Senior Verification Engineer

Full Spectrum; Boston (MA); On-site; USD 90,000 - 165,000; Full time

Job summary

Full Spectrum is seeking a Senior Verification Engineer to lead V&V efforts for medical device software and hardware. You will plan, develop, and execute verification tests across software, hardware, GUI, and back-end components, ensuring compliance with FDA design controls and IEC 62304.

You will write comprehensive test plans and protocols, manage risk analyses and FMEA-related test failures, and collaborate with clients to deliver high-quality, compliant solutions on schedule.

Qualifications

• 5–10 years of experience as a verification engineer.
• Experience with FDA-regulated medical products testing.
• Knowledge of ISO 13485 and IEC 62304 standards.
• Ability to plan V&V activities and map test types.
• Experience with risk analysis and FMEA related to test failures.
• Familiarity with test protocol creation and documentation.

Responsibilities

• Estimate, plan, develop, and maintain manual test cases and protocols.
• Write documentation including testing plans and verification protocols.
• Execute test cases across multiple environments.
• Perform software, hardware, GUI, and back-end testing.
• Design functional tests based on system specs.
• Collaborate with project management to meet milestones.
• Ensure FDA-regulated products are tested per ISO 13485 and IEC 62304.
• Manage client relationships and contribute to improvement of verification practices.

Skills

V&V planning

FDA design controls

IEC62304

Test case development

LabVIEW

Agile development

Risk analysis & FMEA

Test automation

Tools

LabVIEW

Job description

Technology has never been more present in our lives than today. Everything from connected medical devices to robotics to mobile apps are becoming more a part of daily life. A career at Full Spectrum will allow you to be at the cutting edge of engineering driven innovation. If it excites you to develop new products and learn new technologies on a regular basis from a diverse set of customers, then this is the place for you.

We have a passionate team of experienced professionals who have first-hand experience developing products. Our clients are dependent on us to develop their next innovative product to bring to market. Come help us build the future, come join Full Spectrum!

Sr. Verification Engineer:

A Verification Engineer is a technical position responsible for testing and verification of software as a medical device, medical device systems and software embedded medical devices. Verification Engineers are responsible for V&V planning, mapping of test types, associating design requirements into test groups, developing test method and test cases to verify requirements, creating protocols and execution/documentation of verification tests within schedule constraints, meeting quality standards and goals.

ROLE RESPONSIBILITIES:

· Estimate, plan, develop, execute, and maintain manual test cases and test protocols for products under development.

· Writing skills to develop documentation including testing plans, detailed test cases, and verification protocols.

· Work with different Test Environments to execute the test cases.

· Perform Software, Hardware, Application, GUI and/or Back-End testing.

· Design and develop functional tests based on system specifications.

· Work with project management to meet the testing milestones and deliver high quality solutions on time.

· Ensure that FDA-regulated medical products are tested in adherence to the applicable standards, regulations (ISO 13485, IEC 62304) and best practices.

· Manage relationships with clients

· Contributing to the continuous improvement of verification engineering practices

· Identify opportunities to drive further value in client engagements

· Reviewing risk analysis and experience working on FMEA’s as it relates to test failures

· Understanding of FDA design controls and Software V&V for medical devices

· Understanding of standards impacting verification of medical devices such as IEC62304

· Understanding of issue tracking, issue tracking process and management of issues list in a bug tracking tool

· 5-10 years experience as a verification engineer

PREFERRED EXPERIENCE:

·Test case and protocol development for medical device applications. Experience writing formal test reports that meet Good Documentation and Lab practices.

· Experience writing test scripts with creating Automated Test cases a plus.

· Experience with software or medical devices that have been reviewed or certified by test houses or notified bodies.

· Use of LabVIEW or similar environment to aid in verification of systems. Author automated Test Scripts a plus.

· Knowledge, Skills and Abilities:

· Writing test cases, protocols

· Test case development for GUI and GUI workflows

· Negative and positive testing for functional test cases

· Test planning, protocol writing

· Test report writing.

· Requirements review an allocation

· V&V planning experience

· Test tools and test automation experience

· Understanding of software Development lifecycle and Agile development

· IEC62304

· Performance testing medical device systems

· Statistics experience, sample size determination

The base salary for this position is $90,000 to $165,000 annually, and the role is bonus eligible.

Thefinalsalaryofferisdeterminedbyfactorssuchasexperience,location,skills,education,andmarketconditions.**