Associate Product Assurance Engineer - (On Site)

Onsite in Somerset, PA. Visa sponsorship is not available.

About the role

Validation and verification activities for design & development and regulatory product launch of respiratory medical products.

Responsibilities

• Create new or modify existing testing plans to ensure compliance to internal and customer requirements, the FDA Quality System Regulation, and the Medical Device Directive.
• Provide expertise regarding software testing methods, techniques, and tools to develop testing procedures appropriate for medical device software development and manufacturing, including selecting appropriate manual, scripted, or automated solutions to conduct testing.
• Execute the verification and validation testing of software, embedded firmware, and hardware used in electromechanical and disposable medical devices to ensure rigorous product testing, including tests for: functional safety, system level integration, mechanical operation, environmental conditions, reliability, performance/load, failure modes, and usability.
• Participate in design activities to achieve a high level of testability in final product designs.
• Ensure all input documents, protocols, and test reports for verification and validation processes are compliant to domestic and international regulatory agencies.
• Ensure that verification and validation activities are completed on time as per schedule.
• Prepare formal verification and validation test reports using applicable safety standards.
• Demonstrate customer focus, cross-functional collaboration/teamwork skills, continuous innovation and improvement, and sound judgment.
• Analyze product and sub-system requirements.
• Analyze and verify medical device designs.
• Write detailed procedures that test for success, failure, and integration/performance testing.
• Conduct statistical analysis of test results.
• Maintain and control test execution records using good lab practices.
• Provide support for establishing Risk Management File and Usability Engineering requirements.

Requirements

• Bachelor’s degree in engineering or a scientific field required or equivalent work experience.
• Minimum of 1 to 2 years of relevant technical experience is required.
• Proficiency in preparing formal technical reports is required.
• Experience with PC software including Microsoft Excel and Word is required.
• A working knowledge of quality system standards and regulations is required; experience with the FDA Quality System Regulation and ISO-13485 is preferred.
• Experience analyzing device requirements and developing test plans and test procedures to verify those requirements is required.
• Experience working in a System Testing or Product Assurance function within an FDA or similarly regulated environment is preferred.
• Experience with Risk Management activities (hazard analysis, FMEA) and reliability analysis preferred.
• A working knowledge of device safety testing requirements and standards (like IEC 60601-1, 60601-2, 60601-11).
• Knowledge of statistical analysis techniques for test data is preferred.
• Experience handling multiple concurrent project assignments is preferred.

Skills

• Strong written, persuasion, consensus building, listening, and verbal communication skills.
• Team-oriented and capable of working in a multi-disciplinary and creative environment.
• Highly motivated and capable of setting and achieving goals with minimal supervision.
• Proficiency with MS Office applications.

Benefits

• Competitive benefits package.
• Paid Time Off.
• 401(k) Savings Plan.