Project Manager

Project Manager

This role oversees complex, cross-functional projects within a regulated medical device environment. The Project Manager leads initiatives spanning medical device development, regulatory compliance, remediation, and product lifecycle management, ensuring all activities align with applicable regulations and organizational objectives. The position requires strong project leadership, deep familiarity with FDA regulations, and the ability to coordinate diverse teams and stakeholders from project initiation through successful completion.

Responsibilities

• Lead and manage multiple concurrent projects that support medical device development, regulatory compliance, remediation activities, and product lifecycle initiatives.
• Develop and maintain detailed project plans, including schedules, milestones, risk registers, and resource allocation plans.
• Create and maintain executive-level dashboards for program reviews, status reporting, KPI tracking, and portfolio visibility.
• Coordinate cross-functional teams, including Regulatory Affairs, Quality, R&D, Clinical, Manufacturing, Supply Chain, and Marketing, to ensure alignment and timely delivery of project objectives.
• Ensure project deliverables comply with FDA regulations and internal standards, and that they meet established timelines and organizational goals.
• Facilitate project governance meetings and present clear updates on project status, risks, issues, and mitigation plans to stakeholders and leadership.
• Monitor project budgets, schedules, and resource utilization to ensure projects are delivered on time and within scope.
• Identify, assess, and manage project risks and dependencies, implementing corrective and preventive actions when necessary.
• Drive accountability across project teams by setting expectations, tracking progress, and ensuring timely completion of deliverables.
• Support inspection readiness activities and regulatory compliance efforts related to ongoing and planned projects.
• Contribute to continuous process improvement initiatives by identifying opportunities to enhance project management practices, tools, and workflows.

Essential Skills

• Bachelor's degree in Engineering, Life Sciences, Business, or a related field.
• At least 5 years of project management experience, preferably within the medical device, life sciences, or regulated healthcare industry.
• Strong working knowledge of FDA regulations and their impact on product development and compliance activities.
• Demonstrated experience in project scheduling, resource planning, workflow management, and project reporting.
• Proven ability to build and manage dashboards for executive and program review meetings.
• Experience leading cross-functional teams and managing complex projects with multiple stakeholders.
• Strong skills in risk management, project planning, organization, and communication.
• Proficiency with Microsoft Office Suite, including Excel, PowerPoint, and Teams.

Additional Skills & Qualifications

• Project Management Professional (PMP) certification preferred.
• Familiarity with Quality Management Systems (QMS), design controls, risk management processes, and regulatory submissions.
• Experience working in Agile, Waterfall, or hybrid project management environments.
• Background in engineering management or medical device project work is advantageous.

Work Environment

The role operates within a regulated medical device environment that emphasizes quality, compliance, and cross-functional collaboration. You will work closely with teams across Regulatory Affairs, Quality, R&D, Clinical, Manufacturing, Supply Chain, and Marketing, using standard productivity tools such as Microsoft Excel, PowerPoint, and Teams for communication, planning, and reporting. The position typically follows standard business hours, with flexibility as needed to support critical project milestones, governance meetings, and inspection readiness activities. The culture values accountability, transparency in project status and risk reporting, and continuous improvement in processes and tools, providing a professional setting focused on delivering safe and effective medical products.

Job Type & Location

This is a Contract position based out of Centennial, CO.

Pay and Benefits

The pay range for this position is $57.69 - $57.69/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 fully remote position.

Application Deadline

This position is anticipated to close on Aug 27, 2026.