Must haves on the resume:
- Must be proficient with SolidWorks, Oscilloscope and Engineering Change Orders.
- Must be familiar with ERP SAP system, Agile or the like and Electro-Mechanical assemblies – PCBAs & Sheetmetal experience and have troubleshooting experience with instrumentation devices.
- Must have Medical/Pharmaceutical industry experience.
- The Senior Manufacturing Engineer (ME) will be expected to simultaneously lead multiple high impact projects.
- The ME is expected to lead change, contribute new ideas, and find innovative methods to accomplish goals.
- Works on complex mechanical/electrical/electronic problems where analysis of situations or data requires an in-depth evaluation of various factors.
- Acts independently, and exercises judgment within broadly defined practices and policies.
- May supervise the activities of others.
- Determines methods and procedures on new assignments.
- The ME will be expected to have the ability to get things done through people that do not report to them.
- The ME will also need to have the ability to work through adverse situations while building and maintaining good personal relationships.
- Initiate, plan and author engineering change orders to product design, product documentation, Bills of Materials, manufacturing/test/packaging procedures, process routings, tooling, compliance (EMC, safety, laser safety, ROHS, UDI etc.), suppliers and other items in a controlled manufacturing environment.
- Follow proper document formats, material and description nomenclature, and correct SAP data types per company standards.
- Coordinate with various functions for change review and impact analysis, ensuring cross-functional requirements are identified and understood for affected items, personnel, and processes.
- Lead cross functional project teams to optimize product design, qualify replacement components, improve manufacturing operational efficiency, product quality, customer satisfaction, and reduce manufacturing costs.
- Capable of solving and determining root cause of difficult technical issues encountered during assembly and test of production assemblies. Must be able to implement effective solutions in a timely manner to resolve mechanical, optical, electrical, and fluidic issues.
- Support the introduction and transfer of new products into manufacturing. Review engineering designs and documentation (drawings & specifications) for completeness, clarity, and manufacturability.
- Evaluate and qualify new suppliers. Interface with Product Development to define and implement manufacturability criteria, develop procedures/processes for assembly, PCB’s, systems, and sub-systems test procedures including fixtures, during the development process. Ensure designs, documents, and procedures have been validated in manufacturing prior to production release.
- Conduct field failure investigations, identify root causes, and participate in corrective and preventative action efforts.
- Keep abreast of the basic requirements for compliance. Participate as required in training on regulatory issues affecting own area of work. Bring regulatory compliance questions/issues to the attention of management.
- Performs other related duties and assignments as required.
- BS degree: ME, EE, IE, Physics, or equivalents.
- At least 4 years of experience in a high-tech manufacturing environment.
- Experience sustaining and troubleshooting electro-mechanical devices/equipment.
- Must be proficient in the use of personal computers: SolidWorks (CAD), MS office (Word, Excel, Power Point, Project, Visio), Adobe.
- Familiar with Enterprise Resource Planning (ERP) SAP, Agile or the like.
- Excellent written and verbal communication skills, must have good interpersonal skills: conflict resolution, negotiation, and time management skills.
- Must be able to understand engineering drawings, Bills of Materials, and operational procedures.
- Must have extensive experience writing and reviewing Engineering Change Orders.
- Must have strong project management experience, Led continuous improvement efforts with cross functional teams.
- Experience developing manufacturing processes, writing procedures, and training assembly personnel.
- The ability to assess and resolve multiple high visibility problems in a timely manner.
- The ability to successfully interact with executive management.
- Ability to be effective with minimal direction. Recognizes problems and addresses them without waiting to be instructed to do so.
- Familiarity with ISO 9001 and 13485 standards.
- Willingness to travel when required.
Preferred Skills and Qualifications:
- M.S. degree.
- Proficiency with some of the following applications: Pro-E, AutoCAD.
- Experience resolving technical issues involving lasers and optical components.
- Broad experience supporting many of the following commodities or supplier types: lasers, optical components, fluidic systems, machined parts, sheet metal, cables, PCA’s, plastics, power systems, product packaging, turnkey subcontractors, hardware, labeling.
- Strong cGMP familiarity 21 CFR part 820, medical industry experience.
- Experience implementing Demand Flow Technology (DFT) processes.
- Experience implementing LEAN manufacturing processes.
- 6 Sigma green or black belt.