The Product Engineer, Healthcare Products division will primarily be responsible for leading the efforts of the division in design, development and commercialization of new product offerings to include developing new designs and assisting operations with scale up of production. They will also be responsible in assisting with the implementation of product enhancements, or holistic modifications to the current offerings of products and solutions aimed at driving top line growth for the Healthcare Products division. Reporting directly to the General Manager of the Division, the Product Engineer will work directly with both the manufacturing and commercial teams to participate in conducting market research, the evaluation of proposed new raw materials, production processes or machinery; as well as new potential suppliers and customers where applicable to collaboratively introduce new products, capabilities, and solutions for the Division.
Essential Duties and Responsibilities
- Prior experience managing team through the design, development and commercialization of medical devices (VOC, SME Feedback, Proto-type Revision Controls), Product development through Stage Gate Process, Product Drawings/Model Creation, Product Specifications, Critical Tolerance Creation, Raw Materials Selection and Testing, Risk Analysis, Production Work Instruction, and Product Testing/QC Criteria, Etc.
- Knowledge of ISO 13485, managing DMR (Device Master Record), DHF (Design History File), and DHR Device History Record), 510K Experience, and cGMP Experience desired.
- Lead team in analyzing alternative products and designs to determine which best meets product specifications; analyzing operational characteristics as needed.
- Work closely with manufacturing to identify and resolve manufacturing issues and to verify capabilities to produce designed products.
- Specify materials for production and assist purchasing with locating and evaluating vendors and their products
- Participate in the research, evaluation and development of new products/markets.
- Set up and conduct prototype testing within the identified product(s) and established Company standards.
- Must have the ability to manage multiple new projects/products at one time.
- Knowledge of cost structures in a manufacturing environment; manage and compile all cost associated with new products/projects and retain records for R & D.
- Research safety standards and compliance initiatives required for a product or new product.
- Assist sales with development of new products or innovating custom products for customers and the writing of specifications, instructions, etc.
- Work with patent attorney in the development of patent applications
- Maintain professional and technical knowledge by attending educational workshops; benchmarking professional standards; reviewing professional publications; and establishing personal networks
- Monitor all internal systems for accuracy and compliance while insuring the disciplines necessary to achieve Company goals, strategic plans and expectations
- Other duties as deemed necessary by management
- Demonstrated previous experience at driving the design, development and commercialization process within the Healthcare Industry.
- 5+ years’ experience in an Engineering/New Product Development role within Healthcare Manufacturing environment
- Bachelor’s Degree in Engineering, Industrial or Material Science field of study
- ISO 13485 Quality Experience, 510K, and cGMP Experience desired
- Excellent organizational, leadership, and management experience
- Strong computer skills/experience, including MS Office Suite