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• A

  Program Manager  

  Aptyx

  full_time - Tempe

  Posted: 05/06/2025

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  Job DescriptionJob DescriptionAs a Program Manager in our medical inje... Read More

  Job DescriptionJob Description

  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 SAGE 100, 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 (SAGE 100, 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.

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• A

  R&D Project Manager  

  Aptyx

  full_time - Charlotte

  Posted: 14/05/2025

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  Job DescriptionJob DescriptionJob Description: R&D Project ManagerPosi... Read More

  Job DescriptionJob Description

  Job Description: R&D Project Manager

  Position: R&D Project Manager

  Location: Charlotte, NC

  Department: Development

  Reports to: Director of Development

  Company Overview:

  At Aptyx, a new name backed by 70 years of expertise, we bring together the aptitude and excellence of more than a dozen companies with decades of experience helping customers in the life sciences and other demanding industries solve complex manufacturing problems with confidence so they can create more good things in the world. We are committed to delivering high-quality products and services to our customers worldwide. We are seeking a talented and experienced R&D Project Manager to join our dynamic team and contribute to our mission of excellence and innovation.

  Job Summary:

  The R&D Project Manager position performs the function of design engineer and group manager for product development work on medical devices in the Development department in support of the Development department's objectives to provide goods and services that meet customers' requirements for quality, quantity, and timeliness. The primary goal of the R&D Project Manager is to lead and coordinate project engineers, technicians, and assemblers to conduct development projects on time and on budget that meet the customer's objectives, bringing the projects to successful conclusions that meet all the clients' objectives. The R&D Project Manager will coordinate and delegate activities within the Aptyx Charlotte team, provide guidance to projects, and guide engineers to work towards successful project deliverables and meet the expectations of clients. In some cases, the engineering manager may also serve as the project manager.

  Key Responsibilities:

  • Customer Satisfaction: Prepare and support product development teams to ensure customer satisfaction with the outcome and deliverables of assigned projects. Support communication with the customer to resolve any issues and report project status. Escalate issues as needed for leadership support.
  • Resource Management: Assign team members to projects based on allocated budget and project requirements. Balance workloads within the team and coordinate activities to achieve project goals. Work cross-functionally with other departments to ensure adequate resources are available.
  • Training and Development: Mentor and guide staff on individual projects and career development through regular meetings and performance reviews. Train staff to collaborate with outside vendors to source materials, components, and processing. Manage the Team's hands-on product and process development of catheter, implant, and other disposable products.
  • Financial Management: Support achievement of department financial objectives by managing costs and revenues to achieve profitability goals. Review and approve project invoices.
  • Technical Support: Work with technical lead to provide technical support and troubleshooting for product development and project management. Supervise the preparation of documentation to support the quality system for design functions (project plans, concept documents, FMEA, design input, test results, drawings, etc.).

  • Quality Assurance: Supervise development teams to ensure design and development practices are compliant with Aptyx QMS & applicable regulatory requirements.

  • Sales Support: Participate in the project quotation process by generating and/or reviewing project budgets and timelines.

  • Data Analysis: Utilize data analytics to support efforts to achieve department KPIs and company objectives. Prepare regular reports and presentations for senior management.
  • Continuous Improvement: Recommend and support improvements to SOPs/QMS, business practices, technologies, and other opportunities that improve the quality and consistency of services/products provided to customers while achieving business objectives.
  • Additional Responsibilities: This position may also include other duties as assigned to support the overall objectives of the Development department and the company.

  
  

  Qualifications:

  • Education: BS or MS in Engineering is required (Biomedical or Mechanical is preferred).
  • Experience: Minimum of 8 years of experience in medical device development, 10+ years preferred. Previous supervisory and/or management experience in the medical device field preferred. US and International Regulatory requirements, quality management systems requirements, and varied medical device applications experience are highly preferred for understanding project requirements.
  • Technical Skills: Technical skills must include disposable device design and development background, materials knowledge, and prototyping. Experience with project and/or program management of medical devices.

  • Problem-Solving: Excellent analytical and problem-solving skills, with the ability to identify root causes and implement effective solutions.
  • Communication: Strong communication and interpersonal skills, with the ability to work effectively in a multicultural and cross-functional team environment.
  • Travel: May require occasional domestic and international travel.

  Benefits:

  • Competitive salary and performance-based bonuses
  • Comprehensive health, dental, and vision insurance
  • Retirement savings plan with company match
  • Paid time off and holidays
  • Professional development and training opportunities
  • Relocation assistance (if applicable)

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