Description

Our client is seeking a Senior Project Manager to lead and manage complex project initiatives in the medical device sector. This role requires a strategic thinker who can coordinate new product development while ensuring alignment across multiple departments and stakeholders. You will be responsible for overseeing project timelines, budgets, and resources to deliver high-quality products that meet customer specifications and regulatory standards.

Duties and Responsibilities

• Lead and coordinate cross-functional teams to drive product development projects from concept through commercialization.
• Develop comprehensive project plans, including timelines, budgets, resource allocation, and risk management strategies.
• Act as the primary point of contact for internal and external stakeholders, providing regular project updates and managing expectations.
• Ensure compliance with regulatory requirements and quality system processes.
• Facilitate effective communication and collaboration among team members and stakeholders to enhance project performance.
• Identify and mitigate project risks to minimize impact on timelines and deliverables.
• Conduct project reviews and implement lessons learned to drive continuous improvement.
• Support business development efforts by providing insights and assessments of project feasibility and potential impacts on timelines and profitability.
• Mentor and guide junior project managers in project management best practices.

Requirements

Qualifications

• Bachelor's degree in Engineering, Business Administration, or a related field; a Master's degree is preferred.
• A minimum of 7 years of experience in project management, particularly in the medical device or highly regulated environment.
• Proven experience managing complex projects with successful outcomes.
• PMP certification is highly preferred.
• Strong leadership skills and the ability to influence without authority.
• Exceptional communication and interpersonal skills.
• Ability to manage multiple projects simultaneously while maintaining attention to detail.
• Familiarity with FDA regulations and experience in the 510(k) process is a plus.
• Strong analytical and problem-solving skills with a focus on results.