Project Engineer (Validation and Technical Transfer).

Job Description:

Independently, or under limited or null supervision, works on complex by nature assignments, which require considerable criteria, judgment and initiative in order to solve problems and issue recommendations in attainment with a defined timeline. The project engineer is responsible for designing, communicating and implementing an operational plan for completing engineering-based projects. Prepares designs, project controls and specifications,
schedules, installation, testing and commissioning of new equipment, tooling, lines, fixtures, etc. Monitors progress and performance against the project plan. Identifies, develops and gathers the necessary resources to complete the project.

Responsibilities:

• Benchmarks and advises leadership on Validation and Technical Transfer supply chain project plans and key
  milestones that produce deliverables aligned with customer’s operational needs and requirements.
• Performs process validations on new and transferred processes/equipment for subsequent operational
  integration and supply chain implementation.
• Identifies any non-conformance and subsequent corrective and preventive actions, by documenting,
  investigating, and conducting root cause analysis, and successfully implementing corrective actions.
• Examines outputs of Project Engineering Technicians by supporting and enforcing site-specific safety and
  industrial hygiene requirements.
• Identifies and communicates, in a timely manner, any Project Engineering issues or concerns to the next
  management level.
• Coaches more junior colleagues in techniques, processes, and responsibilities.
• Understands and applies the company Credo and Leadership Imperatives in day-to-day interactions
  with team.
• Provides solutions to the problems in manufacturing of current and new models.
• Performs basic operational diagnostics test. Solves problems and disconnects components, subassemblies and
  manufacturing systems, processes and equipment with the purpose of isolating failures, determining the
  solution and performing the necessary training.
• Starts, adjusts and operates basic laboratory and manufacturing equipment.
• Can provide recommendations and technical support for new projects, process improvements and quality
  investigations.
• Follows the Convenient Information Retention Administration Policies and of the Campus, record
  retention program, training and education, Document Retention Notices, Record cleanup, inactive records and
  Information Management, Vital Records if applicable.
• Responsible for following all Company guidelines related to Health, Safety and Environmental practices as
  applicable.
• For those who supervise or manage staff, they are responsible for ensuring that subordinates follow all
  Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do
  so are available and in good condition, if applicable.
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company
  regulations, policies, and procedures.

Requirements:

• Leadership experience.
• Technical and practical ability fundamental for engineering areas applicable to the transfer project.
• Project management experience.
• Ability for the resolution of failures, in aspects or areas of equipment, and manufacturing processes.
• Ability to integrate into work groups.
• Knowledge of catheters and Medical device companies.
• Ability to use measuring and testing equipment associated with specific discipline.
• Advance ability to read and understand technical documentation associated with specific discipline.
• Ability to learn about regulatory requirements (GMP and GDP).
• Ability to use computers and related software.
• Able to work in a Clean Room environment requiring gowning.
• Must have strong communication and interpersonal skills and be able to support cross functional teams
  including Quality, Operations & Engineering.

Experience & Education:

• Engineering, any specialty
• Master’s degree, desirable
• Generally, Requires 2-4 Years Work Experience
• Advanced English
• Effective communication in English and Spanish across functions and both internally/externally