This is a remote position.

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  Lead the planning and execution of medical device product development and commercialization projects from concept through launch.
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  Define project scope, objectives, deliverables, and success criteria in collaboration with cross-functional stakeholders.
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  Develop and maintain detailed project plans, timelines, resource allocations, and budgets.
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  Ensure alignment between project goals and organizational strategy through effective stakeholder management.
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  Serve as the primary liaison among R&D, Quality, Regulatory, Manufacturing, and Supply Chain teams to ensure seamless project execution.
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  Coordinate and track cross-functional deliverables, facilitating effective communication and issue resolution.
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  Lead project team meetings, design reviews, and phase-gate reviews, ensuring all actions and decisions are documented.
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  Drive accountability across teams to meet milestones and maintain compliance with design control and quality system requirements.
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  Ensure all project activities align with Design Control (21 CFR 820.30), ISO 13485, ISO 14971, and other applicable standards.
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  Partner with Regulatory and Quality teams to support technical documentation, risk management, and DHF maintenance.
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  Manage change control processes and ensure that design and process changes are properly evaluated, documented, and approved.
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  Identify potential project risks and mitigation strategies, maintaining proactive issue resolution throughout the project lifecycle.
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  Monitor project budgets, costs, and resource utilization, providing regular updates to leadership.
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  Ensure timely escalation of risks, delays, or quality concerns that could impact project deliverables.
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  Support the development and implementation of best practices, templates, and processes to enhance project management effectiveness.
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  Contribute to continuous improvement initiatives related to project governance, documentation, and cross-functional collaboration.
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  Leverage project metrics and lessons learned to improve execution efficiency and product quality outcomes.

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  Bachelor’s degree in Engineering, Life Sciences, Project Management, Business, or a related field.
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  Proven experience managing projects in a regulated medical device, biotechnology, or pharmaceutical environment.
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  Strong understanding of product development processes, design control, and risk management (ISO 14971).
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  Proficiency with project management tools such as MS Project, Smartsheet, or equivalent.
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  Demonstrated ability to manage multiple complex projects simultaneously.
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  Excellent communication, documentation, and stakeholder management skills.
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  Strong problem-solving, analytical, and organizational abilities.

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  PMP, PRINCE2, or equivalent Project Management certification.
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  Experience with new product introduction (NPI), process validation (IQ/OQ/PQ), or post-market engineering projects.
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  Familiarity with MDSAP, EU MDR, and other international medical device frameworks.
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  Experience in Agile or hybrid project management environments.
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  Knowledge of resource planning, cost control, and vendor management in regulated product development.