Engineering Project Manager

About the role

Pinnacle Method Consulting is seeking an experienced Engineering Project Manager to join our team. This position will work closely with clients in the Bay Area to manage medical device projects.

Responsibilities

• Deep understanding of medical devices and product development, including FDA regulations and processes.
• Understand engineering risk analysis and verification testing setups.
• Select Contract Manufacturers (CMs) locally or internationally for prototype and production builds.
• Lead medical product development teams in various subprojects or coordinate with another PM.
• Interface with clients multiple times per week to plan efforts and measure client participation.
• Work with Account Managers and Engineering Teams to assess opportunities and estimate budgets and timelines.
• Collaborate with technical leadership to finalize product features and develop detailed development plans.
• Coordinate regulatory consultations to ensure efficient design output acceptance.
• Supervise partners to maintain progress and resolve any communication issues.
• Generate and oversee the creation of various documents for product development and FDA submissions.
• Report regularly to the Account Manager and Leadership Team on client satisfaction and project success.

Requirements

• Deep understanding of medical devices and product development.
• Knowledge of FDA regulations and processes, including QMSR and ISO 13485.
• Basic supply chain knowledge.
• A basic understanding of regulatory process and quality set-ups is a plus.

Qualifications

• Experience managing medical device projects.
• Strong understanding of engineering and med device processes.
• Excellent communication skills, both written and verbal.
• Ability to manage multiple tasks and prioritize effectively.
• Experience with MS Project and conducting weekly status meetings.

Skills

• Project management skills.
• Understanding of medical device regulations and processes.
• Supply chain management.
• Team leadership and coordination.
• Effective communication and reporting.

Benefits

At Pinnacle Method Consulting, you'll have the opportunity to work on cutting-edge medical device projects, collaborate with industry leaders, and contribute to the success of innovative products.

Pay

Competitive compensation package based on experience and qualifications.

Schedule

Full-time position with flexible working hours to accommodate client needs.