Job Description

As the Product Development (R&D) Engineer, you will be responsible for the timely and quality execution and management of assigned design and development projects in order to meet the company’s short term and long-term goals.

You will participate in and/or organizing key customer interactions and
communications in partnership with the sales and marketing team to document and develop design concepts and develop them through, in accordance with the company design quality system, through full production launch and maintenance. You will be “hands on” and leverage your excellent CAD knowledge and skills (Solidworks preferred) for the creation of parametric models that drive the creation of ASME Y14.5 compliant manufacturable prints.

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What you will be responsible for:

• Participate in, and support the following product development activities: concept, planning, design and execution stages of major new products or product enhancements, Risk assessment, Prototyping, Design for Mfg. and Design for Inspection, Testing (Protocol, authorship, Physical Testing, and Test Report generation), Pilot Production, Design reviews, Verification, Validation, Pre-production
• Interact with remote and internal design and manufacturing resources to design for manufacturability, reliability and cost-effectiveness
• Listen to customers and generate product inputs that define the design of entire systems as well as detailed components of the system
• Material selection, manufacturing methods, inspection techniques and critical measuring
• Use your knowledge of 3D CAD design and print generation (Soldiworks preferred) implementing appropriate ISO standards, DFM & DFI principles, and GD&T
• Communicate ideas, schedules, budgets, and testing results effectively to team members, surgeons, and executive management
• A willingness to work directly with cadavers and in surgical situations
• Research design options and perform experiments to determine potential design feasibility and design for manufacturability and inspection
• Be a productive member of cross-functional teams to assist in the creation of design documents for assigned projects, as required by applicable medical device standards and internal procedures

Qualifications

Education and Experience: Bachelor’s degree in Mechanical Engineering or equivalent engineering discipline

3+ years’ mechanical design and manufacturing experience of which 2+ years of actual product development experience bringing innovative product to market from conception to launch in a regulated industry.

MS Office computer software including Word, Excel, PowerPoint, and Project. This job
includes the necessity to travel 20-30% of the time when needed. (to attend surgeon meetings, vendor site visits, trade shows, etc.).

Additional Information

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