Manufacturing Engineer
2 weeks ago
Resonetics is a leading global provider of advanced engineering, prototyping, product development, and micro-manufacturing services, driving innovation in the medical device industry. With a strong focus on operational excellence and continuous improvement, Resonetics fosters a dynamic and employee-centered culture that encourages collaboration and innovation.
The company is seeking a skilled Manufacturing Engineer to lead innovation and process optimization in its life science manufacturing operations. This role will focus on developing and refining manufacturing technologies, including Nitinol processing, laser cutting, shape setting, electropolishing, and dimensional inspection using CMM equipment, as well as serving as a technical bridge between Quality, Production, and Process Development teams.
Key responsibilities include optimizing manufacturing processes, improving production yields, and reducing cycle times. The successful candidate will also be responsible for enhancing process stability, leading troubleshooting efforts for complex manufacturing challenges, establishing robust process controls, and training production personnel on best practices.
Additionally, the candidate will be responsible for generating and maintaining detailed work instructions, ensuring production readiness for new projects, and driving continuous improvement initiatives across existing processes.
- Sustain Nitinol production lines by resolving NCMRs, CAPAs, deviations, updating Work Instructions (WIs) and PFMEAs, and monitoring daily metrics such as yield and efficiency using SQDCT boards system.
- Ensure the accuracy of ERP standards / routings by conducting time studies and promptly correcting any variances between actual operator performance and ERP standards to maintain accurate efficiency metrics.
- Regularly update product cost using cost sheets and quote models to drive operations planning and site strategy.
- Utilize root cause analysis tools such as DMAIC or A3 to lead investigations into customer complaints, process yield improvements, and defect reduction.
- Execute equipment qualifications (IQs, OQs), Test Method Validations (TMVs), and process validations (PQs) for new product introductions or transfers, ensuring a smooth transition from Process Development to Production.
- Track and manage assigned CAPEX projects and expenses, ensuring alignment with site objectives and cost-efficiency.
- Lead assigned Continuous Improvement Projects (CIP) for existing manufacturing lines to drive cost savings through yield improvements, enhanced operational efficiency, labor optimization, material savings, and more, while providing regular project updates to the staff team.
- Support troubleshooting of production equipment (Lasers, welders, furnaces, EP benches, OGPs, etc.) during downtime events to minimize disruption and ensure swift recovery of manufacturing lines.
- Ensure compliance with QMS and ISO 13485 standards in all production, validation, and project execution activities.
- Minimum of 3 years of experience in a Manufacturing Engineering role, preferably within the medical device industry or a regulated environment.
- BS degree in Mechanical Engineering, Industrial Engineering, or a related technical discipline, or equivalent hands-on experience in a manufacturing environment.
- Strong technical writing and communication skills, with the ability to create and update detailed process documentation such as validation protocols and reports.
- Experience with Lean manufacturing methodologies, including line balancing, waste elimination, Kaizen, root cause analysis (Ishikawa), and other continuous improvement tools.
- In-depth knowledge of Quality System Regulations (QSR), risk assessment tools (PFMEA), and ISO 13485, ensuring compliance throughout manufacturing and validation activities.
- Certification or practical experience with Six Sigma methodologies, with proficiency in statistical tools such as Design of Experiments (DOE), regression analysis, and hypothesis testing.
- Hands-on experience with laser systems or similar precision manufacturing equipment.
- Experience with Nitinol processing, including laser cutting, shape setting, and electropolishing.
- Proficiency in data analysis and visualization tools such as Power BI.
- Experience in the medical device industry, with a strong understanding of industry-specific regulatory requirements.
- SolidWorks or CAD experience, ability to design fixtures.
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