Job Description
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.
Job Responsibilities
- 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.
Numbers & Facts
| Location | Warminster, PA |
| Job Type | Full-time |
| Company Size | 11 - 50 |
| Headquarters | Warminster, PA, US |
| Website | https://www.wassenburgmedicalinc.com |
Qualifications
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.
Skills:
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. Strong interpersonal and communicative skills required. Strong problem solving skills required. Knowledge of washer/disinfector design is an advantage. Project management skills and experience is an advantage.
Benefits
Paid Time-Off, 401K Match, Paid Sick Days, 401K, Medical, Dental, Vision
About Company
About Us
Wassenburg Medical is a world leader in delivering excellent endoscope reprocessing products and solutions. Established in 1984 by Gerrit Wassenburg, the business has developed from a family company into a global player and is expert in all aspects related to automated endoscope reprocessing. Wassenburg Medical has been a member of the HOYA corporation since 2013.
Wassenburg solutions are designed to deliver a safe and controlled treatment of flexible endoscopes. Our end-to-end total solution includes pre-cleaning, washing and disinfection, storage, transport and traceability.
Since its establishment, Wassenburg has grown exponentially. With headquarters in the Netherlands, sales offices in the UK, Ireland, Belgium, France, Germany, United States and an exclusive distributors network in Europe, Middle East, Australia, New Zealand and Africa. Wassenburg Medical is expanding its global footprint rapidly.
Our Mission
Our ultimate goal is infection-free patient treatment and a safe, user friendly, efficient and innovative endoscope reprocessing process at every hospital or clinic.
We put safety, quality, care and respect for people and the environment first in everything we do.
Markets Served
Any healthcare setting including but not limited to hospitals, medical centers, outpatient clinics, ambulatory surgery centers, physician offices, etc. Where endoscopy procedures are performed and endoscopic instrumentation require effective cleaning and high-level disinfection.
Skills
- Documentationunmatched
- Electromechanical Designunmatched
- Electromechanical Engineeringunmatched
- Medical Equipmentunmatched
- Product Lifecycleunmatched
- Product Supportunmatched
- Product/Service Launchunmatched
- Research & Development (R&D)unmatched
- Risk Managementunmatched
- Test Plan/Scheduleunmatched
- V&V Testingunmatched
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