Medical Process Engineer: Validation & 3D Printing Ops

Materialise NV; Plymouth, Northern (MI, KY); Hybrid; USD 85,000 - 120,000; Full time

Job summary

Materialise Medical in Plymouth, MI is seeking a Medical Process Engineer to join the on-site US team. You will work with the Production group on 3D printing, post-processing, cleaning and production planning, applying a hands-on engineering approach to support development and operations.

You will identify and implement process improvements aligned with medical quality standards, maintain validation programs, and create documentation and training to ensure operational success.

Qualifications

• Master degree in engineering or equivalent through experience.
• Several years in a process (validation) engineering role in highly regulated industries (medical devices, pharma, or aerospace).
• Quality oriented with attention to detail and problem-solving ability.
• Proactive, self-organized and takes ownership of tasks.
• Strong coordination and willingness to learn.

Responsibilities

• You work with the global Production team on topics related to 3D printing, post-processing, cleaning & production planning.
• Your hands-on engineering approach makes you a GoTo for development & operational questions.
• Identify, define, and implement process improvement following medical quality standards on documentation and validation of your work.
• Data collected in validation & operational setting help continuously improve operational quality and efficiency.
• Maintain existing validation programs and complete new equipment, product and process validations.
• Translate this into operational success by providing correct process documentation (work instructions), operator training and support.
• Collaborate with stakeholders from operations, device development, biosafety, research, quality and regulatory teams.

Skills

Engineering degree

Process validation

Quality oriented

Troubleshooting

Proactive work ethic

Self-organized

Ownership

Coordination

Education

Master's degree in engineering

Job description

Materialise Medical in Plymouth, MI is seeking a Medical Process Engineer to join the on-site US team. You will work with the Production group on 3D printing, post-processing, cleaning and production planning, applying a hands-on engineering approach to support development and operations.

You will identify and implement process improvements aligned with medical quality standards, maintain validation programs, and create documentation and training to ensure operational success.