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PROGRAM MANAGER (MED DEVICE)

PROGRAM MANAGER (MED DEVICE)

AptyxTempe, AZ, USA
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The Manufacturing Program Manager plays a critical role in leading medical injection molding and assembly programs from concept through to commercial launch. This role combines strategic oversight with hands-on leadership, ensuring that all manufacturing programs are delivered on time, within scope and budget, and in full compliance with regulatory, quality, and customer expectations.

The ideal candidate brings deep experience in regulated manufacturing environments, excels at cross-functional leadership, and is passionate about continuous improvement, technical excellence, and delivering innovative solutions to customers in the medical device space.

In addition to new program development, this role will also support the transition and ongoing oversight of current programs, including relocation of manufacturing programs between sites. This includes planning and executing knowledge transfer, tooling moves, and validation activities to ensure business continuity and customer satisfaction.

Key Responsibilities

Program Management & Execution

  • Manage the full lifecycle of manufacturing programs-from initial scoping and planning to execution, validation, and launch.
  • Oversee site-to-site program transfers, ensuring smooth relocation of tooling, equipment, processes, and documentation with minimal disruption to production or quality.
  • Develop and maintain comprehensive program plans, including schedules, resource allocation, risk management, and budgets.
  • Ensure alignment between program objectives, customer requirements, and strategic business goals.
  • Use Smartsheet or similar tools for real-time scheduling, task tracking, and program transparency.
  • Provide structured oversight and improvement planning for existing and legacy programs.

Cross-Functional Leadership

  • Lead cross-disciplinary teams including Engineering, Production, Quality, Tooling, and Supply Chain.
  • Facilitate communication and coordination across departments, vendors, and customers to ensure unified progress.
  • Drive accountability through regular team meetings, status updates, and collaborative problem-solving sessions.

    • Customer Engagement & Relationship Management

  • Serve as the primary point of contact for customer communications throughout the program lifecycle.
  • Establish and maintain strong client relationships, ensuring satisfaction through responsiveness, transparency, and results.
  • Provide consistent updates on program milestones, challenges, and solutions, ensuring full alignment with customer expectations.

    • Process Improvement & Operational Excellence

  • Champion continuous improvement initiatives to optimize manufacturing efficiency, reduce waste, and improve process capability.
  • Analyze KPIs and program performance metrics to identify trends, issues, and improvement opportunities.
  • Promote Lean, Six Sigma, and other data-driven methodologies to deliver measurable operational gains.

    • Regulatory, Quality & Compliance Oversight

  • Ensure all programs adhere to relevant medical device regulations and standards, including FDA (21 CFR Part 820), ISO 13485, and customer-specific quality requirements.
  • Partner with Quality and Regulatory teams to integrate validation, risk analysis (e.g., DFMEA / PFMEA), and document control into program execution.
  • Oversee and support quality assurance activities, ensuring timely resolution of non-conformances and audit readiness.

    • Technical & Industry Expertise

  • Leverage knowledge of injection molding, plastics processing, and medical assembly methods to inform decisions and guide technical discussions.
  • Use ERP systems (IQMS, Epicor, SAGE 100, or equivalent) to manage materials, resources, production schedules, and cost tracking.
  • Ensure designs for manufacturability and scalability, working closely with engineering teams to meet program and production readiness goals.

    • Budget, Resource Management & Reporting

  • Develop and manage detailed budgets, ensuring effective use of personnel, equipment, and materials.
  • Monitor financial performance and ensure adherence to project cost constraints.
  • Provide accurate and timely reporting on program status, risks, corrective actions, and financial performance.
  • Maintain clear, complete documentation including program plans, validation reports, quality records, and communications history.

    • Qualifications

  • Bachelor's degree in Engineering, Manufacturing, Industrial, Mechanical, or a related technical field.
  • 5+ years of program or project management experience in a regulated manufacturing environment, ideally within medical devices or injection molding.
  • Strong technical understanding of manufacturing operations, plastics processing, quality systems, and validation practices.
  • Proficiency in project management tools (e.g., Smartsheet, Microsoft Project) and ERP systems (IQMS, SAGE 100, Epicor).
  • Exceptional leadership, communication, and stakeholder management skills.

    • Preferred Qualifications

  • PMP or equivalent project management certification.
  • Certification or training in Lean Manufacturing, Six Sigma, or continuous improvement methodologies.
  • Advanced knowledge of ISO 13485, FDA QSR, and other relevant medical manufacturing regulations.
  • Experience managing multiple concurrent projects in a high-mix, fast-paced production environment.

    • Other Requirements

  • Support of Current Programs : Responsible for managing and optimizing in-process and legacy programs, including timeline adjustments, cost improvements, and process enhancements.
  • Program Relocation : Lead and coordinate the transfer of manufacturing programs from one facility to another, ensuring full validation, equipment readiness, and documentation continuity.
  • Travel : Occasional travel (up to 20-30%) may be required to visit customer sites, vendors, or internal manufacturing locations to support launches, relocations, validations, or customer reviews.
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    Program Manager • Tempe, AZ, USA

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