Essential Duties and Responsibilities
The Advanced Manufacturing Engineer is a critical member of the cross-functional team that works with the Product Development Engineers in the early stages of product launches to assure design for manufacturability (DFM) and design for automation (DFA). The Advanced Manufacturing Engineer is responsible for understanding the key design and process inputs and defines the “should-be” process based on these inputs. Once defined, the Advanced Manufacturing Engineer identifies the process requirements and implements the equipment identified solution. The Advanced Manufacturing Engineer is also responsible for continuous improvement of existing production cells, through implementation of industry best practices and automation.
Additional Duties and Responsibilities
- Work with New Product Development (NPD) design engineers and cross-functional teams to evaluate and advise product design for optimized manufacturability.
- Work closely with other functional areas including Regulatory, Trade Compliance, R&D, Sourcing and Quality to drive successful project implementation.
- Actively engages with Process Engineers and Operations to evaluate existing process layouts in terms of new process integration, ensuring best utilization of floor space, minimized handling and optimum process flow.
- Execute validation and qualification (IQ/OQ/PQ) protocols for new product, equipment, tooling, and processes. Follow SOP on re-validation of existing equipment, tooling, and processes.
- Provides on-going status reports including periodic reviews progress and evaluation of results to management.
- Complete validation documentation for new product launches, including: PFMEA’s, Capability studies, Process Verification reports, Work Instructions, and Control Plans.
- Identify root-cause of failures through experimentation (DOE’s) and historical data analysis.
- Define the process for new product launches, including required equipment, process monitoring, and data collection.
- Justify proposed solutions based on data from cycle-time studies, current labor costs, and capital investment required.
- Create Request for Quotation/Proposal (RFQ/RFPs) that documents the design requirements of the automated equipment, delivery schedule, required documentation and qualification for acceptance at machine supplier facility and contract manufacturer’s factory.
- Engage machine suppliers for automated equipment design reviews and proposals.
- Travel to the machine supplier and contract manufacturer for equipment bring-up, qualification, acceptance testing and support during build events
- Provide direction and mentorship to third party machine/automation suppliers and/or CM’s; be the technical leader and driver on owned projects; serve as a technical resource to other engineering groups and project leaders.
- Training of direct labor in newly developed or improved processes to ensure smooth transition to production.
- Complete projects and report status in a timely manner. Utilize project management tools in establishing timelines, building action item list, and completing milestones. Provide on-going status reports including periodic reviews progress and evaluation of results to management.
- Maintain hazardous waste according to EH&S procedures.
- Other duties as assigned.
This job has no supervisory responsibilities.
Requirements (Education, Certificates, Licenses, Registrations, etc.)
- Bachelor of Science in an Engineering discipline (Mechanical, Bio Medical or Chemical Engineering preferred) from an accredited university with a minimum of 8 years of experience in a manufacturing environment.
- Experience in an FDA regulated manufacturing environment (preferably Medical Device) or other regulated industry is preferred.
- Experience with R&D, new product development or new process design.
- Demonstrated program or project management skills.
- Experience with root cause analysis.
- Six Sigma Green or Black Belt preferred.
- Lean Manufacturing Experience preferred.
- Excellent written and verbal communication and effective human interaction skills.
- Flexible to change and possess a high degree level of integrity and “can do attitude”.
- Willing to work in a team environment and contribute to group goals
- Ability to receive and provide instructions in a positive manner.