A medical device manufacturing organization is seeking an experienced Manufacturing Engineer for a contract to hire engagement. This role will be responsible for developing, maintaining, and implementing robust, cost-effective manufacturing processes and methods in accordance with customer product specifications and applicable medical device quality standards.
The Manufacturing Engineer will support both existing production and new product introduction, with a focus on continuous improvement, process optimization, tooling and fixturing, quality, cost reduction, and operational efficiency.
Key Responsibilities
- Plan, implement, and execute continuous improvement initiatives focused on cost reduction, quality enhancement, productivity, and manufacturing efficiency.
- Develop and improve manufacturing work instructions, product flow, assembly methods, space utilization, product quality, and safety performance.
- Support the manufacturing launch of new products, including evaluation of yield targets, production run rates, training requirements, and quality results.
- Prepare engineering change documentation and coordinate implementation of process or product changes, including training for production personnel.
- Conduct product and process analysis to identify opportunities for cost reduction, quality improvement, and increased efficiency.
- Utilize risk management methodologies, including PFMEA and hazard analysis, to identify manufacturing risks and develop appropriate corrective actions.
- Support equipment installation qualifications, process validations, and legacy equipment/process qualification activities.
- Troubleshoot manufacturing processes when defects or production issues occur; assist with root-cause analysis and implement effective containment and corrective actions.
- Participate in material review activities and support investigations involving non-conforming materials, products, or customer complaints.
- Develop, test, and provide cost/ROI justification for manufacturing tools, fixtures, equipment, and process improvements.
- Develop disposition and rework procedures for non-conforming products.
- Communicate with customers and internal stakeholders regarding process improvements and requested production changes.
- Represent Manufacturing Engineering on cross-functional project teams.
- Participate in Kaizen events and lead continuous improvement initiatives using Lean Manufacturing principles.
- Schedule, facilitate, and lead project meetings related to current and future manufacturing process initiatives.