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QuidelOrtho · 3 days ago

Senior Software Instrument Verification and Validation Engineer (Lead)

Rochester, NY

Full-time

Onsite

Senior Level, Lead/Staff

$95K/yr - $110K/yr

5+ years exp

QuidelOrtho is a leading in vitro diagnostics company, formed by the unification of Quidel Corporation and Ortho Clinical Diagnostics. They are seeking a Senior Software Instrument Verification and Validation Engineer to lead verification and validation efforts for complex medical devices, ensuring compliance with FDA regulations and collaborating with cross-functional teams.

Medical Device

No H1B

Responsibilities

Manage V&V resources with testing and debugging system software, serving as a technical bridge between software Development and V&V

Ensures rigorous adherence to design control documentation and internal procedures for post-launch activities, maintaining regulatory compliance and product quality standards

The development of requirements-based manual test procedures

Compilation and analysis of test results

Documentation and management of system software defects

Lead in regular scheduling, planning, resourcing, and team meetings

Participate in regular off-hour meetings with the business partner

Understand project goals and timelines, and provide technical leadership to ensure product launch success

Ensures optimal resource allocation and timely project completion while maintaining quality standards

Provides critical oversight in resolving field issues and maintaining product integrity throughout the lifecycle

Mentor and develop team members to help them grow professionally

Perform other work-related duties as assigned

Qualification

Instrument V&V TheoryIEC 62304ISO 13485FDA QSR experienceSoftware configuration managementDefect tracking toolsProduct development toolsExperimental designAnalytical skillsAgile method knowledgeTest plansCases writingOrganizational skillsCross-functional teamworkCommunication skillsProject management

Required

B.S. or M.S. Degree in Computer Science, Chemistry, Biochemistry, Biology, Engineering, or a related discipline required

Minimum of 5 years required, preferably leading in a medical device environment

Strong knowledge of software configuration management tools, defect tracking tools, and peer review

Strong understanding of Instrument V&V Theory & Application

An understanding of IEC 62304 (Medical Device Software – Lifecycle process), ISO 13485, ISO / EN ISO 14971, and FDA QSR experience or equivalent FDA software development requirements

Strong analytical and problem-solving skills

Strong organizational skills and the ability to manage multiple tasks

Experience in product development and experimental design

Ability to work within cross-functional teams

Strong communication skills, written and verbal

Must exhibit professionalism, confidence, maturity, desire to succeed, and a self-motivated and proactive orientation

Ability to participate in planning and managing projects

Strong working knowledge of product development tools and processes (e.g., Design Input, Design Output, Verification and Validation, Product Risk Management)

Strong knowledge of related quality systems regulations and processes

Appropriate computer skills (e-mail, word processing, statistical, spreadsheet, and graphing software)

Knowledge of Application life cycle management (Agile method preferred)

Must know and understand the software test cycle

Must have the ability to write test plans, test cases, and test reports

The 10% travel includes airplane, automobile travel, and overnight hotel Include title, an overview of the position, and location (onsite, hybrid, on the road, etc)

This position is not currently eligible for visa sponsorship

Benefits

Medical

Dental

Vision

Life

Disability insurance

401(k) plan

Employee assistance program

Employee Stock Purchase Plan

Paid time off (including sick time)

Paid Holidays

Company

QuidelOrtho

Glassdoor3.5

> Bringing precision and passion in everything we do QuidelOrtho stands at the forefront of testing, tracking and disease analysis of health conditions ranging from HIV and hepatitis C to flu, strep and COVID-19.

Founded in 1937

5001-10000 employees