Location: Newtown, PA and Currently Remote (could become onsite In Newtown, PA office)
Reports to: Director of Customer Support and Patient Services
This is a unique opportunity for an individual who is skilled in medical device system who enjoys helping users of a unique medical device to help their patients through support and troubleshooting through Tier 1 support issues and device inquiries. Superb customer relations skills, attention to detail, communications and excellent problem-solving skills are key success factors in this role.
Reporting to the Director of Customer Service and Patient Support, the Customer Service and Patient Support Technician helps system users overcome technical issues in real time to enable them to conduct uninterrupted patient care. Internally, s/he will work with cross-functional team members from Product Development, Quality, Medical, Commercial, and Operations. Delighting users in need of support is critical to success. Performing testing that makes a significant difference in the quality of the product is critical as well. Passion to work in a dynamic and fast-paced small-company environment are must haves for this individual.
Essential Duties and Responsibilities:
- Lead in the support of system users on calls and remote login sessions to answer questions, resolve problems and to enable the users to care for their patients in real time.
- Maintain an organized support agenda to follow-up with all callers ensuring completion and satisfaction
- Log all pertinent information clearly, succinctly, in entirety as required
- Track and trend metrics regarding this support function role to ensure continuous improvement
- Execute and maintain test plans and testing scripts to ensure that the software functions as expected and reliably according to documented requirements.
- Execute test plans and create test reports to describe application evaluation, testing and correction.
- Isolate, reproduce and document software defects and enhancements with follow up tracking and verification of fixes.
- Maintain effective communication with project teams on scope and requirement changes.
- Document outcomes, facilitate metrics gathering, test execution, and conduct defect management by utilizing software tracking tools.
- Bring a “can-do” attitude to work and deliver on other responsibilities as needed.
- Other duties as assigned.
Minimum Qualifications & Skills Required:
- Bachelor’s Degree in Computer Science, Data Science, Information System, Engineering, or related work experience
- Minimum two years relevant hands-on work experience in a regulated industry, preferably under medical devices ISO 13485 and IEC 62304
- Must have experience and/or understanding of implementation of software development processes in compliance with current U.S. and international regulations, including verification, validation, and issue management.
Professional Work Experience:
- Experience in medical device customer support
- Experience with software-based system testing and computer system validation
- Experience with system testing in the medical device industry
Other Essentials and Key Success Factors:
- Proven ability to perform under stress such as during customer complaint resolution
- Demonstrated commitment to problem resolution and solutions ensuring customer objectives are understood and met
- Experience in a small medical device company (start-up) environment preferred
- Demonstrated record of intellectual curiosity, innovation and creative problem solving with an entrepreneurial spirit
- Ability to lead fast-paced projects with a keen sense of urgency to get the job done well
- Working knowledge of ISO 13485 and IEC 62304 preferred
- Proven and successful track record as a team-player and collaborator in small team environments
- Highly organized and detail oriented with a passion to deliver quality results
- Excellent verbal and written communication skills, with experience translating technical concepts into user-friendly documentation
- Highest levels of professionalism, confidence, personal values, and ethical standards
Departmental procedures, HIPAA, general training on FDA current Good Manufacturing Practice (cGMP), ISO 13485, Canadian Medical Devices Regulations (CMDR), Medical Device Directive (MOD) and Medical Device Regulation (MDR).