Location: Glens Falls, NY
R&D Engineer, Glens Falls, NY
This position is responsible for technical aspects of design and development of new medical devices or design changes. Provide input in innovation, design, development and implementation of new or modified products and manufacturing processes, procedures, tooling, and equipment.
Essential Duties and Responsibilities:
- Develop new technology, products, or processes related to new devices or design changes.
- Compile and analyze operational, test, and research data to establish technical specifications for designing or modifying products, processes, and materials.
- Innovate, design, develop, optimize, and implement processes, procedures, tooling, and equipment for new products with specific emphasis on design for manufacturability.
- Generate innovative and unique solutions to market needs. Work is expected to result in development of new or refined products, processes, or equipment.
- Successfully complete engineering work in one or more of the following: technology development, product design and development, test of materials or products, preparation of specifications, process study, research investigation (clinical studies), and report preparation.
- Use fundamental Product Development / DFM tools (FMEA, process flow charts, process capability, six sigma, lean) to reduce variation and achieve capable processes with high production yields where required.
- Perform process optimization through DOEs, response studies, and other statistically valid methods as required.
- Identify techniques to solve complex problems, and provide design recommendations.
- Design and coordinate engineering tests and experiments.
- Coordinate, manage, and document project goals, tasks, and project progress.
- Interface with physicians / catheter lab personnel to obtain feedback on concepts and performance of new devices.
- Translate customer needs into product requirements and design specifications.
- Work cooperatively with Quality, Manufacturing, Regulatory, Clinical, and Marketing on projects to ensure project success and identify product performance requirements.
- Write and execute validation protocols and reports to support design verification, design validation, and process validation (as needed).
- Ensure projects remain compliant with quality system requirements.
- Provide timely responses to the Corrective Action / Preventive Action (CAPA) program, as required.
- Conduct test method development as required by project teams.
- Identify potential product improvement, line extension or vertical integration projects.
- Stay current with and ensure appropriate compliance with FDA regulations, ISO standards, GMP, Design Controls, quality system requirements, and site level SOPs on all projects.
- May perform other duties as assigned.
- Bachelor's Degree in Engineering/Technical Field of Study
- Intermediate skill levels in technical writing, research paper writing, and/or experimental design.
- Advanced level skill in Microsoft Access (for example: modifying default field properties, creating a subform, adding a control button, modifying query criteria and query totals, using conditional formatting and/or viewing data relationships).
- Advanced level skill in Microsoft Excel (for example: using AVERAGE function, merging and centering cells, printing centered page and/or creating a pivot table).
- Advanced level skill in Microsoft PowerPoint (for example: changing picture styles, customizing animation and/or setting automatic slide timings).
- Advanced level skill in Microsoft Word (for example: adding developer tab, creating a macro, formatting table style, inserting comments and/or creating a mail merge).
- Basic SAP or ERP systems knowledge.
Relevant Work Experience
- CAD experience.
- 3 years of experience within a high speed manufacturing environment
- Knowledge of plastic injection molding (including equipment and tooling), plastics assembly methods, extrusion, automated assembly or maching
- Experience in Design for Manufacturing (DFM), Design of Experiments (DOE), Failure Modes and Effects Analysis (FMEA), and Process Validation
- Experience in the medical device industry
All duties and requirements are subject to possible modification to reasonably accommodate individuals with disabilities.
This position description in no way states or implies that these are the only duties to be performed by an employee occupying this position. Employees will be required to follow any other job-related instructions and to perform any other job-related duties requested by their supervisor(s)/manager(s).
This document does not create an employment contract, implied or otherwise, other than an %26quot;at will%26quot; employment relationship