PURPOSE OF JOB:

Use engineering knowledge to design and develop innovative medical devices or components/subsystems in support of company’s strategic plan.

RESPONSIBILITIES:

Develop and prototype new product designs and enhancements based on user needs.
Participate on cross-functional teams that manage projects from concept through commercialization.
Solve engineering problems at the component through system level.
Conduct testing utilizing existing test protocols and methods or develop new ones as needed.
Generate protocols and reports and perform verification and validation testing
Prepare document change orders (DCR) and coordinate the deployment of changes.
Assign work to technicians and temporary workers as needed.
Complete projects (including product enhancements) in a manner consistent with corporate objectives.
Contribute to the intellectual property position of the company via invention and patent applications.
Maintain accurate documentation of concepts, designs, drawings and processes.
Maintain current knowledge of competitive technologies in addition to medical, technical and biomedical developments related to company products.
Provide engineering and technical support of products as well as physician in-service programs.
Oversee outside vendors and consultants as required.
Provide engineering support in the resolution of product complaints and/or safety issues.
Work with other engineering, manufacturing, clinical affairs, sales and marketing and quality assurance staff to coordinate pilot production of new products.
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.

Route 92 Medical Inc

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