Manufacturing Engineer

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New Product Introduction Regular Full-Time Professional Bethlehem, PA, US

Position Summary:

The Manufacturing Engineer applies advanced engineering principles, technical expertise, independent judgment, and analytical problem-solving to design, develop, validate, and continuously improve manufacturing processes for precision medical-device components. The position independently evaluates manufacturing requirements, develops technical solutions, leads process improvement and validation activities, and provides engineering guidance supporting product quality, manufacturability, cost, and operational performance.

Essential Duties and Responsibilities
:

• Act as project manager and customer point of contact for projects and technical engineering information, ensuring customer satisfaction.
• Develop and implement – PFP’s, PFMEA’s & Control plans as needed.
• Perform reviews of customer orders and determine processing requirements to produce cost effective conforming components and assemblies.
• Develop manufacturing processes and routers that are consistent with customer (Quality agreement) and BMI operating procedures and work instructions through analysis of application, research, design, modification, and testing of manufacturing methods and equipment.
• Develop machine and secondary process validations and follow through to ensure completion of validations.
• Develop testing protocols working with R&D and the engineering team.
• Evaluate and improve manufacturing processes to support customer and BMI requirements by working closely with production; designing and conducting research; applying knowledge of product design, fabrication, assembly, tooling and materials.
• Use lean tools and principles to reduce various forms of waste in manufacturing processes to reduce product cost and lead time, while maintaining or improving quality.
• Develop prints, create BOMs and routings within the ERP system as needed.
• Review prints for proper instrument function, manufacturability and inspection.
• Participate to vendors’ evaluation and engineering management of them.
• Assist ME’s, QE’s with a range of machine and process validation activities as needed (IQ,OQ,PQ).
• Participate in design review with RD team and customers, validation process and continuous improvement activities.
• Participate at vendors’ audits with quality, to insure all BMI requirements are fully understood and applied.
• Manage the manufacturing processes for new orders from concept to production. Guarantor of processes within the company.
• Create a part number data base to reflect whether product is manufactured in-house or outside.
• Analyze manufacturing performance through time studies and other engineering methods and independently identify, develop, and implement continuous-improvement opportunities.
• Partner with the programming department to develop/design custom tooling that would be required for machining, or purchase tooling as required.
• Review subcontractor processes for efficiency and challenge the process when needed; participate in audits as needed.
• Provide engineering analysis and technical input to support quoting, including evaluation of manufacturing methods, process requirements, tooling, equipment, and technical feasibility.
• Process owner to improve Epicor utilization for the manufacturing engineers.
• Assist with material review board when there is non-conformance product.
• Identify and justify new equipment reflective of process improvements.
• Lead and support the CAPA and Complaint processes to ensure timely closure, for engineering, subcontracting or manufacturing subjects.
• Facilitate…