Senior Operations Engineer
Globaltech Medical Devices
full-time
Posted on:
Location Type: Office
Location: Westminster • Colorado • United States
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Salary
💰 $133,000 - $167,000 per year
Job Level
About the role
- Responsible for ensuring that any changes (e.g., raw materials, regulations, equipment, process) meet requirements (e.g., FDA, BSI, quality systems).
- Manage all critical external vendor partners so that we can proactively manage changes.
- Drive the Engineering Change Control Process.
- Actively participate in management of appropriate engineering change controls and reviews.
- Evaluate changes and execute appropriate qualification activities.
Requirements
- Bachelor’s degree in engineering or Scientific discipline or an equivalent combination of education and work experience.
- Advanced degree or MBA preferred.
- Minimum of 7 years of experience with progressively increasing responsibility or complexity.
- Minimum of 3 years in medical device, biomedical, or pharmaceutical industries.
- Experience with orthopedics or spinal medical devices is highly desirable.
- Strong analytical and problem-solving skills.
- Knowledge of FDA and ISO guidelines for medical devices.
Benefits
- Medical and dental insurance
- Group life insurance
- 401k matching
- Long term disability
- Potential target bonus
- Paid time off
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
engineering change controlqualification activitiesregulatory compliancequality systemsanalytical skillsproblem-solving skills