Department: Engineering

Job Summary:

This position is responsible for research and development of new products/processes, engineering documentation, and other projects as assigned by Engineering Manager or President.

Main Responsibilities:

This position at INRAD Inc. entails numerous responsibilities including, but not limited to the following:

  • New product development, including all activities pertaining to the conceptualization, design and development of new medical devices in accordance with INRAD’s design control procedure, quality system, and GMPs.
  • Developing project plans and managing project timelines and budgets. Ensuring communication and accountability of key project milestones and deadlines.
  • Establishing and managing relationships with suppliers
  • Maintenance and manufacturing support activities for INRAD legacy products
  • Identifying and addressing additional training needs  
  • Initiating and Investigating Complaint, Variance, Corrective and Preventive activities
  • Contributing to process improvements
  • Implementing cost saving measures
  • Writing, Reviewing and approving device history record documentation and drawings
  • Performing Calibration/Preventive Maintenance
  • Design Control / Process and Design Verification and Validation
  • Working with Customers and Suppliers
  • Technical support for regulatory submissions (i.e. 510k)
  • Performing Risk Analysis
  • Implementing new equipment
  • Additional projects as assigned by management

Job Qualifications:

  • Four (4) year college degree or higher in Mechanical Engineering or Biomedical Engineering with a background in Mechanical Engineering
  • FMEA, SPC, and Strong PC Skills
  • Proficient in mechanical drafting and 3D modeling software (Solid Works is preferred)
  • Additional technical training is preferred

Job Experience:

  • Some experience desired, but not required
  • Previous Medical Device development experience preferred

Skills / Competencies:

  • Understand Good Manufacturing Processes (GMP’s)
  • Ability to read, understand, and follow specifications
  • Ability to follow verbal and written instructions
  • Proficient mathematical skills
  • Understanding tolerances and variations
  • Able to read / create drawings
  • Understand production methods, manufacturing techniques, statistical methods
  • Ability to multi-task proficiently
  • Strong project management skills
  • Ability to use measuring devices/hand tools
  • Demonstrate good judgment and analytical skills
  • Proficient computer skills
  • Good interpersonal skills
  • Data collecting and charting
  • Performing multiple tasks with minimal supervision
  • Good communication skills (written and verbal)
  • Good attention to detail
  • Ability to adapt to changing environment/priorities
  • Mechanical aptitude
  • Proficient Mechanical Drafting skills
  • Proficient in mechanical drafting and 3D modeling software (Solid Works is preferred)

Physical Requirements:

  • Good vision
  • Good hand-eye coordination
  • Able to lift 50 lbs
  • Able to sit or stand for four (4) hours at a time
  • Able to work with / assemble small components
  • Moderate twisting, bending, and lifting
  • Able to travel on occasion