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. This role is located in Newark, DE and we are open to hybrid within the tri-state area. 

Knowledge:

• Sustaining Engineering: In-depth understanding of sustaining engineering processes, design control methodologies, 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 to support on market products. 
• 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.
• Coordinate core team meetings and prepare program status reports.