About The Position

This role does not have direct people management responsibility and requires active technical engagement alongside program leadership. Collaborate with New Product Development teams on equipment, automation, and line development initiatives. Develop and manage integrated program plans, timelines, budgets, and resource strategies for multiple concurrent initiatives. Establish milestones, monitor adherence to master schedules, and proactively resolve issues impacting scope, cost, or timeline. Apply structured risk management practices to identify, assess, and mitigate technical and business risks. Guide equipment selection, line design, automation strategy, and process controls to ensure robust, efficient, and compliant solutions. Ensure clear, timely, and transparent communication with site leadership and key stakeholders. Prepare and deliver program and technical updates to senior leadership as required. Provide strong technical and program leadership across Engineering, Process Development, Operations, Quality, and Supply Chain. Build and maintain strong cross-functional relationships to ensure alignment, technical rigor, and program success. Act as a technical decision partner, influencing equipment and process trade-offs across multiple programs. Delegate work based on technical complexity and program risk, ensuring accountability and timely execution. Resolve conflicts, remove barriers, and escalate issues as needed to maintain momentum. Influence key technical and program decisions while ensuring alignment with business, quality, and operational objectives.

Requirements

  • Bachelor's degree with 7+ years of experience, or Master's degree with 5+ years of experience
  • Demonstrated engineering experience supporting equipment development, automation, or manufacturing process development (not solely project coordination)
  • Proven experience leading complex technical programs or projects in engineering or technology development environments
  • Strong technical judgment with the ability to engage in detailed engineering discussions and risk assessments
  • Demonstrated excellence in project planning, execution, and data-driven decision-making
  • Experience managing budgets, schedules, resources, and risk across multiple initiatives
  • Strong leadership, collaboration, and influencing skills across functions and sites
  • Excellent communication and presentation skills
  • Ability to manage multiple priorities and deliver results in a fast-paced environment
  • Demonstrates a primary commitment to patient safety and product quality through compliance with the Quality Policy and Quality System requirements
  • Ensures appropriate resources are available to maintain Quality System compliance
  • Establishes and promotes a work environment that supports quality, compliance, and continuous improvement

Nice To Haves

  • PMP or equivalent project/program management certification
  • Technical background in machine design, automation, or process development, ideally within a regulated industry
  • Experience supporting manufacturing scale-up, equipment qualification, or technology transfer

Responsibilities

  • Collaborate with New Product Development teams on equipment, automation, and line development initiatives.
  • Develop and manage integrated program plans, timelines, budgets, and resource strategies for multiple concurrent initiatives.
  • Establish milestones, monitor adherence to master schedules, and proactively resolve issues impacting scope, cost, or timeline.
  • Apply structured risk management practices to identify, assess, and mitigate technical and business risks.
  • Guide equipment selection, line design, automation strategy, and process controls to ensure robust, efficient, and compliant solutions.
  • Ensure clear, timely, and transparent communication with site leadership and key stakeholders.
  • Prepare and deliver program and technical updates to senior leadership as required.
  • Provide strong technical and program leadership across Engineering, Process Development, Operations, Quality, and Supply Chain.
  • Build and maintain strong cross-functional relationships to ensure alignment, technical rigor, and program success.
  • Act as a technical decision partner, influencing equipment and process trade-offs across multiple programs.
  • Delegate work based on technical complexity and program risk, ensuring accountability and timely execution.
  • Resolve conflicts, remove barriers, and escalate issues as needed to maintain momentum.
  • Influence key technical and program decisions while ensuring alignment with business, quality, and operational objectives.
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