Onsite in Somerset, PA

NO VISA SPONSORSHIP

Reports to (title): Manager, Product Assurance

Department: Clinical Care Engineering

FLSA Status: Exempt

Who is Drive Medical...

Drive Medical has become a leading manufacturer of medical products with a strong and consistent track record of growth achieved both organically and through acquisitions. We are proud of our high-quality, diverse product portfolio, channel footprint and global operating scale. Our products are sold into the homecare, long-term care, retail, and e-commerce channels in more than 100 countries around the world.

“Leading the World with Innovative Solutions that Enhance Lives”

Summary (Major Purpose of the Role): Validation and verification activities for design & development and regulatory product launch of respiratory medical products

Main Activities/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. This will include 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. Where appropriate, this will include 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.
Strong written, persuasion, consensus building, listening, and verbal communication skills.
Analyzing product and sub-system requirements.
Analyzing and verifying medical device designs.
Details written procedures that test for success, failure, and integration/performance testing.
Conducting statistical analysis of test results.
Maintaining and controlling test execution records using good lab practices.
Provides support for establishing Risk Management File and Usability Engineering requirements.

Competencies:

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

Reporting Relationships and Supervision:

This position works under the supervision of the Product Assurance Manager and may receive guidance from the Product Assurance Engineer. Areas of responsibility are reviewed frequently.

Education and Experience:

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.

Why Apply to Drive Medical…

Competitive Benefits, Paid Time Off, 401(k) Savings Plan

Drive Medical is an Equal Opportunity Employer and provides equal employment opportunities to all employees and applicants for employment. Drive Medical strictly prohibits and does not tolerate discrimination against employees, applicants, or any other covered person because of race, color, religion, gender, sexual orientation, gender identity, pregnancy and/or parental status, national origin, age, disability status, protected veteran status, genetic information (including family medical history), or any other characteristic protected by federal, state, or local law. Drive Medical complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities.