Job description

Job Title: R&D Engineer

Department: Research & Development

Reports To: Director Research & Development

Location: 144 Railroad Drive Ivyland PA, 18974

General Summary:

The R&D Engineer must perform electro-mechanical design, development, and testing functions for Class 2 medical devices throughout the entire product lifecycle in accordance with established design control and risk management procedures. Also responsible for the planning, design, execution, and documentation of V&V testing activities in support of new product introductions and changes to existing products.

Essential Functions:

• Implementation of design control and risk management procedures and conformance to all relevant industry standards and government regulations
• Work with cross functional team (CFT) to develop design and development plans, verification and validation plans, and risk management plans
• Work with CFT to develop and/or review product requirements and design specifications
• Plan and execute design verification and validation (V&V) testing of medical devices and their sub-systems. Maintain an up-to-date knowledge of validation requirements, practices, and procedures
• Interact with cross-functional group of stakeholders to facilitate project implementation
• Conduct design review meetings
• Transfer medical device designs to manufacturing
• 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 task 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 related engineering field, or 7 years’ practical experience in related engineering field.

Practical Experience:

Ability to work well under pressure and to meet multiple and occasionally competing deadlines while maintaining a cooperative working relationship with other employees and management.

Proficient in the use of a computer aided design program(s), Microsoft Word and Excel knowledge required. Basic understanding of computer operating systems, 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 emphasis.

Job Type: Full-time

Schedule: 8-hour shift, Monday to Friday

Work Location: One location

Job Type: Full-time

Schedule:

• 8 hour shift
• Monday to Friday

Application Question(s):

• What is your salary requirement?

Education:

• Associate (Preferred)

Experience:

• related: 1 year (Preferred)

Work Location: In person

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