R&D Engineer

Job Description:

Designs and analyzes mechanical systems, equipment and packaging. Conducts feasibility studies and testing on new and modified designs. Directs support personnel in the preparation of detailed design, design testing and prototype fabrication. Provides design information to drafting for packaging documentation. Jobs that provide engineering technical support in this field should be assigned to this job family.

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Job Requirements:

The R&D Engineer works directly with customers to develop solutions addressing their needs.

The R&D Engineer is responsible for the project management of the projects she/he leads.

The R&D Engineer applies internal product development, design change and change control procedures and ensures that the resulting product documentation is in compliance with the internal Quality System's procedures as well as to the applicable directives and standards (e.g. MDR; FDA 21 CFR 820; ISO 13485; ISO 14971).

The main areas of responsibility are the development of designs and processes for producing injection molded parts. Other areas may include development and support of medical devices, like dental polishers or handheld material extrusion devices.

·         Work with product management to develop innovative devices or systems to address challenges for customers (mainly dentists).

·         Interface with users (dentists), internal partners (Regulatory, QA/QC, Supply Chain, Marketing, Customer Service, Sales) and vendors to translate user needs into product concepts and refine them all the way into manufacturing.

·         Lead the design process, work on CAD models, and execute design control steps and documentation from the idea inception to launch readiness.

·         Lead or contribute to line extension and design change and design development projects within cross-functional teams.

·         Perform sustainment activities on the developed, and legacy, products to problem solve and improve/maintain quality, manufacturability, or cost.

·         Ensure that design development and change activities follow design and development procedures as well as applicable regulatory and quality system requirements.

·         Create R&D deliverables (verification and validation data, risk management documentation) according to internal procedures and in compliance with MDR 2017/745 and applicable standards (e.g., ISO 13485, ISO 14971)

·         Communicate and discuss with company management and stakeholders, feasibilities results and design choices.

·         Identify and work with external consultants (FEM, flow analysis …), mold vendors and operations to optimize manufacturability.

Supervision of internal and external testing activities

Operating Company:

Kerr

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