The Manufacturing Engineer II position supports, improves, implements and sustains optimal, cost-effective and compliant manufacturing processes in accordance with product specifications and quality standards; recommends and implements improvements to production processes, methods and controls; coordinates manufacturing launch for new or revised products. Works with suppliers to ensure seamless transactions and proper understanding of requirements. This position will be focused on manufacturing engineering support of multiple product lines.
- Carries out process improvement, root cause problem solving, project management and employee training.
- Awareness of DFM and manufacturing robustness of process parameters for critical processes and repeatability
- Applies engineering principles in managing, supporting, and maintaining the production of new and existing products and implementation of design changes and product improvements
- Performs independently on most assignments with instructions as to the general results expected. Documents work and reviews proves and results with manager.
- Generates engineering documentation (specifications, risk analysis, drawings, reports, protocols, revisions, etc.)
- Improves manufacturing processes and methods for quality improvements, efficiency and capability improvements.
- Prepares and presents detailed plans necessary to complete assigned projects. Develops schedule milestones, coordinates manpower, facility and equipment for assigned projects
- Assists in improving the system of production controls, standard operating procedures, safety, quality control and training.
- Performs development of manufacturing processes including production flow, assembly methods and production equipment.
- Prepares and maintains detailed layouts of buildings and equipment.
- Coordinates the manufacturing launch of new/revised products including establishing goals, training team members and evaluating results.
- Designs, develops and tests as well as sources various tools, machinery and equipment for recommended manufacturing methods while providing ROI analysis.
- Performs product/process analysis for production and quality metrics.
- Represents manufacturing on cross-functional teams.
- Write engineering change orders to process changes to manufacturing documents, drawing, Bill of Materials
- Support company finance, accounting, human resources, quality, regulatory, and clinical departments as necessary to ensure compliance with requirements.
Education, Experience and Other Skills
- Bachelor’s degree in engineering or related field
- 3 + years of Manufacturing/Sustaining experience
- Strong oral and written communication skills; customer focused
- Experience with programs including SolidWorks and/or Mastercam
- MS Office Proficiency
- Problem-solving skills to identify, gather, and analyze information develop solutions and resolve problems in a timely manner
- Working knowledge and experience with Quality System regulations and guidelines ISO, FDA, and GMP
Mental and Physical Requirements
- Ability to handle and be trusted with confidential and/or sensitive information.
- Ability to work in a fast-paced, constantly changing environment.
- Ability to be flexible and to handle multiple projects in an organized, timely manner.
- Ability to problem-solve, work under pressure, and to effectively manage stress.
- Ability to work overtime as needed.
Authority and Responsibility
- Accountable for their performance and will have authority as delegated to complete their tasks and objectives.
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