Senior Process Engineer

Comrise; Kalamazoo (MI); In loco; USD 95.000 - 135.000; Tempo pieno

Descrizione del lavoro

Comrise is seeking a Senior Process Engineer to support high-impact manufacturing and product transfer initiatives in a regulated medical device environment. The role emphasizes process validation, equipment integration, data analysis, troubleshooting, and continuous improvement to meet quality and safety standards.

The ideal candidate has hands-on experience with medical device manufacturing, equipment validation, and statistical methods for process development, collaborating closely with

Competenze

• Bachelor's degree in Engineering or a related engineering discipline.
• At least 4 years of relevant engineering experience.
• Experience in the medical device industry is required.
• Hands-on experience with equipment and process validation.
• Knowledge of statistical methods used in process development and analysis.
• Experience integrating, troubleshooting, and supporting manufacturing or test equipment.
• Strong analytical, problem-solving, documentation, and cross-functional collaboration skills.
• Ability to work onsite in a manufacturing environment.

Mansioni

• Execute process and equipment validation activities, including running samples on manufacturing equipment, collecting data, analyzing results, and preparing validation reports.
• Evaluate manufacturing and test equipment to establish operating parameters and verify process performance.
• Apply statistical methods to support process development, experimental testing, data analysis, and process optimization.
• Integrate, set up, and troubleshoot manufacturing and test equipment, fixtures, tooling, and assembly line components.
• Support product transfer initiatives by collaborating with cross-functional teams to ensure manufacturing processes are properly qualified and production-ready.
• Develop and maintain process documentation, including PFMEA, Control Plans, SOPs, PPAP documentation.
• Participate in process review meetings and contribute technical recommendations to resolve manufacturing challenges.
• Coordinate with Materials, Quality, Operations, and Engineering teams to ensure assembly lines are ready to receive components and raw materials.
• Identify opportunities for process improvement, cost transformation, and manufacturing efficiency.
• Ensure compliance with GMP, quality standards, and safety procedures.

Descrizione del lavoro

Shift: (flexible hours from 6am-8am start)

Job Overview

We are seeking a Senior Process Engineer to support high-impact manufacturing and product transfer initiatives within a regulated medical device manufacturing environment. This role will focus on process validation, manufacturing equipment integration, data analysis, troubleshooting, and continuous improvement to ensure manufacturing processes meet quality, safety, and performance requirements.

The ideal candidate has experience in medical device manufacturing, equipment validation, statistical methods for process development, and hands‑on manufacturing support. This individual will collaborate closely with Quality, Operations, Engineering, and Materials teams to support production readiness and successful product transfers.

Key Responsibilities

• Execute process and equipment validation activities, including running samples on manufacturing equipment, collecting data, analyzing results, and preparing validation reports.
• Evaluate manufacturing and test equipment to establish operating parameters and verify process performance.
• Apply statistical methods to support process development, experimental testing, data analysis, and process optimization.
• Integrate, set up, and troubleshoot manufacturing and test equipment, fixtures, tooling, and assembly line components.
• Support product transfer initiatives by collaborating with cross-functional teams to ensure manufacturing processes are properly qualified and production-ready.
• Develop and maintain process documentation, including Process Failure Mode and Effects Analysis (PFMEA), Control Plans, Standard Operating Procedures (SOPs), and Production Part Approval Process (PPAP) documentation.
• Participate in process review meetings and contribute technical recommendations to resolve manufacturing challenges.
• Coordinate with Materials, Quality, Operations, and Engineering teams to ensure assembly lines are ready to receive components and raw materials.
• Identify opportunities for process improvement, cost transformation, and manufacturing efficiency.
• Ensure compliance with applicable Good Manufacturing Practices (GMP), quality standards, and safety procedures.

Required Qualifications

• Bachelor's degree in Engineering or a related engineering discipline.
• At least 4 years of relevant engineering experience.
• Experience in the medical device industry is required.
• Hands‑on experience with equipment and process validation.
• Knowledge of statistical methods used in process development and analysis.
• Experience integrating, troubleshooting, and supporting manufacturing or test equipment.
• Strong analytical, problem-solving, documentation, and cross‑functional collaboration skills.
• Ability to work onsite in a manufacturing environment.

Preferred Qualifications

• Experience with PPAP and manufacturing process qualification.
• Experience managing project workstreams, deliverables, and timelines.
• Background in complex problem-solving and root cause analysis.
• Knowledge of Six Sigma, Lean Manufacturing, or continuous improvement methodologies.
• Experience supporting product transfers, manufacturing scale‑up, or production readiness initiatives.