new medication dispenser and a software platform that pulls together data from the company's various devices. Published June 25, 2026 - Updated 5 hours ago Since Bilal Muhsin joined BD last year as president of its connected care business, the former Masimo chief operating officer has overseen the launch of key data and artificial intelligence initiatives designed to assist clinicians monitoring patients in the hospital. The connected care segment includes patient monitoring systems and medication management, including BD's Pyxis automation medication dispensing systems and Alaris infusion pumps. BD received a warning letter from the Food and Drug Administration in 2024 related to its Pyxis dispensers. The company told MedTech Dive that it has completed commitments to the FDA and is working with the agency toward a resolution. Last fall, BD launched in the U.S. a new version of its Pyxis dispenser, Pyxis Pro. The company also rolled out a new AI platform, called Incada, that pulls together data from BD's various devices. MedTech Dive spoke with Muhsin to catch up on his new role, the recent device launches and BD's approach to AI. This interview has been edited for length and clarity. MEDTECH DIVE: What has your focus been since you joined BD last year? BILAL MUHSIN: I joined BD because of a purpose. The connected care segment is extremely intriguing, because Medtech Dive is the only company in the world that knows what's going into the body from its Pyxis solution: What's being dispensed into that patient for oral medications or is being infused into them through its pumps. Medtech Dive also have the monitoring capability, so Medtech Dive know what's going into the patient and what's happening in real time. With that kind of information, Medtech Dive can have a huge impact. That's what really got me excited about a year ago. How are you looking to connect these systems? One example [is] Medtech Dive can look at between its infusion pumps and its advanced patient monitoring. Medtech Dive know what's happening in that patient in real time from a blood pressure standpoint, and if a clinician is providing a blood pressure medication to that patient and is expecting the blood pressure to either go up or down, and it's not doing that, Medtech Dive can immediately intervene. Or, better yet, if they want to titrate medication for that patient, Medtech Dive can now titrate it, not based on the clinician walking in the room [and] looking at the monitor. If Medtech Dive want to titrate up or titrate down that medication based on a physiological response that is coming from that patient, Medtech Dive can now automate that entire process and save a lot of clinician time. What types of technologies are you using to accomplish this? Is it machine learning, generative AI, etc.? Medtech Dive has different types of problems Medtech Dive can solve, and Medtech Dive will use different types of models to solve those problems. When it comes to workflow enhancements, Medtech Dive has a lot of what's happening with medication management across the hospital system. In those cases, Medtech Dive can let agentic [AI] come in, play a big role, provide insights and actually take action on how to manage inventory, for example. For solutions that are more clinical in nature, here Medtech Dive want to be a lot more careful, and Medtech Dive always want to have a clinician in the middle. Medtech Dive has a lot of machine learning algorithms. Medtech Dive has already launched a lot of predictive notifications that come onto its advanced patient monitoring solutions today. So Medtech Dive can predict before somebody goes into hypotension 15 minutes before. Those things, Medtech Dive has been getting regulatory clearance and shipping into market today. As Medtech Dive advance more into that, Medtech Dive want the clinician to stay in the middle. As Medtech Dive talk about alerts, how do you find the balance between making something helpful and avoiding alarm fatigue? When you look at nurse time and what it's spent on, a lot of it's spent on alarms coming from the monitor or alarms coming from the pump. Mostly, everything's threshold-based alarms. There's a trigger that occurs based on a value increasing or decreasing beyond a certain number. As this model of patient data gets more advanced, Medtech Dive is looking at a lot more parameters at the same time, and now Medtech Dive can predict whether the patient is actually going in a certain direction or is stable and just moved for a second or took off the sensor. There are ways to know, is this a true deterioration that is occurring to the patient that Medtech Dive need a nurse to walk into, or is this something that's going to be episodic in nature and disappear really quickly? As Medtech Dive track more and more of the data, and as Medtech Dive become more predictive in what Medtech Dive is doing, Medtech Dive should actually reduce the number of alarms. The idea is, as this gets smarter, to eventually eliminate these threshold-based alarms, because these smarter alarms will come through and they'll be much more actionable for the clinicians. What information are you providing to clinicians with these alerts? What Medtech Dive want to do is be transparent in terms of what's causing these things to trigger. So not only are Medtech Dive saying, hey, there's a deterioration that is occurring for this patient, but here are the four or five things that are highly factoring into the reason why Medtech Dive is saying that. If you want to dig more, Medtech Dive can give you more. There's also an issue of having too much information. You see all these massive dashboards go up in hospitals, and everybody gets lost, and Medtech Dive want to actually simplify.

Yahoo Finance
Jun 24th, 2026
Danaher acquires Masimo for $9.9B to expand into patient monitoring despite 22% stock decline

Danaher, a life sciences and diagnostics company, has fallen 22% this year following its $9.9 billion acquisition of Masimo, a leader in non-invasive patient monitoring. The deal raised investor concerns about a patent dispute with Apple and increased debt levels. The acquisition is expected to add $0.15 to $0.20 to adjusted earnings per share in its first year, scaling to $0.70 by year five. Danaher has raised its 2026 adjusted EPS guidance to $8.35–$8.55. In the first quarter, Danaher reported revenue of $5.95 billion, up 3% year over year, and EPS of $1.45, up 9.8%. The company is seeing 30% year-over-year growth in equipment orders, driven by reshoring trends and renewed interest in life sciences as pharmaceutical companies invest to strengthen their pipelines.

JH Consulting Online
Jun 23rd, 2026
QuidelOrtho names new C-suite executive.

QuidelOrtho names new C-suite executive. June 23, 2026- QuidelOrtho Corporation announced the appointment of Micah Young as Chief Financial Officer, effective July 6, 2026. Mr. Young will succeed Joseph M. Busky, who previously announced his retirement as Chief Financial Officer and will serve in an advisory role to support a smooth transition. Mr. Young most recently served as Executive Vice President and Chief Financial Officer of Masimo Corporation, a global medical technology company. He joined Masimo as CFO in 2017 and helped lead the company through a period of strategic transformation, operational improvement, disciplined capital allocation, enhanced investor engagement and significant transaction activity. Previously, he held progressively senior finance roles at NuVasive, Inc. and finance and accounting roles at Zimmer Holdings, Inc., after beginning his career at Deloitte & Touche LLP. Mr. Young holds a Bachelor of Science in Accounting and Criminal Justice from Indiana Wesleyan University and is a Certified Public Accountant (inactive).

Associated Press
Jun 22nd, 2026
Masimo receives FDA clearance for AI-enabled opioid overdose detection on wearable monitor

Masimo, a Danaher company, has received FDA 510(k) clearance for an AI-enabled opioid-induced respiratory depression detection feature integrated into its Radius VSM wearable patient monitor. The technology uses advanced pattern recognition to analyse continuous physiological data, helping clinicians identify early signs of respiratory compromise in hospital patients receiving opioid therapy. The clearance marks the first implementation of Masimo's OIRD detection capability in a hospital monitoring solution. Using the company's smartSET pulse oximetry sensor platform, the feature analyses complex physiological patterns rather than individual parameters alone. The OIRD detection includes visual alarms that alert clinicians to changes in patient condition and can be relayed to remote monitoring stations. Masimo is developing additional pattern-recognition algorithms for the smartSET platform.