Solution Implementation Lead (Connected Devices)
$88,600–$246,600 year
RemoteUnited States
Job Summary
Own end-to-end execution of new connected medical device and digital health solutions from business case approval through Business Go-Live, serving as the single point of accountability for startup outcomes. Partner with Strategic Solutions Leads to evaluate solution feasibility, operational workflows, regulatory considerations, and validation approaches, while developing business cases and supporting go-to-market strategy. Lead cross-functional orchestration across Engineering, IT, Validation, QA, Regulatory, and Operations to translate concepts into technical requirements, manage vendor relationships, and resolve complex issues. Ensure solution-level readiness by completing documentation, validation, training, and compliance requirements, then transfer ownership to study execution leadership post-handoff. This role focuses on the respiratory service line and requires direct experience supporting respiratory clinical trials.
Required Qualifications
- Key Responsibilities and Oversight Experience supporting respiratory clinical trials (e.g., asthma, COPD, pulmonary indications) is required.
- Candidates without direct respiratory trial experience clearly demonstrated within their resume will not be considered.
- Strong knowledge of digital health, connected medical devices, and regulated clinical environments is required and must be clearly outlined in your resume/CV.
- Working knowledge of FDA guidelines and global regulatory expectations and their operational impact.
- Advanced project and program management skills in complex, matrixed organizations.
- Excellent technical aptitude related to systems, platforms, integrations, and device workflows.
- Strong communication, stakeholder management, and executive-level presentation skills.
- Proven ability to establish and maintain effective working relationships with internal teams, vendors, sponsors, sites, and clients.
- Occasional travel may be required.
- Bachelor's degree or equivalent combination of education, training, and experience.
- 10+ years of relevant experience in healthcare, pharmaceutical, life sciences, or digital health environments.
- Demonstrated leadership experience managing people, operations, and cross-functional initiatives.
- Strong business acumen with experience supporting solution development, commercialization, and delivery.
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