Location: Main office in San Diego, CA. Remote candidates will be considered.

Mainstay Medical

Mainstay Medical is a medical device company focused on marketing an innovative implantable neurostimulation system, ReActiv8®, for people with disabling chronic mechanical Low Back Pain. The company is headquartered in Dublin, Ireland, with subsidiaries operating in the United States, Australia, the United Kingdom, and Germany.

The Role:

The primary responsibilities of the Product Support Lead are to provide day-to-day leadership of the Product Support Department and to serve as its senior subject matter expert and as an ambassador for the ReActiv8 therapy. The Lead provides expert technical, clinical, and product support to field-based teams, physicians, medical staff, and, where escalated, patients. The Lead also oversees complaint intake by the department and leads the processes, tools, and metrics that make support consistent across all markets. The Lead guides, coaches, and sets the standard for Product Support Specialists and Associates, serving as the first point of escalation for the team, while the Director, Global Product Management retains formal people-management authority. This role reports to the Director, Global Product Management and works closely with Clinical Development, Patient Access, Quality, Regulatory Affairs, and Product Development.

Position Responsibilities:

Expert Technical and Clinical Support

Provide expert-level technical and troubleshooting support for implants, programming, software, and hardware to field personnel, physicians, and medical staff by phone, email, and remote tools.
Answer the internal urgent support line and support live cases, reprogramming, troubleshooting, and follow-ups, including on-call support as needed in the evenings and on weekends.
Support clinical questions from MRI clinics, advanced practice providers, and hospital staff using approved labeling and resources.
Handle escalated patient questions from Patient Management and the main line with empathy, then direct patients back to their Patient Manager or field representative.
Respond to physician requests for off-label information in accordance with Mainstay SOPs. Provide non-promotional, scientifically sound data to support physician decision-making, separate from Sales influence.
Provide field support coverage as needed, including presence in the OR or clinic.
Serve as the first point of escalation for Product Support Specialists and Associates across the US and international regions, providing day-to-day technical direction on live cases and open issues.
Coordinate team scheduling and coverage, including after-hours and leave coverage, and escalate staffing gaps to the Director.

Complaint Intake, Quality, and Compliance

Ensure complaints received by the department are documented and entered into Grand Avenue Software (GAS) accurately and on time, and that possible adverse events are escalated to Quality immediately.
Review complex complaint intakes before they are handed off to Quality.
Track common issues and questions that do not qualify as complaints, and provide trend data upstream for product improvement.
Maintain Product Support SOPs and work instructions, recommend updates, and support inspection readiness.

Training, Knowledge, and Continuous Improvement

Develop and implement training for Product Support team members, and coach and mentor them to build technical and clinical expertise.
Lead onboarding for new Product Support team members, participate in interviewing candidates for the department, and give the Director hiring and development input.
Use the support technology stack (RingCentral, ticketing and knowledge base platforms, Microsoft Teams) in daily operations and train team members on it. Provide user input on tool configuration and validation.
Collect and track weekly operational, monthly tactical, and quarterly strategic KPIs, including the data behind the hiring gateway metrics, and report them to the Director.
Own the knowledge base and FAQ content governance and author technical content. Ensure external content is approved through Medical, Legal, and Regulatory (MLR) review.
Provide technical content for website troubleshooting and education resources owned by Marketing.
Lead post-contact surveys and customer success initiatives.
Evaluate ReActiv8 support needs and share product improvement input with the Global Product Manager and Product Development.
Lead support readiness for new product generations.
Manage multiple priorities and deadlines successfully and handle stressful situations accordingly.
Comply with the policies, procedures, and work instructions of Mainstay Medical.
Take on additional responsibilities as required.

Qualifications:

Bachelor's Degree required (nursing, engineering, life sciences, or a related field preferred).
Minimum 5 years of experience in a medical device organization, with expert knowledge of active implantable or neuromodulation systems.
Experience working in a hospital environment with an emphasis on OR/ICU experience required.
Possesses a strong working knowledge of interventional pain procedures and can verbalize techniques to support troubleshooting efforts at sites utilizing Mainstay systems.
Experience in direct patient interaction, patient education, or patient support required.
Experience leading, mentoring, or training others required; formal people management experience preferred.
Working knowledge of medical device complaint handling and adverse event reporting (ISO 13485; FDA 21 CFR 803; EU MDR vigilance) preferred.
Experience with call center, product support, or ticketing and telephony systems preferred.
Proficient in computer operations, including Microsoft Office Suite, and basic database management.
Possesses excellent coaching/teaching skills along with written and oral communication skills in English.

The salary range for this position is $120,000 to $135,000/year; however, base pay offered will take into account a range of factors, including job-related knowledge, skills, and experience. The total compensation package includes a range of medical, dental, vision, financial, and other benefits, as well as equity.

Mainstay Medical is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to gender, race, color, religious creed, national origin, age, sexual orientation, gender identity, physical or mental disability, and/or protected veteran status. Mainstay Medical participates in E-Verify.

MML US Inc

Product Support Lead

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