PURPOSE OF JOB:
Use engineering knowledge to design and develop innovative medical devices or components/subsystems in support of company’s strategic plan.
RESPONSIBILITIES:
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Develop and prototype new product designs and enhancements based on user needs.
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Participate on cross-functional teams that manage projects from concept through commercialization.
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Solve engineering problems at the component through system level.
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Conduct testing utilizing existing test protocols and methods or develop new ones as needed.
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Generate protocols and reports and perform verification and validation testing
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Prepare document change orders (DCR) and coordinate the deployment of changes.
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Assign work to technicians and temporary workers as needed.
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Complete projects (including product enhancements) in a manner consistent with corporate objectives.
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Contribute to the intellectual property position of the company via invention and patent applications.
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Maintain accurate documentation of concepts, designs, drawings and processes.
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Maintain current knowledge of competitive technologies in addition to medical, technical and biomedical developments related to company products.
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Provide engineering and technical support of products as well as physician in-service programs.
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Oversee outside vendors and consultants as required.
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Provide engineering support in the resolution of product complaints and/or safety issues.
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Work with other engineering, manufacturing, clinical affairs, sales and marketing and quality assurance staff to coordinate pilot production of new products.
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Support company goals and objectives, policies and procedures, QSR and FDA regulations.
PREFERRED EDUCATION:
Bachelor’s degree in Mechanical or Biomedical Engineering.
PREFERRED EXPERIENCE:
Minimum of 5 years of experience in the medical device industry, preferably catheter based.
ADDITIONAL SKILLS:
Working knowledge of CAD, preferably Solidworks. Ability to perform word processing and create basic spreadsheets. Communication skills. Ability to work independently or in a team setting as needed.
