Job Description
Seeking a Principal Product Development Engineer to design precision-engineered medical devices. Applicants will be expected to perform as an individual contributor and an expert on catheter design and development with emphasis on peripheral intravenous catheters.
Candidates must be highly innovative and enjoy working in a dynamic, energetic, and creative environment. A team player who is looking to excel in a fast-paced, hands-on, and design thinking environment.
Role and Responsibilities
§ Manage projects as a hands-on employee using technical and administrative skills to oversee and complete engineering tasks of high complexity.
§ Able to develop ideas and mechanical prototypes of multiple concepts with available resources
§ Proficient in developing unique concepts, fixtures, and production component designs using 3D CAD (i.e., Solidworks)
§ Have a solid understanding of design considerations needed for high volume manufacturing
§ Develop methods and procedures for testing products or systems to ensure they conform to engineering and customer specifications.
§ Manage design verification and validation testing of the systems, ensuring designs are scalable, reliable, and meet the technical specifications and product requirements.
§ Research, assess and validates the capabilities of equipment, technology choices, and vendors to be used in the product development process.
§ Assist in all facets of regulatory approval process, including participating in component and system level design reviews, test plan preparation and execution, issue troubleshooting / mitigation.
§ A working knowledge of statistics for data analysis and hypothesis testing is required.
Qualifications
§ 7+ of mechanical engineering design and development of medical devices
§ Expert knowledge of high-volume production/assembly fabrication including elements of automation, Design for Manufacturability, plastic injection molding and extrusion.
§ Expert knowledge of Solidworks, FMEA, tolerance analysis, and geometric dimensioning and tolerancing (GDT)
§ Demonstrated hands-on experience building and testing prototype systems in a team environment
§ Must be confident in a highly dynamic and creative environment.
§ 25% travel domestically or internationally
Education
BS in Mechanical Engineering or Biomedical Engineering is required. MS or PhD is preferred.
Additional Notes
All your information will be kept confidential according to the Equal Employment Opportunities guidelines.
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