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Careers
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.
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.
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
Production Technician
Ivyland, PA
General Summary
The Production Technician assembles parts to create large or heavy sub-assemblies and complete devices. The Production Technician evaluates these parts to ensure that they meet specifications. The Production Technician performs preventative maintenance on equipment. Manufacturing quality products according to established company procedures and job specific instructions is the responsibility of the Production Technician.
Qualifications
- High School Diploma or equivalent and/or 5 years’ experience, as well as 3 or more years’ experience in a related field.
- Must be proficient in the use of a computer.
- 1 to 3 years’ experience preferred using power tools: table saw, band saw, router, grinder, drills, circular saw, contact adhesives, power sanders, heat gun, and soldering iron.
- MIG Welding experience preferred but not required.
Essential Functions
- Assemble fabricated parts to large or heavy subassemblies and complete devices.
- Test and calibrate parts and mechanisms to meet tolerances and product specifications as directed by management.
- Follow established procedures and guidelines to manufacture the organization’s products according to production specifications and schedules, volume, cost, and wastage targets or quality standards.
- Perform preventive maintenance of equipment in the production area/department.
- Complete required maintenance forms promptly as required.
- Identify and report all problems/potential problems (Non-Conforming Product) to Production Manager.
- Exercise courtesy and tact when dealing with others
- Exercise sound judgment when: evaluating situations, offering positive suggestions, and making decisions.
- Performs other duties and task as assigned by their supervisor/ manager.
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.
- 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
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.