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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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Director of Operations

Ivyland, PA
General Summary

Responsible for leading high-quality facility and operations strategies meeting business objectives in the areas of Quality Control, Engineering, Production, Procurement, Shipping and Receiving.

Qualifications
  • Bachelor’s Degree in Engineering Operations, Supply Chain. Master’s Degree preferred.
  • Minimum ten years of experience in Manufacturing or Business Operations (preferable in the medical device industry).
  • Quality Assurance experience preferred. Certified Quality Engineer (CQE) preferred.
  • Experience with Kanban, Kaizen, 5S. Experience in quality, engineering, and manufacturing.
  • Experience with ISO 13485, FDA, and other international medical device regulatory requirements.
  • Conceptual, analytical, and computer skills.
  • Ability to work well with multiple instructions and projects.
  • Creative problem solver coupled with good judgement, independent work skills.
  • High attention to detail and accuracy.
  • Strong leadership and interpersonal communication skills with the ability to effectively communicate across all levels.
  • Presents professional manner and appearance.
Apply to function
Essential Functions
  • Mentor, direct, train, develop technical and management skills, supervise, and evaluate performance of leadership. Coaching by developing working relationship with company employees to drive continual improvement. Manage operations and commitment to a positive culture that focuses highly on customers’ needs. 
  • Maintain compliance with all aspects of current ISO 13485 and FDA quality system and regulatory requirements
  • Effectively elucidate quality system procedures and practices to both novices and experts.
  • Oversee new product development, legacy product sustainability, Design History Files, and 510(k) submission.
  • Structure, define and support all functions of engineering and build depth to accommodate for growth and high-performance.
  • Promote continuous improvement and make recommendations to streamline the project development process and production process.   
  • Oversee all functions of production and processes to streamline manufacturing, efficiency and control manufacturing costs.
  • Oversee procurement, supplier assurance contracts and auditing.
  • Ensure proper processes for shipping, receiving and movement of raw materials.
  • Work directly with the Regulatory Affairs and Quality Assurance management to support the company with a robust quality and regulatory system to ensure full compliance with the FDA QSRs, and cGMP.
  • Assist Regulatory Affairs in the area of complaint investigations to support potential MDR reporting. Analyze staffing requirements and responsibilities.
  • Promote cooperative and harmonious working climate which will be conducive to maximize employee morale, productivity, and efficiency/effectiveness amongst departments.
  • Actively promote and participate in cross-functional teamwork environment by managing and recommending continuous improvement processes.
  • Inform senior management fully on matters of significance and take prompt corrective action where necessary or suggest alternative courses of action.
  • Ensure a safe work environment, use of all proper PPE, operate consistent with OSHA, or other standards.
  • Establish key performance indicators, maintain, and report applicable department or organizational metrics.
  • Participate in cross-functional projects and project team meetings.
  • Developing and executing new growth directives
  • Working with the human resources department to create job descriptions, hire competent personnel and oversee employee training programs
  • Communicating with departmental heads to develop financial plans and ensure company-wide compliance
  • Monitoring company revenue margins and conducting budget reviews to maximize profits
  • Overseeing client support services

QA Coordinator

Ivyland, PA
General Summary

The Quality Assurance Coordinator is responsible for performing quality assurance activities as they relate to the manufacture, inspection, and distribution of products produced by the company.

Qualifications
  • High School Diploma, Associate Degree, or two or more years’ experience in a quality assurance/control position.
  • One year or more experience in the Quality Assurance/Control, Medical Device industry.
  • Preferred knowledge of Quality System standards and regulations including 21 CFR 820 and ISO 13485/14971.
  • Must be proficient in the use of a computer. Word and Excel knowledge required.
  • Attention to detail, strong in reading and comprehension.
  • Strong problem-solving skills.
  • Strong interpersonal and communicative skills.
  • Electronical and mechanical troubleshooting skills.
  • Technically inclined. Self-oriented, self-organized, and able to work with minimum supervision.
Apply to function
Essential Functions
  • Lead Quality Assurance activities needed to support manufacturing.
  • Review and approval of quality management system documentation as it relates to manufacturing of product(s) produced by the company.
  • Provide training to manufacturing personnel/groups regarding applicable quality and regulatory requirements relating to the manufacture of products produced by Wassenburg Medical, Inc.
  • Identifying, documenting, and processing of non-conforming product(s) identified in receiving inspection and manufacturing.
  • Must be able to communicate precisely and accurately to all levels of the organization.
  • Other duties as assigned by management

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.
Apply to function
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.

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, Computer Engineering, Industrial Automation, or related field.
  • Must have at minimum 3 years’ experience in software design and development.
Apply to function
Essential Functions
  • Must have knowledge and experience with object-oriented, back-end programming languages (Java, .NET, C#, etc.)
  • Must be analytical, have good problem-solving skills, and work in a well-organized and structured manner
  • Must be communicative, congenial, and flexible
  • Must have good command of the English language, spoken and written
  • 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 assigned by management
  • Knowledge and experience with the use and configuration of DevOps tools is an advantage
  • Previous experience in the design of FDA regulated medical device software systems is an advantage

Regulatory Affairs Specialist

Ivyland, PA
General Summary

Plans, directs, or coordinates regulatory activities of the organization to ensure compliance with regulations and standard operating procedures. Additionally, Regulatory Affairs prepares and files product submissions, product licenses, and establishment registrations.

