Process Documentation Technician - Grow into Process Engineer

Lowell Inc.; Lowell (MA); Hybrid; USD 55,000 - 75,000; Full time

Benefits offered by this job

Medical, Dental, Vision

Life Insurance

401k with 3% employer contribution

Profit‑Sharing plan

Job summary

Lowell is seeking a Process Engineering Technician to document and optimize manufacturing processes for high‑mix medical device production. You will capture tribal knowledge, define parameters, and develop clear work instructions to ensure consistent, conforming parts on the shop floor.

Ideal candidates are early in their careers, eager to learn, and capable of working hands‑on with operators and engineers. The role offers growth into a process engineering path within a regulated environment.

Qualifications

• Bachelor's degree in STEM disciplines.
• Zero to two years of manufacturing experience preferred but not required.
• Strong technical writing skills to clearly communicate process steps to a shop floor audience.
• Familiarity with SPC concepts and a willingness to develop proficiency on the job.
• Hands‑on orientation with equipment and operators in a production environment.
• Familiarity with FDA 21 CFR Part 820 and ISO 13485 is a plus but not mandatory.
• Proficiency with Word, Excel, and PowerPoint; ERP experience is advantageous.

Responsibilities

• Document existing secondary operations processes by working with operators and engineers.
• Create detailed, step‑by‑step work instructions with visuals and inspection criteria.
• Audit routings and instructions; identify gaps and implement improvements.
• Ensure ERP routing data reflects actual production sequences and times.
• Assist in process validations (IQ/OQ/PQ) and document results per FDA/ISO 13485.
• Assist in developing and maintaining process FMEAs and control plans for secondary operations.
• Support root-cause analysis for nonconformances and document corrective actions.
• Collect process data for SPC and capability studies to monitor and characterize processes.
• Document new processes during NPI and ensure readiness before production handoff.
• Support engineering change orders by updating instructions and routing data on the shop floor.
• Train operators on updated work instructions and confirm understanding.
• Collaborate with applications and quality engineering to align documentation with programming intent.

Skills

Technical writing

Shop floor intuition

Quality systems awareness

Data analysis basics

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.

About Lowell

Lowell is the premier partner for the development and production of technologically advanced, implantable medical devices for the cardiovascular, spine, trauma and extremities markets. We manufacture components and assemblies that save lives and improve quality of life.

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.
• Lowell offers a competitive compensation and benefits package including Medical, Dental, Vision, Life Insurance, 401k Retirement Plan with 3% employer contribution, and Profit-Sharing plan.

If you are a highly motivated individual who takes pride in their work, we would love to hear from you. Please submit your resume to [e-mail]

This description covers the primary purpose and principal duties of the job. It is not designed to be a complete list of all the duties and responsibilities required of this position. Duties, responsibilities, and activities may change at any time with or without notice.

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