Soft Goods Engineer

Mizuho OSI•Fremont, CA

25d•$100,000 - $118,000

About The Position

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. The Soft Goods Engineer designs non-sterile and sterile interface products that position, support, and isolate a patient in the operating room. Products may work in conjunction with surgical equipment or stand alone. Some of the products include wearable devices for appendage support, position, and traction, reusable patient position and support pads, single use patient support pads and isolation pad covers, sterile drapes and accessories. Works closely across functions with engineering, manufacturing, marketing, quality, and regulatory staff to develop product specifications and designs. Develops prototype units and production equivalent devices with both in-house and contract manufacturing suppliers. Performs unit and system level analysis and testing to assure product performance, reliability, and safety. Coordinates production release of new products and sustains/improves existing products. Contributes to the intellectual property position of the company via invention and patent application. Identifies and qualifies outside vendors and consultants as required. Maintains current knowledge of competitive technologies including medical, technical, manufacturing, and materials development as related to company products. Maintains complete, accurate, and timely design history documentation, including testing methods. Provides support for the resolution of product complaints and/or safety issues. Participates in review and disposition of non-conforming material and assemblies.

Requirements

Ability to apply engineering principles using logical or scientific thinking to define problems, collect data, establish facts, and draw valid conclusions.
Ability to find creative and innovative solutions for design of human interface soft good products, including related mechanical parts and assemblies. Ability to understand and develop ‘smart products’ implementing electronic sensors, processors, motors, etc.
Knowledge of manufacturing processes for cloth and woven fabrics, foams, plastics, metals, and other materials employed in medical grade soft goods.
Knowledge of sterile goods manufacturing and qualification procedures.
Fluency with a 3D solid modeling package, preferably SolidWorks. Experience w/ a pattern making software tool would be a plus.
Computer skills including operating Windows based personal computers. Ability to efficiently and effectively use Microsoft products such as Outlook, Word, Excel, MS Project, and PowerPoint.
Clearly express oneself in writing and verbally in English Communicate effectively with Team Members and other business contacts in a courteous manner. Verbal and written communication skills to include presentation of project status and technical discussions.
Customer focus with a high sense of urgency. Able to positively manage situations of a dynamic nature; able to modify plans, actions, and decisions in light of changing situations and circumstances while still meeting, or proposing modified deadlines.
Ability to establish and accomplish goals independently and to function within the team as a positive and productive team member.

Responsibilities

Work independently or across functional development teams to fully define user needs and product specifications. Design, develop, analyze and test complex medical soft good prototypes and V&V units that meet these specifications.
Participate with New Product Introduction (NPI) to assure product designs are producible in the Mizuho OSI manufacturing environment that are cost effective for the sales volume expected.
Evaluate clinical field input from Customers, Marketing, and Service or Sales organizations regarding product performance. Where does the input come from the customer, through Sales or Marketing?
Maintain a continuing liaison relationship with Manufacturing and Marketing functions to assure readiness to meet commitments of new business and to assure that production rates and product designs provide effective utilization of available manufacturing resources.
Continually reduce product cost through design, process, procedure, and method improvement.
Collaborate with other engineers across the organization and at our contract manufacturers on soft good, mechanical, and system designs. Contributes with technical developments, scheduling, and resolving engineering design and test problems within required regulations.
Hold internal design reviews as well as lead user reviews, and ensure solutions achieve required quality levels, reliability, and consistency.
Use computer software to create and modify product layouts, and effectively document designs by generating proper drawings.
Participate in vendor selection, sustaining engineering, QC inspection, and material review board activities.
Assist other engineers and designers with technical input as necessary. At a more senior level engineer, may lead projects and provide technical leadership.
Train and instruct other members of the department and the company as appropriate, by passing along skills and information to assist them in their development and advancement either with one-on-one or with platform training skills.
Analyze problems and formulate plans to overcome challenges and to get work done quickly with a high degree of quality. Make sound and logical decisions and choose the appropriate courses of action based on the parameters of the situation at hand and to use continual improvement problem solving skills.
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).
Support R&D and manufacturing for new technology efforts in design and process improvements.