Program Manager - Medical Device, Class II Experience Needed
We are seeking a highly skilled Program Manager to lead and oversee cross-functional projects within the medical device industry. This role requires strong leadership, project management expertise, and the ability to collaborate with internal teams and external partners to drive successful project execution.
Key Responsibilities:
- Plan and directly manage cross-functional projects, including collaboration with external resources and contracted companies.
- Develop comprehensive project plans, secure necessary approvals from senior management and stakeholders, and ensure alignment with business goals.
- Proactively identify and assess risks, escalate issues in a timely manner, and propose strategic solutions to mitigate potential challenges.
- Partner with development team members to drive accountability and ensure high-quality execution of project tasks and deliverables.
- Continuously prioritize team activities and follow up on action items to ensure project progress.
- Oversee and manage program budgets, generate accurate forecasts, and track actual expenditures against projected costs.
- Monitor project progress against the plan and implement necessary corrective actions or contingencies to maintain commitments.
- Provide regular project status updates to management, highlighting variances from the plan and recommending appropriate corrective actions.
- Work closely with functional management to secure resource commitments and resolve project-related issues efficiently.
- Provide input to directors, managers, and senior leadership regarding team member performance and contribute to performance evaluations.
- Effectively manage performance issues and conflicts, fostering a productive work environment.
- Ensure compliance with design control and product development processes, facilitating adherence to regulatory requirements.
- Maintain clear and effective communication across project teams, ensuring that all activities and decisions are properly documented.
Education:
- Master's degree (MS) in an Engineering discipline or higher.
- Advanced skills in project management, project reporting, and presentations.
- Excellent written and verbal communication skills.
Experience:
- 8+ years of project management experience handling complex laser-based systems.
- 10+ years of technology development experience in one or more of the following areas: laser systems, electro-opto-mechanical systems, optics-based medical devices.
- Proven track record of successfully executing complex, multi-functional projects on time and within budget.
- Ability to manage multiple projects in a fast-paced product development environment.
- Demonstrated experience working within a controlled product development process.
- Familiarity with Design Controls and Risk Management practices, regulations, and industry standards is preferred, including:
- FDA QSRs
- ISO 13485
- EU MDR
- ISO 14971
- IEC 60601, 60825, and 62366
This role presents an exciting opportunity for a highly motivated Program Manager with expertise in laser-based medical devices and strong project management capabilities.