Process Engineer

We are seeking a highly motivated and detail-oriented Process Engineer to join our team. This role is responsible for developing, optimizing, and maintaining manufacturing processes to ensure high-quality production of single use supplies including medical device components. The ideal candidate will have hands-on experience in a manufacturing environment, with a strong background in process engineering, lean manufacturing, and quality systems within a regulated industry.

Responsibilities:

• • Develop, implement, and optimize manufacturing processes
  • Troubleshoots and resolves hardware manufacturing, quality and test issues to support production schedules.
  • Provide corrective actions to fix tooling to minimize downtimes
  • Conduct process validation activities including writing and executing IQ/OQ/PQ Improves manufacturing processes, documentation, yield and test efficiency in collaboration with a multi-disciplined team.
  • Translates engineering design requirements into manufacturing operations sheets, work instructions, tooling and test equipment, workflows and processes.
  • Design, develop, and implement new manufacturing equipment, fixtures, and tools to enhance production capabilities
  • Dispositions non-conforming material with root cause, corrective action and defect analysis as required to prevent recurrence.
  • Reviews design drawings for manufacturability and cost (DFM, DFC).
  • Analyze production data to identify trends, inefficiencies, and opportunities for improvement.
  • Collaborate with cross-functional teams to support new product introductions and process scale-up.
  • Drive continuous improvement initiatives using Lean, Six Sigma, and other methodologies.
  • Troubleshoot process issues and conduct root cause analysis and corrective/preventive actions (CAPA).
  • Support equipment selection, installation, and qualification.
  • Maintain and update process documentation including SOPs, work instructions, and risk assessments.
  • Ensure compliance with FDA, ISO 13485, and other applicable regulatory requirements.
  • Train production staff on new processes, equipment, and best practices.
  • Monitor and improve process yields, cycle times, and overall equipment effectiveness (OEE).
  • Participate in audits and inspections, providing technical support and documentation as needed.
  • Evaluate and implement automation solutions to improve process reliability and reduce labor costs.
  • Manage small to medium-scale engineering projects from concept through execution.
• • • Other responsibilities as assigned

To be considered you’ll need:

• a Bachelor’s degree in STEM
• a minimum of 5 years of relevant work experience within the medical device or other regulated manufacturing environment.
• Strong multidisciplined engineering aptitude, analytical skills and problem-solving skills.
• Experience with Lean Manufacturing and Continuous Improvement activities
• Proficiency with CAD modeling tools
• Strong organization skills with the ability to manage multiple tasks simultaneously.
• Proficient use of Microsoft Office suite (Excel, PowerPoint, Word
• strong knowledge of lean manufacturing, Six Sigma, and statistical process control (SPC).
• experience with validation protocols (IQ/OQ/PQ) and risk management tools (FMEA).
• solid company-centric ideology.
• creative problem-solving skills.
• core values of honesty and respect.
• a thirst for learning.
• the desire to be challenged.

You will thrive if you:

• enjoy an autonomous work environment.
• have a LEAN mindset.
• are the first person to help.
• seek out opportunities to bring added value.

Company Benefits & Perks