Design - Project Manager

Lancesoft; Miami (FL); On-site; USD 48,000 - 68,000; Full time

Job summary

Lancesoft is seeking a Design – Project Manager in Miami to lead global operations technology transfers from concept through initiation, planning, execution and transition to supply chain and manufacturing. You will ensure program governance and compliance with ISO 13485 and related regulations, delivering critical business benefits.

The role requires 10+ years in technology transfer or engineering within manufacturing, strong leadership, and proven ability to manage budgets, risk, and

Qualifications

• Bachelor’s in Engineering with 10+ years in manufacturing/operations PMO.
• 10+ years in technology transfer projects with ISO 13485 compliance.
• Experience leading large design changes and tech transfer in Medical Device/Diagnostics regulatory environments.
• Strong leadership, communication and stakeholder management.

Responsibilities

• Lead multi-site technology transfer projects delivering critical business benefits.
• Plan and design transfer programs with governance and change management.
• Maintain budgets, cash flow analyses and cost estimates for the program.
• Provide executive visibility through reports and presentations to stakeholders.

Skills

Project management

Leadership

Communication

Risk management

Problem solving

Regulatory awareness

Cross-functional collaboration

Education

Bachelor’s in Engineering or related field

Master’s degree (preferred)

Tools

Power BI

Smartsheet

Miro

Excel

PM software

Job description

0 - 12+ months contract with possible extension Pay: $42.25 per hour on W2.

The Design –Project Manager is responsible for the management and execution of Global Operations product and technology transfers, and strategic programs from concept through initiation, planning, execution and transition to supply chain and manufacturing operations. This will include ensuring that all requirements as a part of such programs are fully executed in a compliant fashion. In this role, you will have the opportunity to:

• 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.