Manufacturing Process Engineer

Description

Job purpose

The Manufacturing Process Engineer (MPE) serves as the implementation leader within the Process Engineering team, responsible for executing and sustaining approved process improvements within manufacturing operations. This role translates qualified process changes into stable, repeatable production practices by developing implementation plans, establishing and auditing standard work, training personnel, and identifying sources of process variability. Working closely with the Process Qualification Specialist (PQS), this position supports experimentation and validation activities while ensuring successful transfer of improvements from qualification to full-scale production. The Manufacturing Process Engineer maintains a strong floor presence and applies Lean principles to ensure processes are disciplined, efficient, and sustainable.

Key duties and responsibilities

Process Improvement Implementation

· Lead the structured implementation of approved Process Improvements from qualification through stable production.

· Develop practical implementation plans that ensure sustainable transfer of process changes to Manufacturing.

· Establish, document, and maintain standard work to support implemented improvements.

· Train manufacturing personnel on improved processes and verify operator proficiency through observation and audit.

· Identify and communicate gaps between experimental assumptions and actual production conditions. 

· Maintain presence on the manufacturing floor to reinforce process discipline and adherence to standard work.

· Partner with Process Qualification Specialist to support experimentation, data collection, and execution readiness.

· Collaborate with manufacturing leadership to plan and execute implementation activities with minimal production disruption.

Validation & Qualification Support

· Support execution of IQ/OQ/PQ activities associated with approved process improvements.

· Support data collection, test execution, and coordination of qualification activities within manufacturing operations.

· Compile, analyze, and summarize qualification results to support completion of validation reports.

· Prepare and finalize OQ and PQ summary reports for review and approval.

· Drive all qualification documentation through the QMS system to ensure timely routing, review, approval, and closure.

· Coordinate with Quality, Manufacturing, and the PQS to resolve documentation gaps or review comments.

· Escalate observed deviations or unexpected process performance during qualification execution.

· Support equipment qualification activities as required in coordination with the Equipment Specialist.

Lean & Continuous Improvement

· Apply practical Lean principles during implementation to reduce variability and improve flow.

· Conduct time studies and collect process performance data to support improvement efforts.

· Audit adherence to standard work and provide feedback to ensure sustained performance.

· Identify opportunities to reduce waste and improve process efficiency during day-to-day operations.

· Facilitate Lean training sessions to strengthen practical understanding of applied Lean principles and reinforce a culture of continuous improvement. 

General Responsibilities

· Troubleshoot process issues to maintain consistent production flow.

· Support introduction of new equipment or materials into existing production systems.

· Ensure compliance with FDA, ISO, and internal quality system requirements.

· Perform other duties as assigned.

Qualifications

Required Qualifications:

· Bachelor’s degree in Engineering, Science, or related technical field; or equivalent combination of education and hands-on manufacturing experience.

· Demonstrated applied Lean manufacturing experience in a production environment, including development of standard work, time studies, and implementation of process flow improvements.

· Experience executing process changes within manufacturing operations, including training operators and verifying adherence to standard work.

· Strong working knowledge of process variability, root cause analysis, and data-driven problem solving.

· High proficiency with QMS systems, documentation control processes, and Microsoft Excel for data analysis and reporting.

· Demonstrated ability to drive tasks to completion, follow through on documentation and approvals, and maintain accountability in a fast-paced environment.

· Strong communication skills with the ability to train, coach, and collaborate effectively across Manufacturing, Quality, and Engineering functions.

Desired Qualifications:

· Experience in FDA-regulated manufacturing (medical device preferred).

· Experience supporting validation activities (OQ/PQ execution, data collection, report compilation) in a regulated or structured quality system environment.

· Direct experience finalizing validation summary reports and driving documentation through QMS approval workflows.

· Applied experience utilizing Design of Experiments (DOE) methodology in a production environment.

· Experience facilitating Lean training or coaching manufacturing personnel on Lean principles.

· Familiarity with ISO 13485 or ISO 9001 quality systems.

Equal Opportunity Employment: IMMY is committed to the principle of equal employment opportunity for all employees and applicants for employment and prohibits discrimination and harassment of any kind without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, and local laws. IMMY will not tolerate discrimination or harassment based on any of these characteristics. This policy applies to all terms and conditions of employment, including, but not limited to, recruiting, hiring, promotion, termination, leaves of absence, compensation, and training. 

Background Check Policy: All offers of employment at IMMY are contingent upon clear, acceptable results of a thorough background check. IMMY performs all background checks in compliance with EEOC and FCRA regulations and all other applicable federal, state, and local laws.