Overview The Process Engineering Technician supports the development, documentation, and continuous improvement of manufacturing processes within a high-mix medical device contract manufacturing environment. The primary responsibility of this role is to create robust process documentation for existing operations by capturing tribal knowledge, defining process parameters, and developing clear work instructions that ensure consistent production of conforming parts. This hands-on, shop-floor position is ideal for individuals early in their careers who seek to grow into a process engineering role through direct experience. Primary Job Duties Document existing secondary operations processes, such as blasting, mass finishing, laser marking, cleaning, and assembly, by working directly with operators and engineers to capture current practices, define process parameters, and formalize informal knowledge into controlled documentation. Create detailed, step-by-step work instructions that include visual aids, parameter callouts, and inspection criteria. These instructions are designed to eliminate reliance on tribal knowledge, enabling any trained operator to consistently produce conforming parts. Audit existing production routings and work instructions to identify any gaps in documentation, parameter definition, or acceptance criteria. Recommend and implement improvements to address these gaps. Ensure that ERP routing data accurately reflects actual production processes, including operation sequences, cycle times, and resource assignments. Identify and correct any discrepancies as they are found. Support engineers in developing and executing process validations (IQ/OQ/PQ) by assisting with data collection, protocol execution, and documentation of results in compliance with FDA and

ISO 13485

standards. Assist in the development and maintenance of process FMEAs and control plans for secondary operations. Participate in root cause analysis for process-related nonconformances by gathering data, documenting findings, and supporting the implementation of corrective actions. Collect and organize process data to support statistical analysis, including SPC charting and capability studies, while developing a practical understanding of these tools and their use in characterizing and monitoring processes. Support engineers during new product introductions by documenting new processes as they are developed, ensuring documentation is complete and accurate prior to production handoff. Take part in engineering change orders by helping to evaluate documentation impacts, updating work instructions and routing data, and verifying that changes are properly implemented on the shop floor. Train operators on new and updated work instructions, confirming understanding and promoting consistent execution. Collaborate with applications engineering and quality engineering teams to ensure that process documentation aligns with programming intent and quality requirements. Requirements Bachelor's degree in a STEM discipline (engineering, science, technology, or mathematics). Candidates with an engineering degree and no experience are encouraged to apply. Zero to two years of experience in a manufacturing environment. While direct experience is appreciated, it is not required. Aptitude, curiosity, and a willingness to learn on the shop floor are most important. Strong technical writing skills with the ability to communicate process steps clearly and thoroughly to a shop floor audience. General awareness of statistical process control (SPC) concepts and an openness to develop proficiency through on-the-job application. Hands-on orientation and comfort working directly with equipment, tooling, and operators in a production environment. Familiarity with

FDA 21 CFR

Part 820 and

ISO 13485

regulations is a plus but not mandatory. Proficiency with Microsoft Office applications (Word, Excel, PowerPoint). Experience with ERP systems is advantageous.

Pay:

$25.00 - $30.00 per hour Expected hours: 40.0 per week

Benefits:

401(k) Dental insurance Health insurance Health savings account Life insurance Referral program Retirement plan Vision insurance

Work Location:

In person