Associate Product Assurance Engineer, Medical Devices

Drive Medical; Somerset (Somerset County); On-site; USD 70,000 - 100,000; Full time

Benefits offered by this job

Competitive Benefits

Paid Time Off

401(k) Savings Plan

Job summary

Drive Medical in Somerset, PA is seeking a Validation Engineer to lead verification and validation activities for design, development, and regulatory product launches of respiratory medical devices.

You will create testing plans, execute V&V of software, firmware, and hardware, ensure compliance with FDA QSR and ISO 13485, document results, and collaborate across functions to improve testability and risk management. Minimum 1–2 years of experience and a bachelor’s in engineering required.

Qualifications

• Bachelor’s degree in engineering or a scientific field, or equivalent work experience.
• 1–2 years of relevant technical experience.
• Proficiency in preparing formal technical reports.
• Experience with FDA Quality System Regulation and ISO 13485 preferred.
• Experience with risk management (hazard analysis, FMEA) and reliability analysis preferred.

Responsibilities

• Create new or modify testing plans to ensure compliance with internal/customer requirements and regulatory standards.
• Provide expertise on testing methods, techniques, and tools for medical device software development and manufacturing.
• Execute verification and validation testing of software, embedded firmware, and hardware for electromechanical and disposable devices.
• Participate in design activities to improve testability of final product designs.
• Prepare formal verification and validation test reports per applicable safety standards.
• Ensure test records and reports comply with domestic and international regulators.
• Demonstrate collaboration, customer focus, and continuous improvement.

Skills

Software testing

Test planning

Statistical analysis

Documentation

Education

Bachelor’s degree in engineering or a scientific field

Tools

Microsoft Excel

Microsoft Word

MS Office

Job description

Drive Medical in Somerset, PA is seeking a Validation Engineer to lead verification and validation activities for design, development, and regulatory product launches of respiratory medical devices.

You will create testing plans, execute V&V of software, firmware, and hardware, ensure compliance with FDA QSR and ISO 13485, document results, and collaborate across functions to improve testability and risk management. Minimum 1–2 years of experience and a bachelor’s in engineering required.