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Product Development Engineer

MedSpark Medical Product Design and Development

MedSpark is currently looking for Product Development Engineers to work on future projects.

The Product Development Engineer is responsible for managing product development projects from concept through each stage of design, prototyping, testing, regulatory approval, material selection, tooling and coordination of production launch activities.  Project management duties include establishing project timelines and budgets; coordinating the work of other project team members (Design, Quality, Clinical, Marketing, Engineering and Manufacturing); maintaining FDA required documentation; and reporting to management on project progress.

Other duties include:

  • – Work with clinicians, end users, and marketing to define and evaluate new innovative product concepts.
  • – Lead product development projects from concept generation through design, prototyping, testing, tool design and construction and production launch.
  • – Research materials, products, technologies, test methods, and assembly/fabrication processes.
  • – Coordinate design and fabrication of prototypes for evaluation and testing.
  • – Work with Tooling and Product Design issues to ensure manufacturability.
  • – Work with attorneys on intellectual property issues.
  • – Monitor activities of NPD team members to measure project progress and to ensure achievement of project milestones and timelines.
  • – Prepare and present regular management reports on project status and achievement of required timelines and budgets.
  • – Manage project documentation for compliance to FDA/ISO regulations and procedures including Design History Files.

Job Requirements:

  • – Must have a detailed graphical portfolio of previous product development projects.
  • – Bachelor’s in Mechanical Engineering, Biomedical Engineering, or a related field.
  • – At least three years experience in the Medical Device Development Industry.
  • – Experience must include exposure to a variety of Materials, Manufacturing Processes, and Tooling.
  • – Industrial Design experience highly preferred.
  • – Commercial hands-on manufacturing experience highly preferred.
  • – Experience in complex assembly/part design and in working with CAD software such as SolidWorks, ProE, or Catia.
  • – Proficient in PC tools including MS Word, Project, Excel, PowerPoint, Photoshop.
  • – Well developed project management skills including project documentation, design control process, and ability to produce and deliver project progress presentations to managers, customers and team members.
  • – Outstanding leadership and organization skills.
  • – Intellectual Property protection (NDAs, Patenting, Market Research) knowledge preferred.

How to apply:

  • – In addition to a resume, applicants must provide a detailed graphical portfolio of previous product development projects. Please include a description of your specific involvement with each product and how you personally contributed to the product’s success. Pictures and/or screen-shots of each level of the project’s progression, from concept to manufacturing drawings (dimensions and proprietary information may be masked), are highly recommended to be considered for this position.
  • – PDF file format is preferred for all submitted materials.
  • – Please submit your resume and portfolio to hr@MedSpark.ms