Engineering Project Manager

About the role

Pinnacle Method Consulting is seeking an experienced Engineering Project Manager to join our team. This position will work on a contract basis in the Bay Area and will be responsible for managing medical device projects.

Responsibilities

• Deep understanding of medical devices and product development, including FDA regulations and approval 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 on non-development tasks like Quality Management Systems (QMS), supply chain, and documentation.
• Interface with clients multiple times per week to plan and manage project efforts, ensuring client participation and outsourcing decisions.
• Work with Account Managers and Engineering Teams to assess project opportunities, estimate budgets, and timelines.
• Collect and analyze design and manufacturing data from clients to guide product development.
• Plan post-GAP Analysis design pathways and finalize product designs.
• Create detailed development plans, showing dependencies and schedule impacts, leading up to commercial production.
• Coordinate with technical leadership to finalize product features and develop manufacturing and FDA submission documentation.
• Coordinate regulatory consultations to ensure efficient design outputs and approvals.
• Supervise partners to maintain progress on design and resolve any communication issues between client and team.
• Search for specific contract manufacturing capabilities needed for successful product delivery and negotiate production agreements.
• Collaborate with clients and CM personnel to ensure production agreements are met and generate necessary documents for client understanding.
• Regularly report to Account Managers and Leadership Team on client satisfaction levels and the success of the product development team in both technical and communication aspects.

Requirements

• Deep understanding of medical devices and product development, including FDA regulations and approval processes.
• Understanding of engineering risk analysis and verification testing setups.
• Basic supply chain knowledge.
• A basic understanding of regulatory processes and quality set-ups is a plus.

Qualifications

• Experience in managing medical device projects.
• Strong understanding of engineering processes and med device development.
• Ability to lead and coordinate cross-functional teams.
• Excellent communication skills, both written and verbal.
• Proficiency in MS Project for project management.

Skills

• Medical device and product development expertise.
• Familiarity with FDA regulations and approval processes.
• Project management skills, including MS Project.
• Team leadership and coordination abilities.
• Communication skills, both written and verbal.
• Basic supply chain knowledge.

Benefits

• Competitive compensation package.
• Flexible working hours.
• Professional development opportunities.

Pay

Compensation is commensurate with experience.

Schedule

The position is on a contract basis.