Product Development Engineer

Duties:Support the development new products, primarily class I and class II single-use medical devices,Prepare documentation to support design history files and regulatory submissions,Maintain DHF and ensure documents are complete, accurate, and current,Define product and customer requirements,Perform product and process risk assessments and participate in design reviews,Assemble and prepare prototypes for testing and client meeting purposes,Write protocols and reports to test products and assess manufacturing process capability,Test method development,

  • Oversee and perform the testing and inspection of prototypes and pre-production products
  • Investigate, evaluate and select product materials
  • Assist with process development activities, write work instructions, and develop in process inspection procedures
  • Write protocols and manage the execution of process, equipment, and design validations
  • Prepare detailed component and assembly drawings
  • Communicate effectively with customers and vendors in a technical capacity
  • CAD/SolidWorks modeling of testing or assembly fixtures


  • BS in Engineering or equivalent technical degree
  • 2-5+ Years Experience
  • Proficient in SolidWorks, Pro/Engineer and/or other 3D CAD modeling software
  • Experience with plastics and/or silicones, particularly injection molding
  • Knowledge of ISO-9000 and/or FDA QSR Design Controls a plus

Personal Attributes:

  • A team player with integrity
  • Comfortable and productive in an 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
How to apply: 

To be considered for this position, send your resume and cover letter to

Job Status: