Scientist I Mechanical Engineer

Role Summary

Scientist I/Mechanical Engineer to join Injection Device Development team. You will help accelerate the development of injection devices from concept through submission, industrialization, and launch, working at the intersection of engineering and biopharmaceuticals to deliver life-changing therapies.

Responsibilities

• Design and execute laboratory studies supporting product development and on-market investigations
• Support design transfer and industrialization activities
• Maintain product design documentation
• Support product design changes and continuous improvement effort
• Perform statistical data analysis
• Perform 3D and 2D CAD development in PDM environment
• Develop protocols, and document test results
• Position required up to 25% of travel time

Qualifications

• Bachelor‚Äôs Degree or equivalent education with typically 5 years of experience, or Master‚Äôs Degree or equivalent education with typically two years of experience

Preferred Qualifications

• BS in Mechanical or Biomedical Engineering (MS preferred)
• 3-5 years of experience (MS up to 2 years) ideally in the medical device, drug delivery or other regulated industry
• Strong communication skills (both written and verbal)
• Strong design and analytical skills
• Experience with:
  • Laboratory environment, experiment planning, material control and recordkeeping
  • Physical prototyping (including 3D printing, manual machining, etc) and reverse engineering
  • 3D CAD modeling, detailed engineering drawings, product database management environment and GD&T
  • Statistical analysis tools
  • Manufacturing processes
  • Design controls (in accordance with ISO 13485 / CFR 820.30)
  • Toolroom environment
• Knowledge of material properties, material selection and testing methodologies
• The ability to follow assigned schedules and work in team environment