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Wassenberg Medical, Inc. is a growing Medical Device manufacturing company. Our home office is located in Ivyland, Pennsylvania. We strive to design, develop, and produce products and provide services of superior quality and function that benefit our customers and assure patient care.

Wassenberg Medical, Inc. offers both part-time and full-time employment. Our full-time employees are offered a rich benefit package including health insurance, dental insurance, vision insurance, disability insurance, 401k, and paid time off. Our current open positions can be found below. This page will be updated when new positions become available.

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Software Engineer

Ivyland, PA
General Summary

The Software Engineer position will be focused on the design and development of new and existing software for medical devices and the maintenance of the software throughout its full lifecycle. The position is responsible for writing technical documentation and working within a Quality Management System customary in the medical device industry.

Qualifications
  • Must have a BS in Software Engineering, Computer Science, or Computer Engineering.
  • Must have at minimum 3 years’ experience in software design and development.
  • Previous experience in the design of FDA regulated medical device software systems is an advantage.
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Essential Functions
  • Must have knowledge and experience with object-oriented, back-end programming languages (Java, VB.NET, C#, etc.)
  • Database management using SQL server software
  • Experience with Windows 10 configuration, including Group Policy, security settings, and application management
  • Knowledge of scripting languages such as PowerShell for automation tasks related to both SQL Server and Windows 1
  • Must be analytical, have good problem solving skills, and work in a well-organized and structured manner
  • Develop and maintain device software design history files
  • Conduct post market cybersecurity threat assessments
  • Respond to and remediate security incidents, including data breaches and unauthorized access
  • Must be able to work within cross functional teams to create requirements, specifications, designs, test plans, etc. to ensure that software safely satisfies user requirements
  • Perform other duties and tasks as assigned by management

R&D Engineer

Ivyland, PA
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.

Qualifications
  • 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.
  • 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.
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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

Device Testing Technician

Ivyland, PA
General Summary

The Device Testing Technician plans, executes, records, and analyzes data, and drafts test protocols and reports for a variety of medical devices. The Device Testing Technician works with endoscope manufacturers to obtain and receive endoscopes and pertinent information required for evaluation. Under the supervision of the Research and Development Department, the Device Testing Technician works collaboratively with Customer Training, Quality Assurance, Regulatory Affairs, and other departments to prioritize, coordinate, and schedule the cross functional evaluation of new endoscope models and develop their application within Wassenburg Medical devices. The Device Testing Technician records data from testing and evaluation in standard formats and provides results in the form of spreadsheets, diagrams, charts, forms and reports to other functional departments for review and approval.

Qualifications
  • Requires on the job training, 1-3 years’ experience in a related field preferred.
  • Must be well organized, flexible, and able to work independently with minimum direct supervision performing both routine and complex tasks.
  • Must have strong verbal and written communication skills.
  • Must have strong problem solving skills.
  • Punctual, regular, and consistent attendance.
  • Must be technically inclined.
  • Proficient in the use of computers, Word, and Excel.
  • Understanding of computer operating system, file structure, network setup, etc.
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Essential Functions
  • Work within an ISO 13485 and FDA compliant Quality System.
  • Communicate internally and externally to develop an understanding of testing needs and objectives.
  • Proactively coordinate, organize, and schedule appropriate testing.
  • Follow approved test protocols, perform (as applicable) verification and validation activities, document and complete analysis of the testing performed.
  • Use various calibrated tools and instruments utilized for measuring and monitoring (Multimeter, Oscilloscope, Caliper, etc.).
  • Use and maintain test equipment.
  • Develop, maintain, and organize test data files containing applicable testing and other applicable information.
  • Work within or in charge of a cross functional team.
  • Draft test reports for inter-departmental review and approval.
  • Work with Manufacturing and Engineering in support of process and product changes.
  • Read schematics, assembly drawings, data sheets, etc.
  • Perform other duties and tasks as assigned by management.