What are the responsibilities and job description for the Product Engineer position at Current Opportunities?
Duties & Responsibilities:
- Manage product development projects within a defined Product Development System, beginning with Voice of the Customer concepts through successful steady-state production implementation; directly provide necessary engineering contributions for project success
- Coordinate and manage new product introduction schedules and cross-functional activities throughout the development process. Manage cross-product issues throughout the product life cycle. Lead quality improvement efforts as required
- Create and manage BOMs and routings for new products
- Conduct all appropriate risk management activities related to the design and development of medical devices in compliance with FDA/CE/Health Canada/etc. requirements
- Create and manage engineering documentation (including 3-D models, 2-D drawings, Engineering Specifications, and manufacturing procedures) necessary for the proper manufacturing of products
- Define and develop test protocols to evaluate product features and functionality
- Define and develop manufacturing processes related to new products; work with process engineers to integrate new products into existing processes
- Provide technical support and assist in the resolution of manufacturing problems as required
- Provide technical resolution of customer complaints relative to assigned product lines
- Communicate the status of projects to all levels within the organization
- Pursue and support cost reduction activities to achieve established company goals
- Review, process, and approve Engineering change orders applicable to product line responsibilities
- Maintain a general awareness of and explore promising new materials and methods applicable to orthodontic products
- Develop a deep understanding of manufacturing process capabilities, giving them full consideration during design and development activities
- Perform additional responsibilities as requested to achieve business objectives
Qualifications:
- BS in Mechanical or Biomedical Engineering or equivalent required
- 3 - 5 years’ experience in product engineering Experience with managing product development projects desired
- Experience with SolidWorks or equivalent CAD software and MS Office
- Strong ability to communicate both verbally and in writing is required
- Experience managing projects desired
- Understanding of FEA techniques, DFM, FMEA, DOE, SPC, QFD, and industrial statistics
- Demonstrated data-driven problem-solving ability required
- Basic understanding of regulatory requirements for medical device design control and manufacturing strongly desired
- Knowledge of Lean Concepts and Six Sigma desired
- Experience with manufacturing process control desired