Project Engineer (Located in Cleveland, OH)

In this role, the individual is primarily responsible for performing activities in support of the development and manufacture of tissue and polymer based medical devices based on proven scientific concepts.

Duties and Responsibilities:
• Interpret customer and market needs into documented product requirements
• Refine product and process characteristics through research and experimentation
• Evaluate product risks using traditional methods and implement control mechanisms to reduce risks to acceptable levels.
• Create product specifications, raw material specifications, and manufacturing procedures.
• Demonstrate the ability of products to meet requirements through verification and validation testing.
• Become familiar with and follow design control procedures according to FDA and ISO requirements.
• Plan and manage project work in accordance with defined deliverable targets.
• Support regulatory product submissions through testing and documentation.
• Specify materials and equipment required to achieve objectives.
• Identify and direct work with outside strategic partners as required.
• Research scientific and clinical publications to support methods or conclusions
• Generate technical reports, making data-based recommendations for the products.
• CAD design of product, tooling and fixtures as required
• Comply with regulatory guidelines for design control

Qualifications:
• A Bachelor’s degree in Engineering or a related field is required.
• Undergraduate experience with tissue engineering and/or polymer science is preferred, however any prior experience with medical devices is desirable.
• Experience working in cleanroom environments is highly desirable.
• Strong written and verbal communication skills, with the ability to work closely with both internal and external team members.
• Proficient in the use of personal computers, including the use of Microsoft Outlook, Microsoft Word and Microsoft Excel.
• The ability to make necessary decisions and/or take action required to carry out job duties.
• The ability to operate independently and to self-manage all activities in working towards the common goals of the organization.

 

Salary Range: $45,000 – $55,000

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