Position: Mechanical Design Engineer
Industry: Medical Device
Location: Austin, TX
About the Company
Our Client is a multi-business medical device company that develops products based on its pioneering ablation technology. Current applications include: Arthroscopic surgery, Spine surgery, Dermatologic surgery, Ear, nose & throat surgery (ENT), and General surgery.
We are seeking a Mechanical Design Engineer to join the Coblation technology group. This individual will provide expert design and technical leadership in the design and development of products. In addition he/she will assist manufacturing transfer, market release, and post-launch product support.
The Design Engineer will be joining a team of high level individuals who own individual projects, but leverage each otherâ€™s input and strengths. This teamwork and collaboration are key to our clientâ€™s success. Ability to communicate effectively will be strong factors in the candidate selection process. The right candidate must have a solid technical foundation and will be able to demonstrate learning and application of that knowledge in their engineering career. Candidate should enjoy learning and sharing learning with others.
This position will report to a Sr. R&D Manager.
â€¢ Designs and develop complex devices and lead project teams in this effort
â€¢ Possesses an in-depth understanding of ArthroCare technology.
â€¢ Evaluates customer needs in order to conceptualize innovative designs.
â€¢ Works closely with directors, product managers, project managers and project engineers from R&D and other supporting departments, in order to drive projects to completion on schedule.
â€¢ Ensures that product development activities are performed to governing standards and regulatory requirements and ArthroCare procedures and policies.
â€¢ Resolves problems using solutions that involve new techniques, technologies, or concepts.
â€¢ Works closely with surgeons and marketing group to analyze and define customer needs.
â€¢ Conducts design verification and validation activities.
â€¢ Works closely with Process and Manufacturing Engineering groups to support transfer to production, and sustaining engineering.
â€¢ Confers with management, production, and marketing staff to determine engineering feasibility, cost effectiveness, and customer demand for new products and changes to existing products.
â€¢ Maintains a working knowledge of new technologies that may improve product performance, reduce cost of goods, or improve manufacturing operations and develops recommendations accordingly.
â€¢ Supports implementation of designs and processes to improve device cost, performance and/or reliability.
â€¢ Produces quality documentation associated with new product development.
â€¢ Coordinates and cooperates with suppliers, contractors and personnel on all levels.
â€¢ Manages the working partnerships with multiple outside resources contracted for the concept/product development, prototype/pilot fabrication, and testing of devices.
â€¢ BS in Mechanical Engineering, Biomedical or similar discipline with medical device experience. MS or PhD a plus.
â€¢ 2 â€“ 4 years experience in the medical device industry. Experience designing and developing handheld disposable devices such as instrumentation systems, laparoscopic devices, surgical tools and/or electrosurgical elements highly desired.
â€¢ Must have the ability to manage the development of products from inception to market launch â€“ including project management, verification, and validation activities.
â€¢ Strong CAD design / SolidWorks skills required.
â€¢ Knowledge of Word, Excel, and Project required
â€¢ Familiarity with ISO, MDD Quality Systems and FDA Quality System regulations a plus
â€¢ Ability to alter approach to work collaboratively with a range of people and personalities
â€¢ Ability to gain the respect of peers though a cooperative team effort
â€¢ Confident in the role and key functions of the position
â€¢ Demonstrated ability to work proactively in a team environment with multiple disciplines
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