Job ID: JOB_ID_6532
Job Title: Technical Project Manager – Software as a Medical Device (SaMD)
We are seeking an experienced and highly skilled Technical Project Manager to lead the development and implementation of Software as a Medical Device (SaMD). This role is responsible for driving technical execution, ensuring compliance with quality, cybersecurity, and regulatory standards, and delivering projects on time and within budget. You will work closely with cross-functional teams and stakeholders to ensure successful product development from concept through launch.
Key Responsibilities:
- Project Planning & Execution: Develop and manage detailed project plans, timelines, dependencies, and budgets. Ensure alignment with committed delivery timelines and program goals. Collaborate with stakeholders to co-create comprehensive and accountable project plans. Integrate technical project plans with overall program plans in coordination with Program Managers. Lead technical execution and ensure development teams meet deliverables.
- Risk & Issue Management: Identify, assess, and mitigate project risks and issues proactively. Perform root cause analysis and implement effective solutions. Act as a problem solver to remove blockers and drive progress.
- Quality & Compliance: Ensure all deliverables meet quality standards and regulatory requirements. Maintain proper documentation, archiving, and knowledge sharing. Support adherence to medical device regulations and cybersecurity standards.
- Stakeholder Management: Identify, analyze, and prioritize stakeholder needs and expectations. Develop and execute stakeholder communication strategies. Provide regular updates on project status, risks, and progress. Manage expectations and ensure stakeholder satisfaction.
Required Qualifications:
- Bachelors degree in Computer Science, Engineering, or related field.
- 8+ years of overall experience.
- Minimum 4+ years in Technical Project Management.
- Strong understanding of Software Development Life Cycle (SDLC).
- Experience in regulated environments (Medical Device preferred).
- Proven experience managing cross-functional teams.
- Strong analytical, problem-solving, and organizational skills.
- Ability to work in fast-paced, dynamic environments.
- Excellent communication and stakeholder management skills.
Preferred Qualifications:
- Experience in Software as a Medical Device (SaMD).
- Knowledge of medical device regulations (FDA, ISO, etc.).
- PMP or equivalent project management certification.
- Experience with Agile/Scrum methodologies.
- Background in product development lifecycle (concept to launch).
- Experience in sustaining engineering and multi-site project execution.
- Familiarity with cybersecurity and compliance standards.
Work Environment:
- Flexible workplace model with a hybrid setup (onsite presence required based on policy).
- Collaborative, cross-functional team environment.
Special Requirements
Visa constraints: None specified. Screening steps: Not specified. Interview modes: Not specified. Domain restrictions: Medical Device (SaMD) preferred.
Compensation & Location
Salary: $70 – $90 per year (Estimated)
Location: Raleigh, NC
Recruiter / Company – Contact Information
Email: it@shefsolutionsinc.com
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