Senior Engineer, Medical Device Product Field Service Process Documentation Specialist

Job Title: Senior Engineer, Medical Device Product Field Service Process Documentation Specialist r

Location: Center City, Philadelphia (On-site 5 days per week)

Start: Immediate

Overview:

Our client a dynamic and innovative biomedical startup dedicated to developing cutting-edge medical devices is seeking a skilled and motivated Senior Engineer, Medical Device Product Field Service Process Documentation with experience in medical devices to join our growing team. As a key member of their team, you will be responsible for the crafting the writing of the Field Service Organizational Procedural Plan (FSO-SOP) which will include diagnosis, maintenance, troubleshooting, and repair of capital medical devices under development.

Responsibilities:

• Documentation & Reporting: Complete detailed service reports, including problem descriptions, actions taken, and follow-up recommendations. Maintain accurate records of service activities and compliance with safety standards. Ability to support the drafting of servicing procedures and forms for accurate documentation of work.
• Troubleshooting & Diagnostics: Diagnose, troubleshoot, and resolve technical issues with medical devices in house and at a local clinical site to ensure minimal downtime and optimal functionality.
• Customer Interaction: Build and maintain strong relationships with coworkers, healthcare professionals and hospital staff, offering excellent customer service while ensuring satisfaction with our products.
• Compliance & Quality Assurance: Ensure compliance with regulatory requirements, safety standards, and company policies. Support quality control processes and help ensure devices meet all industry standards.
• Collaboration: Work closely with engineering, product development, and customer support teams to provide feedback on device performance and areas for improvement.

Qualifications:

• Experience: Minimum of 8-10 years of experience as a Service Engineer or similar role working with medical devices, preferably in critical care devices including electromechanical systems, medical gas systems, and thermoregulation.
• Documentation: Develop a robust set of system diagnostic and service procedures including tracking and reports ready for utilization and submission to regulatory bodies.
• Technical Expertise: Strong troubleshooting, repair, and maintenance skills for electronic and mechanical medical devices. Provide technical support for compliant investigation. Experience with biomedical instrumentation equipment is highly preferred. Use of standard safety test equipment is required.
• Degree or certification in Mechanical, Biomedical, or Electrical Engineering, or a related technical field.
• Proficiency in reading and interpreting technical drawings, reports, and schematics.
• Ability to support development and refinement of service manual and quality records.

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System One, and its subsidiaries including Joulé, ALTA IT Services, TeamPeople, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

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