Description
Weiss-Aug Group is an internationally recognized leader in precision metal stamping, injection molding, value-added assembly solutions and tooling, serving customers in a variety of industries. Our Surgical Products Division serves the medical device industry and has created special capabilities for the manufacture of surgical instruments. With expansive technology in R&D, laser processing, insert molding, production machining, we need the best minds to serve our customers and ultimately patients around the world.
We are searching for a Sr. Product Development Engineer with at least 10 yrs. experience in a product development/design environment (R&D), including early-stage exploration/definition, detailed design, and connection/transfer to manufacturing. Ability to understand and clearly define use conditions and represent the needs of the customer is essential, as is experience leading cross-functional development teams (Design, Engineering, Tooling, Quality, Manufacturing, and Sales). A bachelor’s degree in mechanical engineering, biomedical engineering, or equivalent is required.
REQUIREMENTS
- Oversee all aspects of programs from concept definition through successful transfer to manufacturing, advocate for the customer and needs/requirements.
- Provide leadership to cross-functional technical teams responsible for successful launch of multiple complex programs.
- Responsible for overseeing the coordination and on-time/in-budget completion of all project tasks which may involve some or all of the following technologies: progressive stamping, insert molding, factory automation and other related tooling/processes.
- Oversee the creation and distribution of project schedules. Ensure that project milestones and deadlines are met including assignment of responsibilities.
- Facilitate design definition, design reviews, tooling kickoff, and project postmortem activities.
- Understand and meet Regulatory (FDA) requirements and processes for development.
- Advanced Product Quality Planning (APQP) including completion of related documentation, including but not limited to: DOE’s, FMEA’s, Process Flowcharts, Control Plans, Capability Studies and Gage R&R’s.
- Oversee the creation of BOMs and initiation of the change control process (ECO) relating to Engineering documentation.
- Jointly responsible for successful transfer of tooling to Manufacturing along with Tooling and Design Engineering functions.
- Oversee the selection and management of key suppliers and the completion of requisitions for purchased tooling or other product or services. Interface with outside suppliers to ensure they provide product or services on-time and to specifications.
- Assist in determining needs for additional personnel and/or training in order to meet program needs.
- Identify and facilitate addition of personnel, training, and special equipment needs to support project success.
- Interface with customer on technical and schedule-related issues, ensure program progress is communicated to customer at regular intervals.
- Participate in customer, internal, regulatory, and quality system audits.
- Support Sales as needed to assist in identifying potential leads and opportunities.
Requirements
- Minimum of a bachelor’s degree in mechanical engineering or biomedical engineering
- Minimum of 10 years of medical device or life science industry experience, preferably in a product development engineering position.
- Experience in developing and implementing procedures, methods, and tools for the manufacture or design and testing of medical products.
- Experience in contributing to technical and cross-functional teams in accomplishing projects with notable impact(s) on company objectives.
- Experience in Regulatory (FDA) requirements and processes for development.