Associate Manufacturing Engineer

Lowell Inc.; Fort Snelling Unorganized Territory (MN); On-site; USD 65,000 - 78,000; Full time

Job summary

Lowell Inc. is seeking a Process Engineering Technician to support development and documentation of manufacturing processes in a high‑mix medical device contract environment.

You will create robust process documentation, define parameters, and develop detailed work instructions to ensure consistent production of conforming parts. This hands‑on role offers growth on the shop floor, with opportunities to contribute to IQ/OQ/PQ validations, FMEAs, and control plans while collaborating with

Qualifications

• Bachelor's degree in a STEM discipline; engineers encouraged to apply even with no experience.
• Zero to two years of manufacturing experience; willingness to learn on the shop floor.
• Strong technical writing to clearly communicate process steps to shop floor.
• Familiarity with SPC concepts and openness to on‑the‑job training.
• Hands‑on orientation with equipment, tooling, and operators.
• Familiarity with FDA 21 CFR Part 820 and ISO 13485 is a plus.
• Proficiency with Word, Excel, PowerPoint; ERP experience is advantageous.

Responsibilities

• Document existing secondary operations processes with operators and engineers to define parameters and formalize knowledge.
• Create detailed, step‑by‑step work instructions with visuals, callouts, and inspection criteria.
• Audit routings and work instructions; implement improvements.
• Ensure ERP routing data reflects actual processes and correct discrepancies.
• Assist with IQ/OQ/PQ validations and documentation per FDA/ISO 13485.
• Support development of process FMEAs and control plans for secondary ops.
• Contribute to root cause analysis and corrective actions for process issues.
• Collect process data for SPC and capability studies and data analysis.

Skills

Technical writing

SPC concepts

Shop floor

Clear communication

Education

Bachelor's degree in STEM

Tools

Microsoft Office

ERP systems

Job description

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.