Validation Engineer

Fives DyAG Corp.; Boxborough (MA); On-site; USD 80,000 - 105,000; Full time

Job summary

Creative Solutions Services, LLC is seeking a Test Engineer to qualify automated functional testers and execute the corresponding validations in a regulated medical-device environment.

The role involves writing comprehensive documentation, including requirements, trace matrices, protocols and reports, and collaborating with internal teams to ensure systems meet IQ/OQ/PQ standards. Hardware assembly support may be required.

Qualifications

• Bachelor's degree in Engineering or related discipline required.
• Experience in verification/validation testing in medical devices or regulated industries.
• Familiarity with automated test systems and documentation best practices.
• Strong analytical, documentation, and problem solving skills.
• Experience as tester development for manufacturing environments.
• Experience with validations within MFG environments - IQ/OQ/PQ.
• Bonus: background in Test Stand LabVIEW to aid debugging and tracing requirements.

Responsibilities

• Test Stand & LabVIEW experience with manufacturing equipment validations (IQ/OQ/PQ).
• Qualify automated functional testers and support troubleshooting.
• Write all documentation (requirements, trace matrices, protocols, reports) using healthcare templates.
• Collaborate with internal resources to complete paperwork and qualify systems.
• Assist in assembling hardware side of testers as needed.
• Develop and maintain validation documentation and test protocols.

Skills

Functional Testing

Documentation

Problem solving

Analytical

Education

Bachelor's degree in Engineering

Tools

Test Stand

LabVIEW

IQ/OQ/PQ

Job description

Roles & Responsibilities :

• Test Stand & LabView experience along with some Manufacturing equipment validations (IQ/OQ /PQ) experience


• Test Engineer that can help qualify Automated Functional Testers.


• Would be responsible for writing all the documentation (requirement| trace matrix| protocols| reports using the Healthcare templates) and executing the validations.


• The code for the testers will be written by an internal resources with whom Candidate would work closely in order to complete the paperwork and qualify the systems.


• Candidate may also help assemble the hardware side of the tester.


• Good To have - Background in Test Stand | LabView that would be a bonus to help debug and trace requirements.


• Qualify automated functional test systems and support troubleshooting.


• Develop and maintain validation documentation| including requirements| trace matrices| test protocols| and reports.


• Execute verification and validation testing| document results| and manage deviations.


• Ensure compliance with internal quality systems and regulatory standards.


• Collaborate with cross functional teams to support product testing and continuous improvement.

Requirements:

• Bachelors degree in Engineering or related discipline.


• Experience in verification validation testing| preferably in medical devices or other regulated industries.


• Familiarity with automated test systems and documentation best practices.


• Strong analytical| documentation| and problem solving skills.


• About Client Medical device customer USP of the Role and Project


• Would be responsible for writing all the documentation (requirement| trace matrix| protocols| reports using this.


• The code for the testers will be written by an internal resources with whom this person would work closely in order to complete the paperwork and qualify the systems.


• They may also help assemble the hardware side of the tester.


• Candidate should have experience as tester development for Manufacturing


• Candidate should have experience with the validations within the MFG environment - IQ| OQ| PQ


• Responsible for writing all the documentation (requirement| trace matrix| protocols| reports using the Healthcare templates) and executing the validations.


• If they have background in Test Stand LabView that would be a bonus to help debug and trace requirements.


• Essential Skills: Functional Testing


• Skills: Functional Testing


• Skills: MFG/PRO Domain (QAD)


• Experience Required: 4-6