Process Engineer

Job Description

Job Description

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

• 401K
• Health Benefits: Medical, Dental, Vision
• Wellness Program
• Life Insurance
• Corporate Sponsored Events
• Skill growth opportunities
• Short Term Disability
• Ability to Advance
• Working with energetic & creative problem solvers
• A mission worthy of your energy and expertise

Applicants for this position must successfully pass background, drug screen and reference check. It is impossible to list every requirement for, or responsibility of, any position. Similarly, we cannot identify all the skills a position may require since job responsibilities and the Company's needs may change over time. Therefore, the above job description is not comprehensive or exhaustive. The Company reserves the right to adjust, add to or eliminate any aspect of the above description. The Company also retains the right to require all employees to undertake additional or different job responsibilities when necessary to meet business needs.