About the Company
The company is a leading contract manufacturer specializing in precision engineering solutions, including medical device manufacturing, metal injection molding, precision machining, and advanced production technologies. It serves global clients across industries and supports the full product lifecycle from development to mass production.
Roles & Responsibilities
We are looking for a dedicated Project Engineer to join our team.
The Project Engineer will be responsible for managing engineering projects within medical device contract manufacturing, ensuring compliance with regulatory standards and successful delivery from concept through production.
You will work closely with cross-functional teams to establish process flows, resolve manufacturing issues, and ensure products meet quality, regulatory, and customer requirements.
What's in it for you
- Exposure to end-to-end medical device project lifecycle
- Work within a regulated environment aligned with ISO 13485 and FDA standards
- Collaboration with cross-functional engineering and production teams
- Opportunity to gain hands-on experience in validation and project execution
- Structured and quality-driven manufacturing environment
- Career development within a growing engineering organization
Responsibilities:
- Manage project schedules and oversee assembly processes for medical devices or equipment.
- Ensure compliance with regulatory standards such as ISO 13485 and FDA 21 CFR Part 820 (QSR).
- Lead or support IQ/OQ/PQ (Installation, Operational, and Performance Qualification) activities.
- Develop and maintain engineering documentation including procedures, process flows, quality plans, drawings, and specifications.
- Coordinate with cross-functional teams to resolve manufacturing and process-related issues.
- Track project progress and ensure milestones are met within timeline and quality standards.
- Interpret customer requirements and translate them into effective engineering solutions.
- Communicate with stakeholders on project updates and technical requirements.
Requirements:
- Bachelor's Degree or Diploma in Mechanical, Electrical/Electronic Engineering, or related field.
- Minimum 2 years of experience in project engineering, coordination, or related role.
- Strong understanding of medical device regulations and quality standards.
- Familiarity with validation processes (IQ/OQ/PQ) is preferred.
- Strong communication and stakeholder management skills.
- Detail-oriented with good problem-solving abilities.
- Able to work in a structured, fast-paced manufacturing environment.