Qualifications
  • Bachelor’s degree or equivalent, as well as 3 or more years’ experience as a Regulatory Affairs Specialist within the medical device industry. Preferably, RAPS certification (Medical Devices).
  • Working knowledge of and practice with FDA QSR’s (e.g. 21 CFR Parts 803, 810, 820, Part 11, etc.) and Guidance Documents.
  • Working knowledge of and practice with ISO 13485, FDA Databases, GUDID Database, FDA eSubmission Process – (510k, Adverse Events), Health Canada Problem Reporting (Preferrable), Q-Submission Program, HIBCC and GUDID.
  • Ability to communicate clearly and concisely, both orally and in writing.
  • Self-oriented, self-organized, and able to work with minimum supervision.
  • Proficient in the use of a computer: Visio, Access, Word, Excel and Power Point knowledge required.
Apply to function
Essential Functions
  • Develops regulatory strategy and implements plans for the preparation and submission of new products and 510(k) submissions.
  • Prepares and submits regulatory agency establishment registrations, user fees, applications, submissions, licenses, reports, device listings or correspondence.
  • Provides responses to regulatory agencies regarding product information or issues.
  • Schedules and facilitates Q-Submission Meetings with FDA. Completes meeting notes.
  • Maintains current knowledge of relevant regulations including proposed and final rules.
  • Manages activities of product recalls and medical device reports.
  • Provides regulatory guidance to departments or project development teams.
  • Reviews and approves product labeling to ensure that regulatory requirements are met.
  • Supports various quality functions for compliance with Quality System Regulation (QSR).
  • Supports the risk management program.
  • Oversees documentation efforts to ensure compliance with domestic and international regulations and standards.
  • Maintains regulatory agency updates concerning electronic submissions.
  • Communicates regulatory information to multiple departments and ensures that the information is interpreted accurately.
  • Familiarity with Medical Device requirements for Health Canada.
  • Other duties as assigned by management.

Accounting Assistant

Newtown, PA
General Summary

The Accounting Assistant is responsible for working in the Accounting Department on required daily tasks. The candidate must possess professional and communication skills, knowledge of accounting principles, and attention to detail. Looking for Full-Time or Part-Time for approximately 25 hours per week.

Qualifications
  • Bachelor’s Degree in Finance, Accounting, or equivalent and/or 1-2 years of experience in a related field required.
  • Knowledge of prepaid expenses and accrual accounting.
  • Sage 100 (or other ERP system) knowledge preferred.
Apply to function
Essential Functions
  • Accounts Receivable – Manage accounts receivable including collections, queries, and entering accounts receivable billing information in accounting software
  • Accounts Payable – Assist with accounts payable including vendor payment and invoice management approval
  • Creating invoices, credit memos and statements and distributing them to customers.
  • Review all corporate card transactions to ensure proper coding and processing
  • Participate in the end of month close procedures
  • Other Duties as Assigned

QA Coordinator

Ivyland, PA
General Summary

The Quality Assurance Coordinator is responsible for performing quality assurance activities as they relate to the manufacture, inspection, and distribution of products produced by the company.

Qualifications
  • High School Diploma, Associate Degree, or two or more years’ experience in a quality assurance/control position.
  • One year or more experience in the Quality Assurance/Control, Medical Device industry.
  • Preferred knowledge of Quality System standards and regulations including 21 CFR 820 and ISO 13485/14971.
  • Must be proficient in the use of a computer. Word and Excel knowledge required.
  • Attention to detail, strong in reading and comprehension.
  • Strong problem-solving skills.
  • Strong interpersonal and communicative skills.
  • Electronical and mechanical troubleshooting skills.
  • Technically inclined. Self-oriented, self-organized, and able to work with minimum supervision.
Apply to function
Essential Functions
  • Lead Quality Assurance activities needed to support manufacturing.
  • Review and approval of quality management system documentation as it relates to manufacturing of product(s) produced by the company.
  • Provide training to manufacturing personnel/groups regarding applicable quality and regulatory requirements relating to the manufacture of products produced by Wassenburg Medical, Inc.
  • Identifying, documenting, and processing of non-conforming product(s) identified in receiving inspection and manufacturing.
  • Must be able to communicate precisely and accurately to all levels of the organization.
  • Other duties as assigned by management

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.
Apply to function
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.

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, Computer Engineering, Industrial Automation, or related field.
  • Must have at minimum 3 years’ experience in software design and development.
Apply to function
Essential Functions
  • Must have knowledge and experience with object-oriented, back-end programming languages (Java, .NET, C#, etc.)
  • Must be analytical, have good problem-solving skills, and work in a well-organized and structured manner
  • Must be communicative, congenial, and flexible
  • Must have good command of the English language, spoken and written
  • 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 assigned by management
  • Knowledge and experience with the use and configuration of DevOps tools is an advantage
  • Previous experience in the design of FDA regulated medical device software systems is an advantage

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.
Apply to function
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

Production Technician

Ivyland, PA
General Summary

A Production Technician assembles parts to create large or heavy sub-assemblies and complete devices. The technician evaluates these parts to ensure that they meet specifications. The 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.
Apply to function
Essential Functions
  • Assembles fabricated parts to large or heavy subassemblies and complete devices.
  • Test and calibrates parts and mechanisms to meet tolerances and product specifications as directed by management.
  • Follows 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 task of equipment the production area/department.
  • Complete required maintenance forms promptly as required.
  • Identify and report all problems/potential problems (Non-Conforming Product) to manager
  • Communicate effectively verbally and in writing
  • Exercise courtesy and tact when dealing with others
  • Exercise sound judgment when: evaluating situations, offering positive suggestions, and making decisions
  • Maintain acceptable attendance/punctuality standards
  • Maintain quality and quantity work standards
  • The safe and efficient use and operation of equipment, tools, machines, and vehicles
  • Clarification/understanding of procedures and instructions
  • Respond to inquiries and/or complaints in a timely and professional manner
  • Work in coordination and collaboration with others
  • Exhibit honesty and a supportive attitude
  • Able to accurately read and use tape measure
  • Performs other duties and task as assigned by their supervisor/ manager.