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New · posted Oct 15

Prolaio · Medical Devices

Lead Software Quality Engineering, Backend

  • Chicago, IL
  • On-site
  • Full-time
  • Senior & Principal
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EmploymentFull-time
Deadline

Open until filled

The role

The Backend Software Quality Engineering Lead will oversee and actively contribute to the validation and verification of our cloud-based data platform. In this role, you will act as a true player-coach—balancing technical leadership, team mentorship, and direct individual contribution. You will be responsible for the integrity of our high-volume data pipelines and backend services, leading a small team of automation test engineers while also contributing to test case automation and executing test strategies.

This role is ideal for a technical leader who wants to guide a team and handle management responsibilities, but prefers to remain an active contributor rather than stepping into a pure management role. You must be ready to quickly adopt existing automation frameworks, identify opportunities for optimization, and drive the requirements-gathering process to ensure clinical safety in a Software as a Medical Device (SaMD) environment.

Who Are We?

Prolaio believes that continuous learning and collaboration can make a significant difference in how heart care is administered. We are creating smarter ways to address heart disease and heart risks by uniting patients, care teams, and researchers on a secure, technology-enabled platform that drives clinical innovation and offers a path towards better patient outcomes.

This is precision cardiology, and we know it’s within reach.

The Specifics

  • Hands-on Leadership & Mentorship: Lead, coach, and mentor a team of backend automation engineers by example. You will handle light management responsibilities (defining roadmaps, professional development) but will split your time between leadership and active technical contribution (writing test code, reviewing PRs, and executing tests).
  • Active Framework Evolution: Quickly master and directly contribute code to our existing backend test frameworks. You will be hands-on in maintaining, scaling, and optimizing these tools, ensuring they remain performant as our cloud infrastructure evolves.
  • Requirements Engineering: Act as a collaborative bridge between Product, Engineering, and Regulatory teams. You will use your experience to translate complex clinical needs into actionable, testable verification plans, actively writing test cases that ensure full feature coverage.
  • Data & Analytics Validation: Design and execute strategies to validate large-scale analytical data warehouses and NoSQL storage layers (e.g., BigQuery, Cassandra). You will be personally responsible for verifying the accuracy of complex datasets, specifically focusing on the precision of time-series data.
  • Regulatory Alignment: Oversee and participate in the verification (V&V) process to ensure our cloud services meet SaMD standards (e.g., ISO 13485, IEC 62304), ensuring automated testing provides the necessary evidence for regulatory compliance.

What you need

  • Technical Leadership: 8+ years in backend testing or software development, with a proven track record of blending hands-on technical contribution with team mentorship or formal lead experience. You prefer leading by example from within the code, rather than managing from a distance.
  • Automation Mastery: Demonstrated ability to write clean code and improve existing automation frameworks (e.g., Python, Kotlin, or Java) while knowing when to build new components from scratch.
  • Cloud Backend Expertise: Deep, practical experience testing cloud-native services and API architectures.
  • Advanced Data Proficiency: Expert-level SQL skills and extensive practical experience validating high-scale data environments, including analytical warehouses and NoSQL databases.
  • Temporal Data Experience: Proven ability to validate time-series data and complex data streams, ensuring consistency and integrity over time.
  • Requirements & Design: Strong background in requirements engineering, with the ability to analyze a feature at the design stage and ensure it is architected for testability and safety.

Additional Qualifications (Nice to Haves)nice to have

  • Previous experience in a regulated industry (Healthcare, MedTech, or BioTech).
  • Familiarity with Risk Management (ISO 14971) as it informs test case prioritization.
  • Experience with CI/CD integration and cloud monitoring/observability tools.

Pay and benefits

$150,000 a year

Employer provided
How this compares

Starting Salary is at $150,000.00 (Exact Compensation may vary based on skills, experience, and location)

  • Performance bonus and equity

  • Medical, dental and vision plans

  • HSA, FSA and commuter benefits

  • $1,200 annual Lifestyle Spending Account

  • Paid time off and paid parental leave

  • 401(k) plan

Where you'll work

Chicago, ILOn-siteOpen in Maps (opens in a new tab)

More jobs in Chicago, IL

From the posting

About Prolaio

Why Prolaio?

