Senior Manufacturing Engineer

Senior Manufacturing Engineer

The Senior Manufacturing Engineer designs, develops, implements and maintains manufacturing processes for new products, product changes, and enhancements. Facilitates the supply, manufacture, assembly, and test activities with cost reduction and waste elimination as the key drivers. Contributes to the intellectual property position of the company via invention and patent application. Works with the product development staff to ensure the manufacturability of new products and achieve cost targets by improving efficiency through the implementation of lean manufacturing methods. Provides support for the resolution of product complaints and/or safety issues.

Responsibilities:

• Maintain a continuing liaison relationship with R&D engineering, marketing, assembly, and quality functions to ensure readiness to meet commitments of new business and to ensure that production rates and product designs provide effective utilization of available manufacturing resources.
• Take ownership of new products during pilot production phase through successful and sustained project launch. This includes but is not limited to driving new product introduction schedules, escalating and resolving manufacturability issues.
• Design, qualify, document and introduce production and service assembly/test fixtures and equipment.
• Configure assembly processes, sequence of activities, and material handling toward lean manufacturing practices, supporting company goals.
• Plan and schedule projects in a manner consistent with corporate objectives.
• Identify and qualify outside vendors and consultants, as required.
• Maintain current knowledge of competitive technologies including medical, technical, manufacturing and material developments as related to company products.
• Conduct testing, utilizing new or existing test protocols, to ensure process capability.
• Maintain complete, accurate and timely manufacturing documentation including assembly, procedures, testing methods, packaging and labeling instructions, BOM, and others as required.
• Develop test plans and procedures dealing with material acquisition and substitution problems, as well as technical issues impacting shipments.
• Oversee the detailed manufacturing planning for each part and assembly.
• Specify BOM structure, methods, sequence of operations, shop routing, time standards, and tooling as required.
• Continually reduce product cost through design, process, procedure, and improve efficiency through the implementation of lean manufacturing methods.
• Optimize manufacturing costs, determine time standards, and make recommendations for tooling and process requirements of new or existing product lines.
• Work with production managers and engineers to support product enhancements from concept through the manufacturing process and finished product.
• Participate in material review board activities to analyze and disposition non-conforming materials and assemblies.
• Lead or participate in assigned initiatives focused on material cost reduction, capacity enhancement, outsourcing of assemblies, etc.
• Ensure product development plan is complete and properly implemented, ensuring manufacturing resources are properly directed during the entire product life cycle.
• Provide sustaining engineering support to production.
• Provide training and support to production staff such as Assemblers, Quality Control Inspectors, Leads, and Supervisors.
• Perform failure analysis and implement corrective action to improve production and quality.
• Recommend and report on production process improvements including efficiency, cycle time, downtime, first pass yield, resource utilization, ergonomic and other continuous improvement efforts.
• Participate in company safety committee and environmental programs as required.
• Domestic travel, as needed, to support supplier audits and other business needs, as necessary.
• Train and instruct other members of the department and the company, by passing along skills and information to assist them in their development and advancement either with one-on-one or with platform training skills.
• Be an independent employee able to analyze problems and formulate plans to overcome challenges and to get work done quickly with a high degree of quality.
• To make sound and logical decisions and to choose the appropriate courses of action based on the parameters of the situation at hand and to use continual improvement problem solving skills.
• Assist in the creation of an ongoing effort to improve the Company and the Manufacturing Department through personal action and by contributing ideas to support both the Department and Company's ongoing improvement efforts.
• Understand Mizuho OSI's business objectives and the relationship between the Department and those objectives; to support and follow the Corporate Vision, Mission & Values Statements, to maintain the services and quality levels set by Mizuho OSI, and to continually enable Mizuho OSI to be a great place to work.
• Understand, follow and support Mizuho OSI's internal Quality System policies, procedures and work instructions including but not limited to applicable external regulations (21 Code of Federal Regulations Part 820 Quality System Regulations and applicable International Standards).

Qualifications & Requirements:

• Master's Degree in Mechanical Engineering & 3 + years of experience in design with emphasis on product design or PhD degree and at least 1 YOE.
• Thorough knowledge of manufacturing processes and materials.
• Demonstrated Electromechanical and/or Process Engineering capability
• Strong technical skills in prototyping and troubleshooting from engineering documentation
• Successful working knowledge and experience writing protocols, running tests, and documenting results.
• Familiar with a 3D solid modeling package, preferably Solid Works, Solid Edge, and AutoCad software.
• Ability to travel to vendor sites as required by management.
• Excellent computer skills including operating Windows based personal computers, various office equipment and machines, and telephone system.
• Ability to efficiently and effectively use Microsoft products such as Outlook, Word, Excel, and PowerPoint.
• Ability to clearly express oneself verbally in the English language (additional languages also preferred) using good grammar, vocabulary, eye contact, and friendly voice inflection with all employees.
• Ability to communicate effectively with employees and other business contacts in a courteous and professional manner.
• Excellent verbal communication skills that enable strong presentation, project, and organizational skills.
• Ability to work independently and, at higher Levels, lead cross functional teams working on specific engineering projects.
• Ability to drive and influence cross functional teams working on manufacturability and new product release projects relative to cost reduction, product redesign, and manufacturing quality.
• Excellent internal and external customer focus with a high sense of urgency.
• Ability to interface effectively across the organization as well as outside the company.
• Ability to function calmly in a fast-paced environment managing multiple priorities simultaneously.
• To be able to positively manage situations of a dynamic nature; to be able to modify plans, actions, and decisions in light of changing situations and circumstances while still meeting, or proposing modified, deadlines.
• Ability to clearly and effectively express oneself through written means, to properly use such technical factors as grammar, punctuation, vocabulary, and correct spelling.
• To be able to write clearly in a variety of business formats, including but not limited to procedures, processes, and technical reports.
• Goal driven independent thinker, equally capable as an individual contributor or project team leader; is data driven and promotes willingness to adopt new methods, procedures, and techniques for organizational and cultural change.
• Ability to work with a professional and positive attitude to proactively support and implement the continuous improvement efforts of manufacturing teams to meet the department goals and objectives.
• Knowledge and experience with Lean Manufacturing concepts preferred.
• Experience in medical device manufacturing environment preferred.
• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Pay Scale: $114,000- $140,000 DOE + comprehensive benefits package + potential annual bonus