Program Manager, Sustaining

We are seeking an experienced and dynamic Program Manager, Sustaining with a strong background in sustaining and remediation within the medical device industry. In this pivotal role, you will lead sustaining projects, remediation initiatives, and other business-critical efforts from conception through to market commercialization. You will play a crucial role in managing complex projects, building networks with key contacts, and resolving intricate issues creatively and effectively.

Knowledge:

• Sustaining Engineering: In-depth understanding of sustaining engineering processes, ensuring the ongoing support and optimization of existing products.
• Regulatory Standards: Familiarity with ISO and FDA quality systems regulations, including post-market surveillance and remediation activities.
• Phase/Gate Process: Knowledge of phase/gate approach to NPI and design control procedures.

Skills:

• Leadership: Ability to lead high-performing teams, manage cross-functional project activities, and drive remediation efforts effectively.
• Project Management: Expertise in project management, including planning, scheduling, tracking, and risk management.
• Communication: Excellent written and verbal communication skills, capable of adapting style to different audiences and facilitating group discussions.
• Technical Proficiency: Advanced knowledge in product development, sustaining engineering, and strategic thinking.
• Analytical Skills: Strong technical aptitude with the ability to analyze data, manage complex issues, and implement remediation solutions.
• Tools Proficiency: Proficient with Microsoft Office, Microsoft Project, PPM tools (e.g., Smartsheet, Planview), and reporting dashboards.

Behaviors:

• Strategic Thinking: Demonstrates strategic thinking and contributes to the development and standardization of policies and procedures.
• Collaboration: Works effectively with cross-functional teams and promotes knowledge transfer and collaboration.
• Continuous Improvement: Champions opportunities for process enhancement and implements new tools, technologies, and methods.
• Proactive Work Ethic: Self-starter with a strong proactive work ethic, well-organized, and detail-oriented.
• Mentorship: Provides guidance, feedback, and support to team members and promotes a culture of continuous learning.

Experiences:

• Education:
  • Preferred Minimum Non-Technical Degree: College Degree
  • Preferred Minimum Technical/Advanced Degree: Master’s Degree
• Industry Experience:
  • 8+ years with a non-technical degree.
  • 6+ years with a Master’s Degree.
  • 3+ years with a PhD.
• Project Leadership:
  • Experience leading large cross-functional projects with global reach.
  • Experience in sustaining engineering and remediation efforts for medical devices.
• Regulatory Experience:
  • Experienced with ISO and FDA quality systems regulations, including post-market activities.
  • Prior experience in medical device design, development cycles, and remediation projects.
• Professional Development:
  • Participates in professional development and stays current with industry best practices.
  • PMP Certification is beneficial.

Essential Duties and Responsibilities:

• Lead sustaining and remediation projects and other business-critical initiatives from charter to commercialization.
• Guide the program core team, ensuring flawless interfaces and interdependencies between functions.
• Establish program objectives, measurable goals, and program scorecards.
• Collaborate with Core Team to establish resources needed and budget to execute program commitments.
• Author the Product Development Plan and ensure other functional planning documents are completed and up to date.
• Develop integrated cross-functional schedules, identifying critical paths, risks, and dependencies.
• Identify and facilitate program and product risk identification throughout the program cycle, ensure effective mitigations in place; monitor risks throughout the program; transfers documentation.
• Utilize Design Control phase/gate processes to execute programs and facilitate phase gate exit readiness reviews.
• Coordinate core team meetings and p