Analysis Skills, Artificial Intelligence (AI), Atlassian JIRA, Best Practices, Budget Management, Budgeting, Candidate Screening, Change Management, Communication Skills, Continuous Improvement, Corrective Action, Cross-Functional, Design Services, Documentation, Engineering, Engineering Change Order, Engineering Management, Establish Priorities, FDA (Food and Drug Administration), FDA Requirements, GMP (Good Manufacturing Practices), Genetics, Hospital, ISO (International Organization for Standardization), Leadership, Maintain Compliance, Manufacturing, Manufacturing Management, Manufacturing Operations, Medical Equipment, Microsoft Project, Multitasking, Operational Support, Problem Solving Skills, Process Improvement, Production Schedule, Production Support, Project Execution, Project Lifecycle, Project Management Certification, Project Management Professional (PMP), Project Management Software, Project Planning, Project Tracking, Project/Program Management, Purchasing/Procurement, Quality Management, Quality System Requirements (QSR), Regulations, Regulatory Compliance, Resource Management, Risk Analysis, Risk Management, Status Reports, Supply Chain, Supply Chain Management, Team Player, Technical Leadership, Technical/Engineering Design, Time Management, Validation Plan, eCos
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 such as MS Project, Smartsheet, or Jira.
- Knowledge of engineering documentation processes, including ECO/ECR and validation protocols.
- Strong risk management capabilities, including risk identification, assessment, and mitigation planning.
- Demonstrated problem-solving skills with sound judgment in complex decision-making scenarios.
- Excellent communication skills, with the ability to clearly convey technical and project information to diverse stakeholders.
- Proven ability to influence stakeholders and drive alignment in cross-functional environments.
- Ability to manage competing priorities and multiple concurrent projects in a fast-paced, dynamic setting.
- Experience working within quality systems such as FDA, ISO, and GMP.
Additional Skills & Qualifications
- Bachelor's degree in Engineering, Manufacturing, Operations, or a related technical field.
- Advanced degree in a relevant discipline is preferred.
- Professional project management certification (such as PMP) is highly valued.
- Experience working specifically in Class III medical device manufacturing environments.
- Background in engineering management or manufacturing project leadership.
- Familiarity with structured project management methodologies and PMO frameworks.
- Strong analytical skills with the ability to translate technical requirements into practical project plans.
- Demonstrated ability to work effectively as a specialized individual contributor with high levels of ownership and accountability.
Work Environment
The role operates within a Class III medical device manufacturing environment that emphasizes regulatory compliance, quality, and continuous improvement. The position follows a hybrid work model, typically involving three days onsite and two days remote each week. Work hours align with a standard daytime schedule coordinated with manufacturing operations, supporting collaboration with production, engineering, and supply chain teams. The environment is highly collaborative and cross-functional, with frequent interaction among operations, product teams, purchasing, and PMO groups. Projects move quickly in a fast-paced, project-driven setting where priorities can shift based on business needs. The role requires regular participation in PMO meetings and structured status reporting cadences, and it involves working with modern project management tools and established quality system processes.
We reserve the right to pay above or below the posted wage based on factors unrelated to sex, race, or any other protected classification.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. This temporary role may be eligible for the following:
- Medical, Dental & Vision
- 401(k)/Roth
- Basic/Supplemental Life & AD&D
- Short and long-term disability
- HSA & DCFSA
- Transportation benefits
- Employee Assistance Program
- Company Paid Time off or State Sick Leave
Job Type & Location
This is a Contract position based out of Redmond, WA.
Pay and Benefits
The pay range for this position is $70.00 - $87.00/hr.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
- Medical, dental & vision
- Critical Illness, Accident, and Hospital
- 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available
- Life Insurance (Voluntary Life & AD&D for the employee and dependents)
- Short and long-term disability
- Health Spending Account (HSA)
- Transportation benefits
- Employee Assistance Program
- Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a hybrid position in Redmond,WA.
Application Deadline
This position is anticipated to close on Jul 3, 2026.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing winner for both client and talent service.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.
Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.