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Senior Product Development Engineer
2 months ago
Weiss-Aug Group is a leading provider of precision metal stamping, injection molding, and value-added assembly solutions. Our Surgical Products Division serves the medical device industry and has developed specialized capabilities for the manufacture of surgical instruments.
We are seeking a highly experienced Sr. Product Development Engineer to lead our product development efforts. The ideal candidate will have a strong background in product development, design, and engineering, with a minimum of 10 years of experience in the medical device or life science industry.
Key Responsibilities:- Oversee all aspects of product development programs from concept definition to successful transfer to manufacturing.
- Provide leadership to cross-functional technical teams responsible for the successful launch of multiple complex programs.
- Responsible for overseeing the coordination and on-time/in-budget completion of all project tasks, including progressive stamping, insert molding, factory automation, and other related tooling/processes.
- Ensure that project milestones and deadlines are met, including assignment of responsibilities and creation of project schedules.
- 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.
- 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.
