Operations Engineer - Medical Devices & Change Control

Cerapedics, Inc; Westminster (CO); On-site; USD 95,000 - 136,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Life insurance

401k matching

Paid time off

Long-term disability

Target bonus

Job summary

Cerapedics, Inc. in Westminster, Colorado, seeks an Operations Engineer to support the production of innovative bone repair technologies.

You will work within Technical Operations to drive changes through the change control process and coordinate testing activities with cross-functional teams and suppliers. The role emphasizes evaluating material and process changes, maintaining regulatory compliance, and delivering clear project status updates to leadership.

Qualifications

• Bachelor’s degree in engineering or scientific discipline; 3–5 years experience in progressive roles.
• Experience with medical devices or pharmaceuticals is preferred.
• Knowledge of FDA and ISO guidelines for medical devices or pharmaceuticals.

Responsibilities

• Ensure that changes (raw materials, processes, equipment) meet requirements (FDA, ISO, quality systems).
• Monitor regulatory changes and ensure product compliance.
• Support Engineering Change Control Process and assess changes with stakeholders.
• Collaborate with cross-functional teams and suppliers on testing and qualification.

Skills

Engineering

Regulatory knowledge

Analytical skills

Cross-functional

Communication

Education

Bachelors in engineering or science

MBA preferred

Job description

Cerapedics, Inc. in Westminster, Colorado, seeks an Operations Engineer to support the production of innovative bone repair technologies.

You will work within Technical Operations to drive changes through the change control process and coordinate testing activities with cross-functional teams and suppliers. The role emphasizes evaluating material and process changes, maintaining regulatory compliance, and delivering clear project status updates to leadership.