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Engineering Project Manager
151528
Posted:
10th March 2024
- 130000 USD - 160000 USD
- San Jose, United States
- Permanent
Position Overview:
You will lead cross-functional teams—including R&D, marketing, quality, and operations—to ensure the successful execution of product development programs. You will work closely with our engineering and regulatory teams to ensure compliance with FDA regulations and internal quality systems. This role requires a strong understanding of the medical device industry, product lifecycle management, and the ability to manage complex projects from inception to completion.
What you will do:
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Lead cross-functional teams to ensure the timely and successful launch of new products or updates to existing ones.
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Define and manage project scope, budget, and schedule.
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Collaborate with engineering, marketing, and quality teams to address issues as they arise, guiding the team toward timely decisions that consider business, quality, and compliance trade-offs.
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Identify critical paths, constraints, contingencies, and risks to achieve project objectives.
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Communicate project status and escalate risks to stakeholders.
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Ensure compliance with design controls and quality system procedures.
Key Responsibilities:
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Manage multiple product development projects, ensuring they are completed on time and within scope.
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Facilitate communication across teams to ensure alignment on project goals and progress.
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Monitor project risks and implement strategies to overcome challenges.
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Ensure strict adherence to FDA regulations and quality standards.
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Prepare and deliver reports to senior leadership on project milestones, risks, and outcomes.
What you need:
Required:
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Bachelor’s degree in engineering or a related field.
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Familiarity with FDA regulations and Quality Management Systems.
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5+ years of project management experience in medical device product development.
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2+ years of engineering experience in a product development environment.
Preferred:
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Startup experience
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PMP certification or equivalent