Designs, develops and manages projects in the area of new product development with a focus on customer driven new innovation products and line extensions. Coordinates with all departments, vendors and customers to ensure smooth development, release and production startup for line for new products. Provides engineering support for existing products and continuation engineering initiatives. Provides technical, project management and process improvement leadership within the engineering group.
Essential Duties and Responsibilities include the following. (Other duties may be assigned.)
Plans and manages multiple intermediate product development and/or continuation engineering projects simultaneously.
Responsible for creating schedules and milestones based on customer and company needs.
Communicates with Original Equipment Manufacturer (OEM)customers on product specifications and other technical matters at a project or program level.
Develops cost and resource estimates for projects and products.
Able to work collaboratively with designers on technical matters related to product design.
Provides proactive inter/intradepartmental communication and information relating to project or process status.
Designs, develops and maintains products within and outside of existing product lines.
Shows introductory knowledge of CAD system(s).
Responsible for generation and approval of product development documentation, including product specifications, on assigned projects.
Able to make decisions on intermediate technical matters related to product design. Investigates new materials as well as new manufacturing techniques.
Generates quality systems and project related documentation as needed. (i.e. DHF documents, work orders, charters).
Understands and follows engineering related and overall company processes.
Experience with following processes of ISO 9001.
Preferred experience with ISO 13485, ISO 14971, FDA and MHLW requirements.
Attends all relevant training.
Keeps abreast of relevant developments in technology.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Other Skills and Abilities
Demonstrates design, documentation, materials management, design for manufacturing, process management and troubleshooting/problem solving skills.
Demonstrates interpersonal, organizational and time management skills.
Demonstrates good communication skills and attention to detail.
Experience with Microsoft Excel for spreadsheets, Microsoft Project for scheduling and resource planning, Microsoft Word for word processing and Computer-Aided Design (CAD) tools (including 3D modeling).
Experience with manufacturing processes including injection molding, machining, and mechanical assembly.
Prefer related medical device development experience.
Regular, predictable attendance is required for the ability complete all work.
Requires face-to-face interaction with team members, peers and management to complete work and provide support.
May be required to occasionally travel between Coralville headquarters and the Kalona manufacturing facility.
Education and/or Experience
Minimum of a Bachelor's degree (BS) in engineering from a four-year college or university; and three to eight years related experience and/or training; or equivalent combination of education and experience.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to sit; reach with hands and arms and talk or hear. The employee is frequently required to use hands to finger, handle, or feel. The employee is occasionally required to stand; walk; climb or balance and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, color vision, depth perception and ability to adjust focus.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is frequently exposed to moving mechanical parts. The employee is occasionally exposed to toxic or caustic chemicals and risk of electrical shock. The noise level in the work environment is usually moderate.
Civco Medical Solutions