Manufacturing Engineer
About Your New Employer
- Join a pioneering company in the development of advanced medical devices for global markets.
- Work at the forefront of medical technology with a highly skilled, cross-functional team and a strong culture of continuous improvement.
- Be part of a growing organization committed to quality, innovation, and compliance with international standards such as ISO 13485, FDA 21 CFR Part 820, and EU MDR directives.
- This job is fully onsite.
About Your New Job
As a Manufacturing Engineer, you will:
- Provide ongoing engineering support to the manufacturing line, ensuring efficient and stable operations.
- Lead troubleshooting and root cause analysis for complex equipment, processes, or material issues, implementing effective corrective and preventive actions (CAPAs).
- Manage process and equipment change control, including all validation and associated documentation, per rigorous QMS and regulatory standards.
- Identify and deploy new tools, jigs, fixtures, or process solutions to improve manufacturing efficiency, product quality, and reliability.
- Drive and deliver continuous improvement initiatives using Lean Manufacturing, Six Sigma, or other recognized methodologies.
- Collaborate with multidisciplinary teams in risk management, process development, and equipment or product validation projects (IQ, OQ, PQ).
- Develop, review, and maintain technical documentation, SOPs, work instructions, and visual standards.
- Ensure a GMP-compliant, safe, and orderly work environment, and support ongoing staff training on manufacturing processes.
What Skills You Need
- Bachelor’s degree in Engineering (Mechanical, Manufacturing, Biomedical, or related disciplines).
- 3–5 years of hands-on experience in the medical device or pharmaceutical industry, with a background in production equipment operation/maintenance and process improvement.
- Sound knowledge of ISO 13485, MDR, and FDA regulatory requirements; experience working within a QMS.
- Strong analytical and troubleshooting skills, ownership mentality, and ability to work both autonomously and collaboratively.
- Proficiency in process improvement tools (Lean, Six Sigma—Green Belt an advantage).
- Excellent communication, teamwork, and documentation capabilities.
- Strong organizational skills and ability to juggle multiple priorities in a fast-moving production environment.
What's on Offer
- Competitive salary, commensurate with experience.
- Opportunities for ongoing career growth, professional development, and training (including further Lean/Six Sigma certification).
- Be part of innovative teams driving exciting product development projects and see your impact on products that matter.
- Comprehensive benefits package.
What's Next
Apply now by clicking the “Apply Now” button or reach out to us directly for more information. If this role isn’t quite right, but you are seeking something similar within medical device engineering, please get in touch—we have multiple opportunities available.
