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Senior Product Development Engineer

5 months ago

Pittsboro, United States Gilero Full time

Job Purpose:

Responsible for developing new medical devices

Duties:

  • Act as technical lead in the development of new products, primarily class I and class II single-use medical devices
  • Lead Project Management activities such as budgets, resources, timelines, and deliverables
  • Provide primary interface to customer for communication of project status and plans
  • Develop and define product and customer requirements
  • Lead product and process risk assessments
  • Participate in design reviews
  • Write and execute protocols for design verification and validation
  • Lead test method development and have strong knowledge of measurement system analysis (e.g. calibration, accuracy, gage R&R, etc)
  • Oversee and perform testing and inspection of prototypes and pre-production products
  • Analyze test data, interpret results and formulate conclusions
  • Lead investigation of device failures to determine root cause and corrective action
  • Develop assembly methods and oversee prototype builds
  • Lead process development activities, write work instructions, and develop in process inspection procedures
  • Generate CAD models for test or assembly fixtures
  • Write and execute protocols to assess manufacturing process capability (IQ/OQ/PQ)
  • Investigate, evaluate and select product materials
  • Prepare detailed component and assembly drawings
  • Prepare documentation to support design history files and regulatory submissions
  • Maintain DHF and ensure documents are complete, accurate, and current
  • Communicate effectively with customers and vendors in a technical capacity

Skills/Qualifications:

  • BS in Engineering or equivalent technical degree
  • 5 - 12 years relevant experience in product development, preferred
  • Proven ability to lead a product development program
  • Experience with SolidWorks, Pro/Engineer and/or other 3D CAD modeling software
  • Experience with plastics and/or silicones, particularly injection molding
  • Knowledge of medical device regulations (FDA/ISO)

Personal Attributes:

  • Meets Gilero Core Values: Collaboration, Innovation, Excellence, Integrity
  • Comfortable and productive in a fast-paced, entrepreneurial environment
  • A self-starter seeking a career opportunity with potential for internal advancement, seeking responsibility for core activities and providing high quality service to internal and to external clients
  • Commitment to excellence and quality service to external and internal customer
  • Commitment to established policies and procedures, while contributing to continuous improvements
  • Excellent communication skills (oral and written)
  • Proficient (or better) computer skills, including Excel and Word