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Development Engineer

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Job Title: Development Engineer

Job Status: Full Time Exempt

Reports to: Director, R&D

Location: Dallas, TX

Amount of Travel Required: up to 20%

Work Schedule: Full-time

Positions Supervised: None

 

Position Summary:

The Development Engineer leads mechanical and electromechanical development activities for the company’s Class II device(s). This individual is responsible for the design, development, verification and validation of new products, and works closely with Applied Research, Marketing, RA/QA and contract manufacturers to drive new product initiatives. The Development Engineer is a critical team member, reporting directly to the Director of R&D.

 

Essential Functions:

  • Essential functions of the position include but are not limited to the following. Other duties may be assigned.

  • Primary manager of assigned new product development projects

  • Lead design and development from concept to clinical stage and commercialization

  • Execute detailed mechanical component and assembly design CAD models

  • Generate detailed product drawings, component specifications and packaging documentation

  • Create, manage and lead completion of FDA and ISO compliant design history files and design master records

  • Create, maintain and improve controlled technical documents (e.g., risk analysis, test protocols and reports, design reviews)

  • Ensure company compliance with Good Design Practices

  • Support design of tooling and fixtures to optimize the manufacturing processes

  • Support Applied Research with design input for future product development

  • Support Regulatory Affairs with manufacturing materials and process flow documents

  • Support Quality in Complaint Handling and other areas of regulatory compliance.

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POSITION QUALIFICATIONS

Experience and Education:

  • Minimum B.S. degree in mechanical or biomedical engineering

  • Minimum 5+ years of life science product development experience

  • Experience with design of machined and injection molded components

  • Experience in brainstorming, ideation and conceptual design

  • Experience in analytical processes (e.g., FEA, numerical modeling, Risk Analysis, DFM)

  • Hands-on technical skills for graphic presentation of ideas, prototyping, testing

  • Experience with contract manufacturer development and working relationships

  • Experience establishing and driving key development initiatives and NPI/design transfer of a product to Contract Manufacturing

  • Preferred experience with sterile disposable devices

  • Demonstrated understanding of FDA GDP regulations and ISO 13485

  • Preferred working knowledge of FDA requirements for Good Laboratory Practices

  • Effective working independently with minimal direction and within project teams

  • Excellent organizational and communication skills

  • Hands-on, driven work ethic and entrepreneurial spirit

  • Willing and able to travel as needed (typically 15-20%)

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Computer Software / Programs:

  • Proficient in CAD (e.g., Solidworks)

  • MS Office, MS Project and general business software applications

  • Familiarity with statistical analysis systems (e.g., MATLAB, SAS) preferred

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