Senior Process Engineer

Intepros; Kalamazoo (MI); Vor Ort; USD 85.000 - 125.000; Vollzeit

Zusammenfassung

Intepros in Kalamazoo, MI is seeking a Senior Process Engineer to support validation, equipment integration and product transfers in a medical device manufacturing setting.

The role emphasizes hands-on data analysis, cross-functional collaboration, and strict GMP compliance. You will lead validation activities, develop PFMEAs, Control Plans, and PPAPs, drive process improvements across manufacturing lines, mentor junior engineers, and support tech transfers in a fast-paced medical device setting.

Qualifikationen

• Bachelor's degree in Engineering or related technical field.
• 4+ years of relevant engineering experience in medical devices.
• Experience with process and equipment validation, PPAP, and equipment integration.
• Knowledge of Six Sigma and statistical methods.
• Strong problem-solving and cross-functional collaboration skills.

Aufgaben

• Execute process validation activities, including data collection and reporting.
• Set up, troubleshoot, and optimize manufacturing equipment and fixtures.
• Collaborate with Quality, Operations, Engineering, Materials, and other teams for production readiness.
• Develop and review process qualification documentation (PFMEAs, Control Plans, SOPs, PPAPs).
• Lead or review process review meetings and manage project workstreams.
• Support product transfers and cost-improvement initiatives while maintaining GMP compliance.

Kenntnisse

Process validation

Equipment integration

Six Sigma

Statistical methods

Project management

Cross-functional collaboration

GMP compliance

Data analysis

Manufacturing

Problem solving

Ausbildung

Bachelor's degree in Engineering

Jobbeschreibung

We're Hiring: Senior Process Engineer

We're actively seeking a qualified Senior Process Engineer to support manufacturing process validation, equipment integration, and product transfers within a medical device manufacturing environment.

Key Responsibilities

• Execute process validation activities, including running samples, collecting and analyzing data, and preparing validation reports.
• Set up and troubleshoot manufacturing equipment, tooling, fixtures, and assembly line processes.
• Collaborate with Quality, Operations, Engineering, Materials, and cross-functional teams to support production readiness and process improvements.
• Develop and review process qualification documentation, including PFMEAs, Control Plans, SOPs, and PPAPs.
• Analyze equipment performance, establish operating parameters, and conduct experimental testing and results analysis.
• Support product transfers and cost-improvement initiatives while ensuring compliance with GMP and safety requirements.
• Lead or independently review process review meetings and manage assigned project workstreams.

Qualifications

• Bachelor's degree in Engineering or a related technical discipline.
• 4+ years of relevant engineering experience.
• Experience with process and equipment validation, PPAP, and manufacturing equipment integration and troubleshooting.
• Knowledge of statistical methods, process development, and continuous improvement methodologies, including Six Sigma.
• Strong problem-solving, project management, communication, and cross-functional collaboration skills.
• Medical device industry experience strongly preferred.