Senior Medical Device Sustaining Projects Lead

Advantage Technical; Carlsbad (CA); On-site; USD 95,000 - 96,000; Full time

Job summary

Advantage Technical in Carlsbad, CA seeks a Senior Project Manager to lead sustaining engineering for an electromechanical medical device platform, spanning post-launch life cycle, design changes, manufacturing transfers, and end-of-life activities.

You will coordinate with R&D, Quality, Regulatory, Manufacturing, Operations, and Supply Chain across sites to scope, resource, and execute programs while upholding design controls and regulatory requirements.

Qualifications

• Bachelor's degree in Engineering or related technical discipline.
• Minimum 6 years of project management, engineering project leadership, or similar experience.
• Demonstrated success leading cross-functional medical-device projects.
• Experience working within the medical-device design-control process.
• Experience supporting products from commercial launch through sustaining engineering and product end-of-life.
• Experience managing projects involving hardware/software systems and disposable medical-device components.
• Strong understanding of regulated product-development and sustaining-engineering environments.
• Demonstrated ability to manage: project scope, schedules and milestones, risks and issues, resources, and executive-level communications.
• Excellent written and verbal communication skills.
• Ability to clearly and concisely communicate project status, risks, recommendations, and decisions to senior leadership.

Responsibilities

• Lead sustaining engineering projects that support product continuity, reliability, compliance, and lifecycle objectives.
• Manage projects ranging from focused corrective or improvement activities to larger design-change, manufacturing-transfer, and process-improvement initiatives.
• Develop and maintain detailed project schedules, milestones, resource plans, and execution plans.
• Coordinate activities across Engineering, Quality, Regulatory, Manufacturing, Operations, Supply Chain, and other functional teams.
• Track project execution against schedule, budget, resource, and technical objectives.
• Facilitate cross-functional decision-making by organizing technical information, evaluating alternatives, identifying trade-offs, and driving clear recommendations.
• Prepare and communicate project status reports, dashboards, milestone updates, risks, decisions, and action items.
• Lead regular project and stakeholder meetings to ensure alignment and accountability.
• Identify technical risks, resource constraints, knowledge gaps, and project dependencies and drive appropriate mitigation plans.
• Escalate significant risks, decisions, or schedule concerns to project and business leadership.
• Coordinate evaluation, development, testing, and implementation of technical solutions.
• Support design-control activities associated with post-market product changes.
• Partner with Regulatory Affairs to coordinate submission timing and ensure project schedules align with regulatory requirements.
• Support prioritization of R&D, manufacturing, process-improvement, and business-continuity initiatives.
• Manage projects involving globally distributed teams and manufacturing locations.
• Ensure project activities comply with applicable medical-device quality-system and regulatory requirements.

Skills

Cross-functional leadership

Executive-level communications

Technical problem-solving

Influence without authority

Project management

Communication

Education

Bachelor's degree in Engineering or related discipline

MBA

Tools

Microsoft Project

Microsoft Office

Project timeline tools

Job description

Advantage Technical in Carlsbad, CA seeks a Senior Project Manager to lead sustaining engineering for an electromechanical medical device platform, spanning post-launch life cycle, design changes, manufacturing transfers, and end-of-life activities.

You will coordinate with R&D, Quality, Regulatory, Manufacturing, Operations, and Supply Chain across sites to scope, resource, and execute programs while upholding design controls and regulatory requirements.