We are seeking a motivated and proactive Senior Manufacturing Engineer to join our core Engineering team within the medical device manufacturing industry. Reporting to the Engineering Manager, this role plays a key part in driving process improvements, supporting production operations, and delivering high-quality, compliant manufacturing solutions. The ideal candidate will thrive on solving complex problems, identifying opportunities for efficiency, and contributing to a culture of continuous improvement.
Key Responsibilities
- Collaborate with cross-functional teams and operational leaders to cultivate a continuous improvement culture, driving sustainable change and operational excellence.
- Enhance process performance by simplifying complex procedures, identifying waste, and optimizing existing manufacturing systems.
- Lead root cause analyses and implement robust, long-term technical or system solutions to address quality and process challenges.
- Develop and maintain preventive maintenance procedures for critical manufacturing equipment.
- Research and assess emerging process technologies to determine potential benefits and competitive advantages for implementation.
- Ensure that all products and processes meet stringent medical device quality and compliance standards.
- Resolve technical and quality issues efficiently to minimize impact on production and customer delivery.
- Work closely with the Production Support team to introduce process improvements, equipment upgrades, and product enhancements.
- Prepare and update manufacturing documentation and process specifications following established change control protocols.
- Ensure compliance with Health, Safety, and Environmental standards at all times.
- Identify, lead, and execute continuous improvement projects aimed at reducing waste, improving yield, and increasing efficiency.
- Support new equipment qualification and validation activities (EIQ/EOQ, DOE, OQ/PQ).
Key Skills & Experience
- Previous experience in medical device manufacturing is highly advantageous.
- Strong background in process troubleshooting and problem-solving methodologies.
- Proven ability to design, validate, and implement new manufacturing processes and equipment, working closely with suppliers or vendors.
- Capable of managing multiple projects simultaneously with effective planning and prioritization.
- Experience in jig and fixture design or maintenance is a plus.
- Working knowledge of Lean Manufacturing principles and statistical analysis tools.
- Familiarity with Minitab, SolidWorks, or AutoCAD software is desirable.
- Excellent interpersonal, communication, and organizational skills with a results-oriented mindset.
- Understanding of ISO and FDA regulatory compliance requirements for medical device manufacturing.
Qualifications
- Bachelor's Degree in Engineering or a related discipline.
- Minimum of 3+ years of relevant experience in a manufacturing or engineering environment, preferably within the medical device sector.
