Project Manager

Sunrise Systems, Inc.; Miami (FL); On-site; USD 120,000 - 165,000; Full time

Job summary

Sunrise Systems, Inc. is seeking an experienced leader to plan and oversee multi-site technology transfer programs for medical devices. You will drive project governance, budgets, and risk management while coordinating stakeholders across manufacturing, engineering, and quality teams.

The role requires 10+ years in operations or PMO with ISO 13485 exposure and a proven track record in design changes and regulatory compliance. Travel 10–15% is expected.

Qualifications

• Bachelor's degree in Engineering or related field with 10+ years in operations environment (manufacturing/engineering/PMO)
• 5-10 years leading medium to large tech transfer projects with ISO 13485/global compliance
• Experience leading design changes and tech transfer in Medical Device/Diagnostics regulatory space
• Strong leadership and communication skills to influence at all levels
• Lean Six Sigma or DBS manufacturing techniques and team-based work experience
• Urgency and results-driven
• Willingness to travel 10-15%

Responsibilities

• Plan and design technology transfer projects, establishing success criteria and governance
• Maintain program budgets, cash flow analyses and cost estimates
• Provide executive visibility through progress reports and stakeholder communications
• Identify and manage program risks and controls using standard methodologies
• Coordinate cross-functional teams and deliverables across sites and functions
• Drive improvements in design change and supplier qualification with Quality/Regulatory/Operations
• Lead multiple PMs and enable aggressive but compliant project execution

Skills

Leadership

Communication

Problem-solving

Team-based work

Sense of urgency

Education

Bachelor's degree in Engineering

Master's degree

Tools

Power BI

Smartsheet

Miro

Excel

PM software

Job description

• Take full accountability and control of the delivery of multi-disciplinary, multi-site technology transfer projects/programs that deliver critical and strategic business benefits.
• Plan and design technology transfer projects/programs, identifying success criteria, setting controls and ensuring appropriate program infrastructure, governance and change management processes are in place while proactively monitoring and reporting on progress through an established governance framework.
• Ensure executive visibility of technology transfer programs/projects and manage communication across stakeholders, soliciting support and cross-team resolution of challenges when they arise.
• Establish and maintain technology transfer program / project budgets, cash flow analyses, and cost estimates related to the program.
• Establish and utilize effective risk management and mitigation practices through proper risk identification, assessment, tracking and communication.
• Coordinate and align multiple project and stakeholder groups, and develop and deliver progress reports, proposals, requirements documentation and presentations to various audiences, including project teams, sponsors, steering team and executive level key stakeholders.
• Bring together vision, strategy and implementation to deliver programs to business objectives.
• Collaborate, challenge and define innovative, compliant opportunities to increase the efficiencies and effectiveness of design change and supplier qualification processes partnering constructively with Quality, Regulatory and Operations stakeholders.

The essential requirements of the job include:

• Bachelor's degree required with a preference in an Engineering related field with 10+ years of related experience in an operations environment (manufacturing, engineering, operations PMO). Or master's degree with 8+ years' experience.
• 5-10 years of experience in leading all aspects of medium to large scale technology transfer projects/programs requiring compliance with ISO 13485 and Global compliance requirements.
• Proven experience leading all aspects of medium/large design changes, and all aspects of technology transfer programs/projects in the Medical Device or Diagnostics regulatory environment
• Excellent leadership, communication, and interpersonal skills, with the ability to influence and build relationships at all organizational levels.
• Fully competent problem-solving methods and demonstrated track record of utilizing DBS manufacturing techniques / other lean six sigma tools, and leading in a Team based work environment.
• Results focused with a proven track record of improvements and efficiencies.
• Sense of urgency.

Travel, Motor Vehicle Record & Physical/Environment Requirements:

Ability to travel – 10-15%

It would be a plus if you also possess previous experience in:

• Prior experience leading multiple PMs.
• Change Management Certification desired (Prosci/ADKAR or Other)
• Proficiency in Power BI/Smartsheet, Miro, Excel and PM software.