  • Impactful Work: You will join in the fight against heart failure (HF) and hypertrophic cardiomyopathy (HCM) with the goal of extending and saving the lives of our patients while also being at the forefront of changing the healthcare industry through technology.
  • Innovative Environment: You will be part of an organization doing something that’s never been done before.
  • Professional Growth: You will join a growing team and have a substantial impact on our daily and future operations with the opportunity to continuously learn and grow.
  • Collaborative Team: You will be part of a team of collaborative, curious, and committed individuals focused on the collective good, inclusiveness, scientific excellence, and advancing digital health for cardiology.

Why You’ll Love Working Here

  • Meaningful Compensation: Competitive salary, performance bonus, and equity so you can share in what we build.
  • Great Health Coverage: Medical, dental, and vision plans with multiple options and strong company contributions.
  • Flexible Spending Perks: HSA, FSA, commuter benefits, and a $1,200 annual Lifestyle Spending Account to support wellness, commuting, family needs, and more.
  • Time to Recharge: Generous paid time off, sick leave, and company holidays.
  • Family-First Benefits: Paid parental leave, caregiver leave, and support for growing families.
  • Security & Peace of Mind: Company-paid life insurance and short- and long-term disability coverage.
  • Plan for the Future: 401(k) plan to help you build long-term financial security.
  • Care When You Need It: Easy access to telehealth and optional supplemental coverage for life’s unexpected moments.
Prolaio company page · 1 open role

Job intelligence

The context around this role

Live data · October 15, 2026

Salary intelligence

How the pay compares

This role's midpoint is 24% above the US median for Validation & CQV roles at this level.

This roleEmployer provided

$150,000 to $150,000 a year

Senior & Principal roles in the US47 roles publishing pay

Middle half $110,750 to $132,500, median $121,000
Annual base pay
Annual base payLowMedianHigh
This role$150,000—$150,000
All US$110,750$121,000$132,500

This role: Prolaio's own published range. Comparisons: the base pay employers published on open Validation & CQV roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.

Career trajectory

Where this role sits in Validation & CQV

The general path across 111 open Validation & CQV roles on Regulatory Jobs, with the titles they carry most. Not Prolaio's own promotion track.

  1. One step back

    Associate & Specialist

    Often: Associate QA Validation Specialist · Engineer II, Validation

    $77K median25 open
  2. This role

    Senior & Principal

    Often: Engineer III, Validation · Senior Engineer, Validation

    $121K median64 open
  3. Next step

    Manager

    Often: Validation Manager · Manager, Computer Systems Validation

    $141K median15 open
  4. Later

    Director

    Often: Associate Director, Validation · Associate Director, Computer Systems Assurance

  5. Later

    VP & Executive

    Often: Head of Validation & Risk Management

Skills DNA

What this role leans on

How many of the posting's 18 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.

GMP and compliance: 1 lineLab testing and methods: 11 linesDocumentation and SOPs: 3 linesValidation and qualification: 4 linesQuality systems and risk: 2 linesData and digital systems: 3 linesCollaboration and leadership: 6 linesGMPLab testingDocumentationValidationQuality systemsData systemsTeamwork
  • Lab testing and methods11
  • Collaboration and leadership6
  • Validation and qualification4
  • Documentation and SOPs3
  • Data and digital systems3
  • Quality systems and risk2
  • GMP and compliance1

Company hiring pulse

Prolaio on Regulatory Jobs

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Similar Validation & CQV roles elsewhere

Lead Software Quality Engineering, Backend at Prolaio

Open until filled. $150K a year, employer provided.

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    Lead Software Quality Engineering, Backend at Prolaio — Chicago, IL | Regulatory Jobs