Research and Development Engineer

Job Title: Engineer
Department: Research & Development
Reports To: Engineering Supervisor
Location: 144 Railroad Drive, Ivyland PA, 18974

General Summary:
The Engineer must perform electro-mechanical design and development functions for Class I and Class 2 medical devices throughout the entire product lifecycle in accordance with established design control and risk management procedures, design and execute verification and validation plans, execute engineering change oprders, and develop and maintain risk management and design history files.

Essential Functions:

• Implementation of design control and risk management procedures.
• Work with cross functional team (CFT) to develop design and development plans, verification and validation plans, and risk management plans.
• Work with CFT to define and/or review requirements and design specifications.
• Plan and execute design verification and validation (V&V) testing of medical devices and their sub-systems.
• Conduct design review meetings.
• Develop and maintain risk management files (RMF) and design history files (DHF).
• Facilitate the execution of design changes and engineering change orders (ECO).
• Perform other duties and tasks as assigned by their supervisor/manager.
• Strong interpersonal and communicative skills.
• Strong problem solving skills.
• Knowledge of washer/disinfector design is an advantage.
• Project management skills and experience is an advantage.

Education Required:
Must have a BS and 3 years’ experience in a related engineering field, an AS and 5 years’ experience in a related engineering field, or 7 years’ of practical experience in a related engineering field.

Practical Experience:
Proficient in the use of computer aided design program(s), Microsoft Word and Excel knowledge required. Basic understanding of computer operating system, file structure, network setup, etc. required.

Aptitude Required:

• Mental: Constantly
• Mechanical: Occasionally
• Verbal: Frequently
• Personal Initiative: Very Important

Physical Requirements:

• Standing: Occasionally
• Walking: Occasionally
• Sitting: Constantly
• Bending/Stooping/Squatting: Occasionally
• Climb Stairs: Rarely
• Lying Down: Rarely
• Push or Pull: Occasionally
• Reach Above Shoulders: Rarely
• Climb Ladders: Rarely
• Grasp/Grip: Occasionally
• Finger Dexterity: Occasionally
• Writing/Typing: Constantly
• Driving/Operating Equipment: Rarely
• Vision (Beyond Arms Length): Rarely
• Lifting/Carrying:
  • Over 150 lbs: Rarely
  • 76 – 150 lbs: Rarely
  • 51 – 75 lbs: Rarely
  • 26 – 50 lbs: Rarely
  • 10 – 25 lbs: Occasionally
  • 1 – 9 lbs: Occasionally

Environment:

• Hearing Requirements: Frequently
• Speaking Requirements: Frequently
• Working Indoors: Constantly
• Working Outdoors: Rarely
• Working in Confined Space: Rarely
• Exposure to Fumes, Chemicals, Solvents, Caustics, etc: Occasionally
• Extreme Temperatures: Rarely
• Eye/Hand/Foot Coordination: Occasionally

Reasoning Development:
Apply principles of logical or scientific thinking to define problems, collect data, establish facts, and draw valid conclusions. Interpret an extensive variety of technical instructions in mathematical or diagrammatic form. Deal with several abstract and concrete variables.

Mathematics: Algebra, Calculus, Statistics

Language Development:
Reading: Read novels, tech journals, and blueprints with understanding.
Writing: Prepare business letters, expositions, summaries, and reports with proper format.
Speaking: Speak clearly and distinctly with appropriate pauses and e