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Our clinical stage medical device client is adding a Principal Mechanical Engineer to the team. The Principal Mechanical Engineer will lead the design and development of new medical devices and the continuation engineering of existing medical devices. Compiles and analyzes operational, test, and research data to establish technical specifications for designing or modifying products, processes, and materials. Uses data to drive decision making and when data is not available designs experiments, creates prototypes, or completes calculations to support decision making.  Develops new products while interfacing with customers, suppliers, and internal departments to achieve the desired product specifications.  The goal is to develop products that meet the end users’ needs.  Success in this position relies heavily on meeting aggressive date targets while maintaining accountability and using experience and judgement to develop products and meet goals with minimal supervision. 
Your role with the company:

The Principal Mechanical Engineer is a key position in the R&D organization.

  • Innovative Product Development: Generate unique solutions that cater to market needs, leading to the evolution of new products or processes.
  • Complex Engineering Work: Execute intricate engineering tasks across technology development, product design, material/product testing, specification preparation, and more.
  • Sophisticated Problem-Solving: Utilize advanced techniques to solve complex problems, providing sound design recommendations and drawing actionable conclusions from comprehensive test data.
  • Technical Reporting: Prepare detailed reports communicating technical findings effectively within the technical community.
  • Project Coordination: Design and coordinate complex engineering tests and experiments, managing and documenting project progress while recommending necessary revisions.
  • Cross-Functional Collaboration: Collaborate across various departments including process development, quality, manufacturing, regulatory, clinical, and marketing teams to ensure project success.
  • End User Interface: Engage directly with Physicians and Medical personnel to gather feedback on device concepts and performance.
  • Product Requirement Translation: Translate customer needs into product requirements and design specifications, ensuring comprehensive engineering documentation, including product requirements, component specifications, equipment specifications, technical reports, and test methods.
  • Experience-Driven Outputs: Progressive experience with high-volume disposable, reusable, and capital product types emphasizing reliability, low cost, and high quality.
  • Feasibility Assessment: Assess the feasibility and soundness of proposed engineering evaluation tests, products, or equipment.
  • Mentorship & Direction: May train and/or provide work direction to technicians and entry-level engineers.
Desired Profile:
  • Bachelor's degree in Mechanical Engineering, or related field.
  • Proficiency in SolidWorks (certification preferred). CAD prototyping, iterating, and designing for injection molding/manufacturability will be a large component of this role.
  • 10+ years of product development experience in medical devices.
  • Strong understanding of design and product development processes
  • Strong background in developing complex electromechanical systems that encompass both capital and disposable components
  • Experience with developing reusable medical products requiring reprocessing
  • Expertise in packaging design, labeling, sterilization, and biocompatibility.
  • Electromechanical design experience
  • Proficiency with JMP statistical software 
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