Position Summary:

Senior Manufacturing Engineer (Instrumentation Laboratory Company, a Werfen Company, Bedford, Massachusetts): On behalf of a worldwide developer, manufacturer, and distributor of specialized diagnostic instruments for hemostasis, acute care, and autoimmunity products and services, is responsible for leading the process engineering and production support of a product or product line. Will provide technical leadership and support for continuous improvement team efforts focused on process improvement and optimization. Will provide engineering leadership for the design, documentation and implementation of assembly methods, test methods, equipment operation, including specification and optimization.

Specific responsibilities will include:

• Resolve production process issues utilizing problem solving techniques to analyze, identify root cause(s), and development and implement solutions.
• Serve as a Product Champion for a specific product or product line with the following leadership responsibilities:
  • Serve as the focal point in operations for the products which they have responsibility for.
  • Lead the resolution of production process issues utilizing problem solving techniques to analyze, identify root cause(s), and develop and implement solutions.
  • Lead the process engineering and production support activities required for the manufacture of a product line.
  • Provide technical support and leadership for continuous improvement team efforts focused on process improvement and improvements to product manufacturability.
  • Provide technical leadership and hands-on engineering support, including specification and implementation of assembly and test methods and process optimization.
• Provide technical support for continuous improvement efforts conducting root cause analysis then formulating and implementing corrective action proposals.
• Establish the Manufacturing Quality Plan (MQP) for a product or product line including process flow, production floor layout, equipment, and line balancing.
• Write process procedures, change orders, equipment specifications, validation plans, and reports.
• Perform research on technology, equipment and tooling to improve process quality, yield, and/or cost.
• Generate proposals for purchase and implementation, including cost of ownership, return on investment (ROI), and benefit analysis.
• Perform engineering design of test equipment, assembly equipment, fixtures and tools.
• Perform IQ/OQ/PQ validation activities.
• Participate in the introduction of new products into manufacturing. Collaborate with R&D and suppliers to improve product robustness and manufacturability both pre- and post-release.
• Supervise personnel in classifications below that of a Senior Manufacturing Engineer.
• Participate in Lean Six Sigma projects of significant scope and complexity.

Position requires less than 10% of time on domestic travel.

Minimum requirements: Master’s degree in Manufacturing Engineering, Manufacturing & Mechanical Systems Integration, or a closely related technical field and 4 years of experience as a Manufacturing Process Engineer or related technical role performing technical support for the manufacturing of capital equipment or product in a regulated environment. 

Must also have: (I) During experience required above, must have had exposure to: (a) New Product Introduction (NPI) including process; (b) Fixed product routing in the factory to avoid unnecessary move times; (c) Establishing a Kanban system for production; and (d) Executing process improvement and defect reduction projects by means of fixture design and processing changes; (II) Advanced technical and engineering skills in analyzing information, reviewing technical reports, promoting process improvement, requirements, development, risk management, product development, and product controls; (III) Background: (a) Performing quality assurance in the medical device or IVD industry; (b) Performing IQ/OQ/PQ in a regulated environment; (c) Researching and developing new process methodologies including introducing equipment or tools to be used in production; (d) Working closely with Design Engineers and New Product Introduction (NPI) team on projects to successfully transition from design conception to production; and (e) Supporting Design for Manufacturability (DFM), prototyping, Device History Records (DHR), and documentation for assembly and test work instructions, visual aids, and Bill of Materials (BOM); (IV)Track record creating work instructions and visual aids to train operators on new processes and products implemented via Engineering Change Orders, Engineering Notices, and Corrective Action Plans; and (V) LEAN/Six Sigma Certification and background in Lean/Six Sigma problem solving methodologies.

Apply by resume only to lortega@werfen.com including VP10042 in subject line.

The annual salary range Werfen reasonably expects to pay for the position is $134,202- $149,202.  Compensation is reasonably based upon multiple factors including education, relevant experience, skillset, knowledge, and specific needs of the business.