Location
Boston, MA | United States
Job description
Hello,
Hope you are doing well.
This is Vydehi and I'm a recruiter at Intellectt, Inc. Please find the job description and reach out to me with an updated copy of your resume. You can send it to [email protected] or call me at +1(732) 355- 7412
Job Title: Manufacturing Engineer
Work Site/Location: Boston, MA
Duration: 12 Months
Work Schedule: 8:30am-5pm
Job Description:
- Support EU MDR remediation efforts and enhance manufacturing operations.
- Oversee projects to improve existing processes and develop new ones.
- Address gaps in EU MDR technical files for operations and packaging.
- Manage complex remediation projects with a focus on process engineering and risk management.
- Document and coordinate project tasks according to regulatory standards.
- Enhance manufacturing processes, troubleshoot issues, and ensure compliance.
Qualifications: - Bachelor's degree in Engineering (Mechanical, Pharmaceutical, Chemical, or Biomedical).
- 3+ years in medical device manufacturing engineering.
- Familiarity with QSR, Design Control, Process Validation, ISO, and Regulatory guidelines.
- Experience with Statistical Process Control tools.
Key Skills: - Process Engineering
- Project Management
- Change Control
- CAPA/Root Cause Investigations
- Validation
Job tags
Salary
