Sr. Product Development Engineer

Job Type

Full-time

Description

Weiss-Aug Group is an internationally recognized leader in precision metal stamping, injection molding, value-added assembly solutions and tooling.

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.

Join our team where every day we push the boundaries of manufacturing technology to help our customers produce the best medical devices so that people may live healthier lives.

We are currently searching for a Sr. Product Development Engineer with at least 10 yrs. experience in a manufacturing and/or product design (R&D) environment will represent the customer in order to ensure that the customer's expectations are clearly understood and being met.

REQUIREMENTS

• 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.
• Responsible for fostering a technical relationship with the customer to encourage additional sales through future product development areas and facilitate the overall sales cycle.
• Represent the customer in order to ensure that the customer's expectations are clearly understood and being met.
• Provide leadership to technical teams responsible for successful launch of multiple complex programs.
• Service and grow our program base within the Medical / Life Science Industry (Technical Sales)
• Responsible for overseeing the coordination and on-time/in-budget completion of all projects which may involve some or all of the following technologies: progressive stamping, insert molding, factory automation and other related tooling/processes. Oversee all aspects of programs beginning at customer order through to successful transfer to Manufacturing.
• 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.
• Ability to participate in product design (R&D) meetings with Medical Customers in relationship with Weiss-Aug Manufacturing technologies.
• Oversee the creation and distribution of project schedules. Ensure that project milestones and deadlines are met including assignment of responsibilities, monitor progress and report status to management/customer.
• Facilitate Tooling Kickoff, Specification Review, Design Review and Lessons Learned (Post Mortem) Meetings.
• Oversee the development and input of initial BOM and detailed Routing
• Oversee the initiation and/or coordination of the change control process (ECO) relating to Engineering documentation.
• Jointly responsible for successful transfer of tooling to Manufacturing along with Toolroom and Design Engineering functions.
• Oversee the selection and management of key suppliers as required by project. Oversee the completion of requisitions for approval by management 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 new and/or special equipment needs along with Manufacturing Engineering.
• Manage program risks by considering tradeoffs between time, cost, customer needs and product and manufacturing physics.
• Interface with customer on technical and schedule-related issues. Ensure program progress is communicated to customer at regular intervals.
• Mediate conflicts between departments. Forge compromise and consensus between team members.
• Assist in identifying areas for continued improvement and opportunities to gain organizational knowledge.
• Participate in customer, internal and registrar quality system audits.
• Support Sales and New Product Development Teams. May 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 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 generating test plans, writing protocols, conducting design verification/validation, and processing validation testing Working knowledge of the U.S. and International standards governing the design, development, testing, and manufacture of medical devices.