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Process Engineering Specialist

2 months ago

Tucson, Arizona, United States Katalyst Healthcares and Life Sciences Full time
Key Responsibilities:
  • Design and implement manufacturing workflows that adhere to FDA and ISO Quality Systems standards specifically for Medical Devices. Demonstrate familiarity with various industry concepts, practices, and methodologies.
  • Utilize experience and judgment to strategize and achieve objectives, undertaking a diverse range of tasks.
  • At advanced levels, provide leadership and guidance to team members.
  • Expect a significant degree of creativity and independence in decision-making.
  • This role is suited for individuals with a Bachelor’s or Master’s degree coupled with 5-8 years of relevant experience.
  • Typically reports to an Engineering or Production Team Leader.
  • Operate under broadly defined objectives, focusing on achieving team goals related to safety, quality, cost efficiency, delivery, employee engagement, asset management, and team development.
  • Recognized for technical expertise in process engineering, contributing to the technical team’s efforts in trials and capital projects aimed at enhancing innovation capabilities while maintaining flexibility and sensitivity to organizational needs.
  • Project responsibilities may vary widely, including:
    • Leading projects with teams ranging from 3 to 15 members.
    • Managing single or multiple projects simultaneously.
Required Qualifications:
  • Safety: Actively promote and engage in loss control management by applying Safety Principles, Lean/Six Sigma Manufacturing Principles, and adhering to all relevant regulations.
  • Environmental & Health: Ensure compliance with environmental regulations as stipulated by organizational policies and ISO 14001 standards.
  • Quality: Enhance process capabilities to minimize defects and variability. Identify and implement innovative products, processes, materials, and systems to meet business objectives and comply with federal regulations.
  • Diversity: Lead and supervise in a manner that attracts, develops, and retains top talent while fostering an inclusive environment.
  • Design and Development: Spearhead the initiation, design, and development of manufacturing and support processes to meet unit objectives.
  • Technical Knowledge: Cultivate expertise and skills to be recognized as a resource in engineering and maintenance principles.
  • Security and Documentation: Provide oversight in data security and documentation practices to safeguard proprietary information.
  • Problem Solving: Identify, define, and address challenges to meet unit objectives effectively.
  • Internal Control: Lead projects to align with corporate policies, emphasizing internal controls.
  • Communications: Maintain clear and effective communication with supervisors, team members, and stakeholders, ensuring timely and accurate information sharing.
  • Human Resource Development: Mentor and assist in the professional growth of others in the area of expertise.
  • Controlling: Develop actionable plans for critical tasks, adhering to these plans while anticipating and addressing potential issues.
Key Relationships:
  • Collaborate with Manufacturing, Converting, and Leadership Teams to provide process engineering support and guidance on process and qualification trials.