Manufacturing Process Engineer

2 weeks ago

Pittsboro, Indiana, United States Gilero Full time

Company Overview:

Gilero is expanding and seeking skilled Process Engineers to assist in the development and production of innovative assembly automation solutions for medical and pharmaceutical delivery systems.

Position Overview:

The selected candidates will be tasked with creating new manufacturing systems for cutting-edge technologies to facilitate the production of medical devices in compliance with industry regulations and standards (ISO 13485 and FDA 21 CFR Part 820). This role encompasses the design and implementation of manufacturing processes, with project scopes ranging from developmental pilots to full-scale commercial production.

Key Responsibilities:

  • Senior roles will act as subject matter experts in electromechanical and automation processes, fostering skill development within the team.
  • Oversee and coordinate external contractors for the installation, troubleshooting, and validation of automated systems and processes for intricate device assembly and testing.
  • Develop and implement new manufacturing capabilities, including process selection, characterization, and qualification through designed experiment methodologies (DOE).
  • Assess new device designs for manufacturability (DFM/DFA).
  • Design process flows and line layouts to optimize efficient, flexible, and scalable manufacturing cells.
  • Apply Lean Thinking, Six Sigma, and 5S principles to create or enhance existing processes.
  • Specify and procure new process equipment for both manual and fully automated production lines.
  • Draft and execute protocols to evaluate manufacturing process capabilities (IQ/OQ/PQ).
  • Create CAD models for testing or assembly fixtures.
  • Establish maintenance protocols for new equipment.
  • Analyze the impact of new process introductions on critical environments.
  • Implement process modifications as required by customer feedback, manufacturing quality concerns, or design alterations.
  • Conduct process risk assessments through PFMEA activities to support both new and existing processes.
  • Maintain the Device Master Record (DMR), ensuring all documentation is complete, accurate, and up-to-date, including process routers, inspection plans, temporary deviations, and non-conformances.
  • Engage in manufacturing investigations and CAPA resolutions to identify enhancements to manufacturing processes.
  • Support quality audits of manufacturing operations.
  • Drive continuous improvement initiatives within the manufacturing area to achieve and surpass operational objectives.
  • Develop process and pricing strategies for customer quotations in collaboration with Tooling, Engineering, Purchasing, and Customer Service.
  • Facilitate the transfer of existing product designs to and from other manufacturing locations.
  • Lead project activities by managing budgets, resources, timelines, and deliverables.
  • Provide engineering expertise to resolve specific technological challenges during development and support the production team during ramp-up and sustaining phases.
  • Communicate effectively with clients and vendors in a technical context.

Qualifications:

  • Bachelor's degree in Engineering or a related technical field.
  • Positions available for both senior and junior levels; a minimum of 3 years of relevant experience in the manufacturing of medical devices is required.
  • Familiarity with medical device regulations (FDA/ISO).
  • Proficiency in SolidWorks, Pro/Engineer, or other 3D CAD modeling software is preferred.
  • Experience with drug filling and handling for combination products is a significant advantage.
  • Ability to program PLC, Arduino, or other motion controllers is a strong plus.
  • Experience in integrating vision systems into manufacturing equipment for in-process inspection and/or motion control is beneficial.

Personal Attributes:

  • Embodies Gilero's Core Values: Collaboration, Integrity, Innovation, and Excellence.
  • Thrives in a dynamic, fast-paced, entrepreneurial environment.
  • A self-motivated individual seeking a career path with opportunities for internal advancement, taking responsibility for core activities while delivering high-quality service to both internal and external clients.
  • Dedicated to excellence and quality service for all customers.
  • Committed to adhering to established policies and procedures while contributing to ongoing improvements.
  • Exhibits excellent communication skills, both verbal and written.
  • Possesses proficient computer skills, including Microsoft Excel and Word.

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