Title: Manufacturing Engineer
Location : Waterloo, Ontario, Canada & Delaware, United States
Duration : 12 Months
Role Summary:
We are looking for a Manufacturing Engineer with experience in the medical device industry to support and improve manufacturing processes, ensure product quality, and maintain compliance with regulatory standards. The role involves working closely with cross-functional teams to drive efficient and reliable production operations.
Key Responsibilities:
- Develop, implement, and optimize manufacturing processes and workflows
- Provide technical support to production and troubleshoot process-related issues
- Ensure compliance with FDA regulations, ISO 13485, and GMP requirements
- Support process validation activities and maintain related documentation
- Collaborate with Quality, R&D, and Supply Chain teams
- Drive continuous improvement initiatives using Lean principles
- Support change control, CAPA, and root cause analysis activities
Required Qualifications:
- Bachelor’s degree in Engineering or related field
- 3–7 years of manufacturing experience in medical device or regulated industry
- Strong understanding of manufacturing processes and quality systems
- Experience with process validation and documentation
- Good problem-solving and communication skills
Preferred Qualifications:
- Experience with Lean Manufacturing or Six Sigma
- Familiarity with cleanroom manufacturing environments
- Experience supporting audits and regulatory inspections
