Director of Manufacturing Engineering

About Company

Mizuho OSI is the leader in the markets for specialty surgery and patient positioning. The company’s portfolio includes specialty surgical tables for procedure-specific approaches that improve patient outcomes in spine and orthopedic surgeries along with disposable and reusable surgical patient care products.

Job Summary

The Director of Manufacturing Engineering develops and implements short- and long-term strategies in support of company objectives. Scope of responsibility covers new product transfer to Operations from R&D, sustaining activities in partnership with R&D for all active products and the development of new competencies, capabilities, and technologies appropriate to manufacturing operations. The Directoroversees staff who are responsible for planning, developing, implementing, and installing production equipment, processes, tools and methods required to transfer new products to manufacturing, and to sustain the manufacturing of released products. The Director is responsible for budgeting, staffing of the manufacturing engineering department, and for establishing systems, programs, policies and procedures that ensure ISO 13485 compliance is maintained.

Responsibilities

• Lead, train and mentor staff, as appropriate, to ensure compliance to regulatory requirements.
• Motivate a team of engineers to achieve aggressive targets on project deliverables
• Take the lead role regarding manufacturing transfer. Work cooperatively with the Marketing, Quality, Operations, Purchasing and R&D New Product Engineering teams to prepare for the transfer of new products to production.
• Partner with R&D Engineering during product development to ensure the strong consideration of DFx (Design For Manufacturing/Assembly/Service) and supplier cost/quality/capability.
• Practice and train team members on Lean Manufacturing tools (process mapping, demand flow technology, product Poka Yoke, etc.)
• As a senior member of the Operations staff help create and deploy creative strategies that advance the capability of the Operations team.
• Collaborate with other Mizuho engineers on electro-mechanical designs, and activities concerned with technical developments, scheduling, and resolving engineering design and test problems within standard regulations.
• Work directly with Operations/Assembly to successfully launch new products, giving consideration to training, facility layout, utility requirements, effective workflow and capacity planning.
• Lead the manufacturing risk assessment effort and direct the creation and update of Process Failure Modes Effects and Analysis (PFMEA).
• Specify the methods, sequence and description of operations, shop routing, time standards for each operation, and the specification for required tools and fixtures., along with the verification and/or validation test documentation.
• Develop, update and maintain manufacturing and test documentation that ensures consistent assembly and testing of products.
• Participate in MRB activities to disposition rejected materials and mitigate future non-compliant issues.
• Support manufacturing and assembly activities by resolving ad hoc problems, developing appropriate tooling and fixturing to improve product consistency, and quality.
• Work cooperatively with Purchasing and Quality to assess suppliers’ and subcontractors’ capabilities, and to resolve technical issues regarding received components, materials and services.
• Pursue cost improvements on existing products through rigorous analyses of processes, procedures, materials and design.
• To 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.
• To 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

• Bachelor’s degree in electrical engineering, mechanical engineering, or related field. A minimum of ten (10) years of manufacturing engineering experience with at least four (4) years in a management capacity or equivalent combination of education and experience.
• Strong technical background with thorough knowledge of manufacturing processes and materials in a medical device environment preferred.
• Excellent creative, innovative and results oriented project management skills.
• Strong use of Microsoft Office (e.g., Excel, MS project, Word). Familiar with a 3D solid modeling package, preferably Solid Edge, Solid Works, and AutoCad software.
• Proven hands-on experience with QSR/ISO 13485 medical device requirements preferred.
• Ability to lead, motivate and develop staff.
• Goal driven independent thinker, equally capable as an individual contributor or team leader.
• Excellent written and verbal communication and interpersonal skills.
• Expertise in Lean Manufacturing methods.
• 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 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.
• Respond sensitively to the needs and feelings of others regardless of position; to accept interpersonal differences, to maintain rapport, and to interact effectively with all levels of employees within the organization.
• Able to demonstrate an understanding, and the regular use of a time management process, which systematically structures one’s own work to provide for effective task performance and to plan and prioritize items to meet future demands.
• Ability to establish and accomplish goals independently and to function as a positive and productive team member.
  
  

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Salary: $161,810.60 - $231,158.00 Plus Bonus