Sr. Manufacturing Engineer

Overview

Position Summary
The Sr. Manufacturing Engineer will develop and implement optimal, cost-effective manufacturing processes and methods in accordance with product specifications and quality standards. This role will also recommend and implement improvements to production processes, methods, and controls and coordinate manufacturing launch for new or revised products. This role will support daily management activities to ensure commitments are achieved and communicated to the customer support teams.

• Develops and implements optimized, highly capable, and cost-effective manufacturing processes and inspection methods (as applicable), in accordance with product specifications and quality standards.
• Develops overall engineering project strategies and timelines, including critical path identification and project risks.
• Recommends and implements improvements to production processes, assembly methods, and controls by utilizing Lean Manufacturing and Six Sigma tools.
• Collaborates with other departments for product tooling, gauging and fixtures design to ensure production methods are robust in support to achieving zero defects, reducing cost of poor quality, and implementing standard work.
• Supports creation of PFMEAs, control plans, process flow documents, contact material documents, and other related manufacturing documentation.
• Estimates resource requirements, production times, and relative costs to provide data for operational decision-making.
• Provides design for manufacturing (DFM) feedback for all products, both new and sustaining.
• Leads justification memos and reports for capital expenditures.
• Participates in the engineering change notice process and contract review process for the engineering team to ensure timely release of engineering changes and customer orders.
• Utilizes Solid Works, NX, or other 3D Modeling software to create and/or modify process drawings.
• Works closely with cross-functional departments to develop, coordinate, and implement technical training for employees.
• Provides engineering support to the production department to troubleshoot and resolve technical problems.
• Leads IQ/OQ/PQ and other process validation activities, including overall strategies and timelines.
• Provides support for CNC programming activities.
• Further develops and refines Engineering departmental standards and best practices.
• Provides basic guidance, mentoring, and training to engineering staff.
• Supports organization and site policies and procedures, goals and objectives, applicable regulations, and good manufacturing practices.
• As applicable, reads, analyzes, and interprets general business periodicals, professional journals, technical procedures, industry standards and governmental regulations.
• Addresses customers’ issues and improves performance, appearance, and impact of product on the end-user.
• Provides support to manufacturing, marketing, and customer service, interfaces with customers and suppliers.
• Applies critical thinking skills to solve practical problems that incorporate a variety of inputs in multi-variable scenarios.
• Performs other duties or special projects as required or as assigned by supervisor.

• Bachelor's degree in engineering (biomedical engineering, mechanical engineering, manufacturing engineering, industrial engineering, material sciences) or an engineering technical field is required.
• 5+ years of experience in similar manufacturing / engineering position or equivalent.
• 3+ years’ experience in CNC machining and/or other manufacturing processes.
• Demonstrated engineering experience in a high precision machine shop and/or assembly environment with moderate to high complexity products.
• Experience and demonstrated proficiency in the use of Mastercam, Solidworks, CREO/ProE or other CAD/CAM software.

• Experience in medical devices manufacturing is highly preferred.
• Knowledge of 3D printing preferred

• Strong interpersonal skills:
  Ability to relate to and work with diverse groups of people. Coordinates project activities and resolves individual conflicts and issues. Handles sensitive and confidential situations and…