Senior Project Manager

W2 Contract

Pay Rate: $60 - $70 per hour

Location: Santa Clara, CA - Onsite Role

Job Summary:

We are seeking a Project Manager or Senior Project Manager who is passionate about improving patient outcomes and thrives in a fast-paced, high-growth environment.

Duties and Responsibilities:

• Report to the Associate Director, PMO
• Manage timelines, scope, and deliverables for selected projects and programs.
• Collaborate with cross-functional teams, including Product Management, Engineering, Quality, Operations, Regulatory, and Marketing.
• Partner with Product Management to prioritize and execute initiatives aligned with company objectives
• Ensure all activities comply with applicable global regulatory and quality requirements outlined in our Quality Manual.
• Conduct business ethically and in compliance with the Code of Conduct, AdvaMed Code, and all applicable laws and regulations.
• Independently develop and manage project plans and timelines across multiple initiatives.
• Coordinate and lead cross-functional teams from project initiation through launch.
• Establish early-stage project plans, including business cases, scope, resources, and budgets.
• Identify, assess, and mitigate project risks; escalate issues when appropriate.
• Drive consensus among stakeholders and clearly communicate decisions and progress to leadership.
• Streamline project execution while maintaining compliance with Quality System requirements.
• Support Quality activities, including audits, CAPAs, design changes, and nonconformances as needed
• Support Operations programs and organizational initiatives as requested
• Develop and track metrics to ensure commitments related to scope, schedule, and resources are met.
• Proactively evaluate project timelines to identify risks, bottlenecks, and acceleration opportunities.
• Support the design and development of medical devices, instrumentation, and procedures.
• Assist with verification, validation, and product safety and performance evaluations.
• Exercise authority to halt product or documentation progression in cases of potential non-compliance and report issues to Quality, Regulatory, and management

Requirements and Qualifications:

• Bachelor's degree in Engineering or a related technical field
• Minimum of 5 years of project or program management experience
• Experience managing projects in a high-growth medical device organization
• Strong knowledge of medical device design controls and quality systems
• Working knowledge of cross-functional medical device operations, including R&D, manufacturing, clinical, regulatory, and quality
• Proficiency with Microsoft Project or similar project management tools
• Familiarity with applicable regulations and standards (e.g., FDA 21 CFR 820, ISO 13485, ISO 14971, EU MDR 2017/745)
• Experience in orthopedics preferred; spine experience a plus.
• Proven ability to manage complex engineering projects through development, launch, and post-market support

Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as a W2 candidate.

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