Process Engineer

Responsibilities

• 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.

Qualifications

• 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.

Required Skills

• 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%

Preferred Skills

• 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.