Technical Project Manager - Irvine, CA (Hybrid)

$120,000 - $150,000/Yr

Canon Recruiting Group - Irvine, CA

Full-time - Mid Level

Irvine, CA

Administrative and Support Services

About the position

The Technical Project Manager will play a crucial role in planning, driving, and managing resources and schedules for medical device projects. This position offers the opportunity to transition into a Technical Program Manager role within 6-12 months, focusing on project management within the medical device development lifecycle.

Responsibilities

• Develop and maintain a detailed Project Plan in alignment with the product development life cycle.
• Drive overall project schedule and address schedule conflicts with cross-functional teams.
• Direct and manage the performance of a cross-functional core team consisting of key technical/engineering leadership.
• Communicate frequently with Senior Operations Manager and CTO, providing regular updates on project progress and risks.
• Develop a strong understanding of product technology and interdependencies to drive project activities.
• Work across engineering teams to manage technical effort and design integration.
• Proactively manage project risks and develop plans to reduce them.
• Enable compliance with design control requirements such as ISO 13485 and FDA 21 CFR 820.
• Assist in resource planning and identify gaps between available and planned resources.
• Track project costs and ensure projects are managed within budget.

Requirements

• BS degree in Engineering or related field required; MS preferred.
• Minimum 3 years of medical device product development experience.
• Experience developing products that include hardware and software systems.
• Experience working with quality systems and understanding design history files.
• Experience with regulatory submissions (e.g., FDA 510(k)).
• Knowledge of medical device standards (e.g., ISO 13485).
• Excellent written, communication, and presentation skills.
• Proficient with MS Project, Smartsheet, or similar software.
• Proficient with Microsoft Office tools: Word, Excel, PowerPoint.

Nice-to-haves

• Experience in technical project management within the medical device industry.
• Ability to foster and maintain effective relationships with team members.
• Competencies: Customer focused, team player, persistence/resilience, pro-active with sense of urgency.

Benefits

• 401(k)
• Health care benefits