Product Development Engineer

Job Description

Job title: Product Development Engineer

Location: Durham, NC 27703-Onsite

Duration: 9-month contract

Pay range: $45.00/hr to 48.00/hr

Job description:

Essential Job Duties:

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• (Specific responsibilities and tasks an individual would be expected to perform in the role.
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Functional people manager may determine additional job duties)

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• Support product development projects for new models and design changes for improved user experience, training effectiveness and realism, manufacturability, reliability, and cost.
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• Resolve unmet model needs and engineering challenges through rapid prototyping, design, and
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• testing, while collaborating with researchers, product management, scientists, KOL surgeons, and engineers.
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• Create design documentation including part specifications, drawings, BOMs, test protocols, and reports.
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• Interface with suppliers, manufacturing, and quality engineering to prepare for scalable production of the models, define new processes, and comply with quality systems.
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• Perform root cause investigations for design-related issues and design failure mode analyses.
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• Document and provide manufacturing process instructions to the manufacturing trainer for new and revised models.
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• Lead successful introductions of new and revised models to the manufacturing line.
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• Develop products that meet quality control standards and influence quality control procedures
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and practices.

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• Sustain existing designs to achieve cost targets and maintain component supply continuity.
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• Test product packaging and work with vendors to convey requirements and select the most appropriate design.
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Required Skills:

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• Minimum 2 years’ experience in design and product development.
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• Knowledge and execution of ISO 9001 quality systems.
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• Ability to work safely with animal tissue and apply knowledge of basic anatomy as required by the position.
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• Working knowledge of surgical and laboratory terminology, equipment, materials, and procedures relevant to product development.
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• Demonstrated hands-on problem-solving of mechanical engineering challenges.
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• Experience with component design and fabrication methods including machining, 3d printing, laser/die cutting, and thermoforming.
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• Proficient with CAD models (eg SolidWorks) and creating engineering drawings.
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• Familiar with all phases of the product development lifecycle, change and design control systems and processes (eg Agile).
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• Ability to work with standard computer applications: Smartsheet, Microsoft Office, Excel, Outlook, PowerPoint, Visio.
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• Familiarity with Good Documentation Practices.
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• Strong organizational skills and ability to support multiple fast-paced projects simultaneously.
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• Required Education and Training (As applicable - Specific education and training that an individual must possess to successfully perform in the job)
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• Minimum bachelor’s degree in mechanical or biomedical engineering or equivalent.
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Preferred Skills:

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• MS degree in an engineering discipline, preferably Mechanical or Biomedical Engineering.
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• Experience with SolidWorks.
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• Prior experience working in an FDA/ISO regulated environment, preferably medical device.
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• Experience with fabrication methods including injection molding, hydrogel molding, and silicone molding/casting.
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• Experience resolving quality issues from production or assembly. Familiarity with Good Manufacturing Practices.
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• Experience with design of experiments and statistical testing.
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• Experience in lean manufacturing, six sigma, and standardization techniques.
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• Experience with packaging design, selection, and vendor management.
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“We are an equal opportunity employer. It is our policy to provide employment, compensation, and other benefits related to employment without regard to race, color, religion, sex, gender, national or ethnic origin, disability, veteran status, age, genetic information, citizenship, or any other basis prohibited by applicable federal, state, or local law.”