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Design Engineer

2 months ago

Princeton, United States Medical Device Startup Full time

Design and Manufacturing Engineer


The ideal candidate possesses both a high level of technical expertise and an innate passion to build. You will play a critical role in creating and refining designs and processes in order to improve the product design, manufacturability, quality, and productivity. 

 

You will manage and oversee the manufacturing of a medical device by our contract manufacturer. Real world experience in medical device development, production, and quality processes under FDA good manufacturing practices and ISO standards required.


DUTIES AND RESPONSIBILITIES:

  • Oversee the manufacturing of an FDA regulated medical device
  • Contribute to the design of specific components
  • Create and maintain work instructions and manufacturing specifications
  • Collaborate cross-functionally to facilitate production process and evaluate potential changes
  •  Executing design change implementations and supports the overall design change process
  •  Evaluating the manufacturing processes for opportunities in productivity gains
  •  Identifying manufacturing issues (design/process/component) and drive resolution by participating on cross-functional or project teams
  • Researching and resolving electro-mechanical, production assembly and/or test issues in a timely manner
  • Prepare all documentation in accordance with FDA regulations including 21 CFR Part 11 
  • Creating new templates updating and revising Supplier Quality Agreements and quality requirement
  • Perform detail risk assessment based on patient safety, product quality and data integrity
  • Perform verification/validation to confirm design specifications and evaluate potential failure mode
  • Coordinate project schedule with customers, supply chain, internal resources, and supervisors
  • Documentation and organization of design-related data / technical drawing packages following design and revision controls per ISO 9001 and internal standard practice. Knowledge of ISO 13485 is desired
  • Work independently on assignments and multi-task on several projects


Qualifications:

  • Bachelor's Degree or higher in Electrical or Mechanical Engineering
  • 3 or more years relevant experience
  • Proficiency in SOLIDWORKS
  • Princeton, NJ 08540: Reliably commute or planning to relocate before starting work (Required)
  • Excellent oral and written communication skills
  • FDA/ISO/Med Device experience required
  • Willing to travel up to 10%