Senior Project Engineer

6 days ago

Norristown, Pennsylvania, United States Globus Medical Full time
About the Role

Globus Medical is a leading manufacturer of medical devices, and we're seeking a highly skilled Senior Project Engineer to join our team. As a Senior Project Engineer, you will be responsible for designing, implementing, and sustaining designs for medical devices. You will work closely with cross-functional teams to develop and launch new products, ensuring they meet the highest quality and regulatory standards.

Key Responsibilities
  • Apply knowledge of engineering principles to design, develop, and test all aspects of electro-mechanical surgical instruments
  • Support the creation of product requirements, specifications, and test documents
  • Support the development of manufacturing test fixtures and documentation
  • Obtain market feedback from surgeons and other customers to determine functional and design specifications for new product development
  • Create and maintain project plans and FDA complaint Design history Files (DHF) for each project
  • Manage all aspects of assigned projects to ensure timely completion of tasks while remaining in full compliance with Globus quality system and other applicable regulatory bodies
  • Design and develop instruments using Creo software
  • Partner with in-house prototype shop and outside vendors for rapid prototyping and evaluation
  • Perform design verification and validation activities to ensure designs meet specifications
  • Collaborate with marketing and product managers to develop forecasts and market plans
  • Assist in the writing of regulatory applications to the FDA and other regulatory bodies
  • Partner with the operations department to setup manufacturing and/or purchasing as appropriate for each project
  • Participate in product introductions through sales training, customer calls/visits, etc.
  • Maintain diligent post introduction monitoring to address and customer requests for changes
  • Research industry and direct competitors on an ongoing basis to ensure that Globus has cutting edge technology in all markets entered
  • Partner with manufacturing, internal testing, and external customers when presented with quality issues. Prioritizing work to identify the root cause and create a corrective plan that ensures timely resolution of issues
  • Maintain professional and technical knowledge by attending educational workshops, reviewing professional publications, establishing personal networks, and participating in professional societies
Requirements
  • Bachelor's Degree in Mechanical Engineering with 8+ years of experience or Master's Degree in Mechanical Engineering with 5+ years of experience
  • Electro-mechanical background
  • Experience with 3D modeling CAD software, PTC Creo preferred
  • Strong aptitude for mechanical systems, materials, and manufacturing methods
  • Familiarity with a variety of industry concepts, practices, and procedures
  • Experience in Medical Device product development a plus
  • Ability to work independently and as a key contributor in small teams
  • Excellent oral, written, and communication skills
  • Motivated self-starter with good time management and organizational skills
  • Proficient in Microsoft Office applications
  • Ability to travel up to 10% of the time

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