The Medical Systems Process Engineer will focus on developing and documenting the procedural steps for the clinical indications that the Galen Robot supports. Additionally, the position will provide the highest level of engineering support for devices being developed, and general support for devices installed in the field and for ongoing engineering projects. The position also provides support to Marketing and Business development projects as requested.
Job Summary: Medical Systems Process Engineer
- Develop and then document detailed clinical procedure steps for the indications the Galen Robot supports.
- Conduct and support usability and market research studies.
- Support Clinical studies
- Support Market and Business Development projects as requested
- Support the development of the product road map
- Participate in the R&D plan supporting the development and launch of next generation technologies and related services.
- Champion the Company’s culture with an emphasis on team building, empowerment, accountability, creativity, achievement and speed.
- Achieve objectives and project completion within budget and timeline.
- Provide technical hands-on support to drive engineering activities, including supporting product design/enhancements.
- Support implementation and refinement as required of formal process to support established engineering processes.
- Proactively support Company goals and objectives, policies and procedures, the Quality System Regulation,ISO/MDD regulations, and other regulatory requirements.
- Maintain a professional and credible image with key physicians, consultants, suppliers, and co-workers.
- Perform other duties as assigned.
- Ensure all activities conform to FDA requirements for GMP/QSR and ISO13485.
- Support a work environment of continuous improvement that supports Galen’s Quality Policy, Quality System and the appropriate regulations for the area supported.
- Keep manager informed of changes in work schedule and/or workload.
- Regularly recommend and implement methods of improving the customer experience.
- Support Company goals and objectives, policies and procedures, Good Manufacturing Practices, and FDA regulations.
- Bachelor’s Degree in engineering or equivalent experience is required.
- Minimum 3 plus years related experience in the medical device industry in addition to at least five years of engineering experience or equivalent is desired.
- Ability to think outside the box and come up with creative solutions to advance and support our solutions.
- Ability to manage diverse, simultaneous projects of varying complexities.
- Strong relationship and problem-solving skills.
- Professional and positive approach, self-motivated, team player, creative with the ability to work on own initiative.
- Hands on biomedical, engineering, and technical capability.
- Ability to work in front of the customer at the customer site.
- The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Must be able to lift 40lbs
- Position requires sitting for prolonged periods as well as standing for periods of time.
- The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Other duties as assigned
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