Manufacturing Process Engineer

2 weeks ago


Tucson, Arizona, United States Katalyst Healthcares and Life Sciences Full time
Key Responsibilities:
  • Design and execute manufacturing workflows that adhere to FDA and ISO Quality Systems standards for Medical Devices. Demonstrate familiarity with various industry concepts, practices, and methodologies.
  • Utilize experience and judgment to strategize and achieve objectives, undertaking a variety of tasks as needed.
  • At advanced levels, may oversee and guide the efforts of team members.
  • A high degree of creativity and independence is anticipated.
  • This role typically requires a Bachelor's or Master's degree along with 5-8 years of relevant experience.
  • The position generally reports to an Engineering Team Leader or Production Team Leader.
  • The employee receives guidance through broadly defined goals, with responsibilities including achieving team objectives in safety, quality, cost, delivery, employee engagement, asset management, team development, and supervision of other staff as necessary.
  • Recognized for technical expertise in process engineering, the employee collaborates within the technical team framework to support trials and capital projects aimed at enhancing innovation capabilities while maintaining flexibility and sensitivity to both personal and organizational needs. Responsibilities may vary widely based on assignments and typically include:
  • Project oversight
  • Leading project teams of 3 to 15 individuals
  • Managing single or multiple projects
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 company policies, procedures, and training, including ISO 14001 standards.
  • Quality: Enhance process capabilities to minimize defects and variability. Identify, develop, and implement products, processes, materials, systems, and procedures to meet business goals while complying 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 to be recognized for guidance in the application of engineering and maintenance principles.
  • Security and Documentation: Provide direction on security and documentation practices to ensure data retrieval and protection of proprietary information.
  • Problem Solving: Identify, define, and address problems or opportunities to meet unit objectives.
  • Internal Control: Lead assigned projects/tasks to fulfill unit objectives in alignment with corporate policies, emphasizing CFI and Internal Control.
  • Communications: Maintain clear and timely communication with supervisors, subordinates, and other stakeholders. Ensure information is conveyed effectively without being intrusive.
  • Human Resource Development: Assist in the supervision and development of others in areas of expertise.
  • Controlling: Formulate specific action plans for critical tasks, adhere to these plans, anticipate challenges, and adjust as necessary while holding team members accountable for their deliverables.
  • Customer Expectations: Provide process engineering support to resolve process and equipment challenges and offer guidance on process and qualification trials.


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