Engineering Project Manager

Job Title:

Senior Project Manager - Regulated Manufacturing / Class III Medical Devices

Job Description

This Senior Project Manager role leads complex engineering initiatives within a Class III medical device manufacturing environment. You will support production, engineering, and supply chain functions by driving the implementation of engineering and process changes that align with project goals. Working closely with operations and leadership teams, you will manage multiple concurrent projects, ensuring they are delivered on time, within budget, and in compliance with stringent quality and regulatory standards.

This is a specialized individual contributor position with significant ownership, influence, and visibility across the organization.

Responsibilities

+ Lead and manage multiple complex engineering and production projects within a regulated Class III medical device manufacturing environment.

+ Support production, engineering, and supply chain functions by planning and executing engineering and process changes that meet project objectives.

+ Develop, maintain, and oversee detailed project plans, including scope, timelines, budgets, resource allocation, and risk mitigation strategies.

+ Drive cross-functional alignment across operations, product teams, purchasing, and PMO groups to ensure clear project goals and execution strategies.

+ Coordinate technical resources and cross-functional teams to implement process and product changes with minimal disruption to production workflows.

+ Prioritize tasks and project activities based on business needs, resource constraints, and risk assessments, ensuring timely and effective delivery.

+ Authorize and manage project changes that impact scope, cost, schedules, or delivery timelines in accordance with established governance and quality systems.

+ Lead engineering change orders (ECOs), engineering change requests (ECRs), and related process improvement initiatives in manufacturing settings.

+ Ensure adherence to applicable quality systems and regulatory requirements, including FDA, ISO, and GMP standards, throughout the project lifecycle.

+ Plan, execute, monitor, control, and close projects using structured project management methodologies and best practices.

+ Identify, assess, and proactively manage project risks, issues, and dependencies, implementing corrective actions to maintain project stability.

+ Resolve operational challenges in collaboration with operations and manufacturing teams to maintain continuity of production and minimize downtime.

+ Translate technical requirements and engineering documentation into actionable project plans and clear deliverables for cross-functional teams.

+ Prepare and deliver regular project status updates, reports, and presentations to stakeholders and PMO groups, highlighting progress, risks, and mitigation plans.

+ Facilitate effective communication among engineering, production, supply chain, and PMO stakeholders to ensure alignment and timely decision-making.

+ Influence stakeholders at various levels to secure buy-in for project plans, process changes, and resource commitments.

+ Manage competing priorities in a fast-paced, dynamic environment while maintaining focus on quality, compliance, and continuous improvement.

+ Contribute to the refinement of project management processes, tools, and templates to enhance consistency and effectiveness across projects.

Essential Skills

+ Minimum 6+ years of experience in engineering project management within regulated manufacturing environments.

+ Proven experience managing engineering or production projects in regulated settings (e.g., FDA, ISO, GMP) with adherence to quality systems.

+ At least 6+ years of experience in full project lifecycle execution, including planning, executing, monitoring, and closing complex technical projects.

+ At least 5+ years of experience leading engineering change orders (ECOs), process improvements, and cross-functional implementations in manufacturing environments.

+ At least 5+ years of experience in cross-functional stakeholder management across engineering, production, supply chain, and PMO teams.

+ Strong proficiency in project management tools…