Program Manager - Aptyx

As a Program Manager in our medical injection molding and assembly manufacturing division, you will be the driving force behind delivering high-quality, regulatory-compliant products to market, guiding projects from concept through to successful product launch. This position is pivotal to our commitment to providing exceptional service and innovative solutions to customers, and it demands an individual with both strategic vision and hands-on leadership abilities. The Program Manager will oversee project timelines, resources, and cross-functional collaboration, ensuring customer requirements are met through meticulous planning, robust problem-solving, and a proactive approach to risk management.

Key Responsibilities:

Project Leadership & Strategy

• Lead end-to-end project management, including project scoping, planning, execution, and delivery. Maintain an exceptional level of oversight across each phase of the product lifecycle.
• Define and implement project strategies that align with customer requirements, regulatory standards, and company goals.
• Utilize Smartsheet or other project management tools for scheduling, tracking progress, and managing resources effectively.

Customer Relationship Management & Communication

• Act as the primary liaison for customer engagements, proactively managing customer expectations, understanding specific project requirements, and addressing inquiries and concerns.
• Communicate project milestones, updates, and potential risks clearly and frequently, ensuring full customer alignment and satisfaction throughout the project lifecycle.
• Build and maintain strong relationships with customers, demonstrating a commitment to their success and high-quality standards.

Cross-functional Collaboration & Team Coordination

• Collaborate closely with Quality Engineers, Tooling Engineers, and other team members to align on product specifications, validation processes, and manufacturing requirements.
• Lead regular project team meetings, fostering a collaborative, solutions-focused environment to address challenges and maintain momentum on all project activities.
• Ensure validation, regulatory, and compliance standards are fully integrated into the project plan, anticipating challenges and adjusting timelines as necessary to meet industry standards.

Risk Management & Problem-Solving

• Identify potential project risks early and develop risk mitigation plans, taking a proactive approach to address issues before they impact timelines or quality.
• Analyze data, quality reports, and customer feedback to make informed, data-driven decisions that align with project objectives and regulatory requirements.
• Apply problem-solving skills to quickly adapt to changes, troubleshoot issues, and make course corrections to keep projects on track.

Technical & Industry Expertise

• Leverage expertise in IQMS or Epicor ERP systems to manage project resources, budgets, and inventory needs, ensuring transparency and efficiency in resource allocation.
• Draw on your understanding of plastics, injection molding processes, and medical device manufacturing standards to guide decisions, ensuring all technical aspects align with project specifications.
• Champion continuous improvement, identifying and implementing best practices that enhance quality, reduce costs, and improve process efficiency.

Required Qualifications:

• Educational Background: Bachelor's degree in Engineering, Project Management, or a related technical field; PMP certification preferred.
• Experience: 5+ years of program or project management experience in medical injection molding, medical device manufacturing, or a similar regulated manufacturing environment.
• Technical Proficiency: Expertise in project management software (Smartsheet or equivalent), ERP systems (IQMS or Epicor), and a solid understanding of plastics and injection molding processes.
• Quality & Compliance Knowledge: Familiarity with medical device regulatory standards, validation processes, and quality assurance requirements.
• Analytical Skills: Strong analytical, critical thinking, and problem-solving skills, with a track record of making informed, data-driven decisions.

Key Skills and Competencies:

• Organizational Skills: Demonstrated ability to manage multiple priorities, deliverables, and stakeholders effectively and efficiently.
• Customer Focus: Proven success in customer service, relationship building, and maintaining alignment between project goals and customer expectations.
• Leadership & Collaboration: Excellent interpersonal and leadership skills, with a focus on collaborative problem-solving and team building.
• Attention to Detail: Precision and rigor in documentation, scheduling, and reporting, ensuring complete project transparency and accountability.

Preferred Qualifications:

• PMP or equivalent project management certification.
• Advanced knowledge of regulatory requirements for medical device manufacturing (e.g., FDA, ISO 13485).
• Experience in lean manufacturing, Six Sigma, or continuous improvement methodologies.