Job Title: Mechanical Engineer I – R&D (Med Device Company)
Temp to Permanent
Onsite 100% St. Louis, MO
0% Travel
0 Direct Reports

Overview:
The Mechanical Engineer I, R&D, is a key contributor to mechanical design projects, particularly for ophthalmic surgery products. This role involves comprehensive product development from conceptual design to product release, including modifications to existing designs, troubleshooting, and project coordination.

Key Responsibilities:
– Lead product development activities and perform mechanical design tasks.
– Generate design concepts for new products based on marketing inputs.
– Collaborate with marketing, manufacturing, and quality teams to ensure designs meet customer requirements.
– Prepare documentation to ensure compliance with FDA accepted control guidelines.
– Create 3D models (SolidWorks/Inventor) and 2D drawings for parts and assemblies.
– Assist R&D technicians in assembling new devices.
– Evaluate new designs against performance criteria and solicit feedback from product managers.
– Review and approve design changes and verification plans for released products.
– Perform engineering activities supporting new product development, product improvements, and maintenance projects.
– Write and review test protocols, perform experiments, and author reports for new product verification.
– Execute engineering bench studies, verification test method development, and verification test execution.
– Operate commonly applicable lab equipment such as scales, temperature probes, torque and force gauges, pressure gauges, oscilloscopes, and environmental chambers.
– Adhere to GLP and cGMP standards for all work performed and records generated.

Scope of Position:
– Individual contributor and technical lead for development efforts involving ophthalmic equipment, accessory devices, and single-use pack devices.
– Involves organic hardware/accessory device design and collaboration with third-party design service providers.

Key Relationships:
– Internal: Commercial, Operations, Design Quality, R&D Project Management, Regulatory Affairs, Test Engineering.
– External: Surgeons/Key Opinion Leaders (KOLs), Nurses, Clinical Staff, Outside Technical Support Agencies.

Qualifications:
– Education: BS in Mechanical Engineering or Biomedical Engineering.
– Skills/Experience:
  – Proficiency in electro-mechanical design using SolidWorks, Autodesk Inventor, or similar software.
  – Ability to interpret and create engineering drawings, specifications, and reports.
  – Knowledge of electro-mechanical systems, devices, and materials, including pneumatic and fluidic management systems.
  – Broad knowledge of manufacturing methods, design, and tolerance analysis.
  – Exposure to instrumentation and test equipment/software.
  – Working knowledge of electrical systems and sensors.
  – Proficiency with MS Office tools, analytical tools, and ERP systems.
  – Excellent oral and written communication skills.

9604267