Project Manager - Medical Device

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

Senior Project Manager – Medical Device Sustaining Engineering

Employment Type: Contract

Pay Rate: Up to approximately $69.50/hour

Work Authorization: Candidates must be authorized to work in the United States without current or future visa sponsorship.

Position Overview

A global medical technology organization is seeking an experienced Senior Project Manager to support sustaining engineering activities for a commercial electromechanical medical device platform consisting of reusable console equipment and disposable components.

This role will manage projects across the post-launch product lifecycle, including business continuity initiatives, process improvements, design changes, manufacturing transfers, product updates, and end-of-life activities.

The Project Manager will work closely with R&D, Manufacturing, Quality, Regulatory, Operations, Supply Chain, and other business functions across multiple sites to ensure projects are properly scoped, resourced, executed, and communicated.

The ideal candidate brings strong medical-device project management experience, a solid understanding of design controls, and the ability to lead technically complex cross-functional projects in a highly regulated environment.

Key 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.
• Scope
• Roles and responsibilities
• Workstreams
• Milestones
• Decision-making processes
• Communication plans
• 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.

Project Scope

Projects may include:

• Post-launch product support
• Design changes
• Manufacturing process improvements
• Design transfer
• Manufacturing transfer
• Product continuity initiatives
• Supplier or component changes
• Hardware modifications
• Software updates
• Regulatory submission support
• End-of-life planning

Required Qualifications

• Bachelor's degree in Engineering or a 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 both 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
• Executive-level communications
• Strong technical problem-solving and decision-making skills.
• Strong business judgment and ability to understand broader organizational priorities.
• Excellent written and verbal communication skills.
• Ability to clearly and concisely communicate project status, risks, recommendations, and decisions to senior leadership.
• Strong interpersonal skills and ability to influence without direct authority.

Preferred Qualifications

• PMP certification.
• MBA, master's degree, or other advanced degree.
• Previous experience as a:
• Project Manager
• Manufacturing Engineer
• Quality Engineer
• Experience managing projects involving electromechanical medical equipment, consoles, capital equipment, or reusable systems paired with disposable devices.
• Experience with sustaining engineering and post-commercialization product support.
• Experience with design changes and manufacturing transfers.
• Strong knowledge of medical-device design controls and product lifecycle processes.
• Comfortable presenting to executives, technical teams, business partners, and external stakeholders.
• Strong leadership, facilitation, relationship-building, and conflict-resolution skills.
• Experience leading geographically dispersed or global teams.
• Proficiency with Microsoft Project, Microsoft Office, and project timeline/reporting tools.

Ideal Candidate Profile

The successful candidate will be a technically capable project leader who can operate comfortably at the intersection of R&D, Quality, Manufacturing, Regulatory, and Operations.

They should be able to take ownership of complex projects, establish structure where needed, communicate effectively across multiple levels of the organization, and drive teams toward practical solutions while maintaining compliance with medical-device quality and regulatory requirements.