Jobs and Careers

Medical Device Test Engineering Lead

King of Prussia, United Statesfull_timeVerifiedPosted 4 Jun 2025

About the role

Is Kymanox the right fit for you? You want to make a difference and have an impact… You enjoy having an influence in your day-to-day work… You are motivated by working alongside a team filled with subject matter experts who will help you learn and grow… You wake up every day and do what you do … because patients deserve better. If this sounds like you, you’ve come to the right place. Responsibilities: Job Description:This position is responsible for the strategic oversight and coordination of GxP and non-GxP projects at the Kymanox medical device and combination product testing laboratory, with specific focus in physical test method development and validation, as well as design verification planning. This position is based at the Kymanox site in King of Prussia, Pennsylvania and requires presence on site (≥3 days/week). Responsibilities include (but are not limited to):

Collaborate with project-specific project managers and technical leads to coordinate laboratory activities in support of test method development, test method validation, and ensure design verification readiness.
Support development, documentation, and qualification of test fixtures.
Oversee test method development, planning and execution of test method validations, method documentation, and sample management
Specify, purchase, and qualify equipment necessary to augment capacity and capabilities to support future testing needs
Serve as liaison with sales, clients, and project teams to ensure projects are aligned with laboratory capabilities and resources
Manage and coordinate personnel and equipment resources to support testing activities based on project timelines
Work with Quality to ensure compliance with Quality Management System including managing and evaluating deviations and coordinating testing document reviews.
Establish best practices for testing to ensure efficiency during testing and delivery of high-quality testing data
Develop and deliver strategic initiatives for improving lab and testing functionality and efficiency
Work with testing services to build and maintain laboratory master schedule
Review and approve testing documentation including testing plans, method validation protocols and reports, and testing reports.
Support statistical analysis and act as Data Reviewer of data collected during testing.
Creating and/or updating applicable Standard Operating Procedures that govern laboratory workflows.
Manage 3-5 laboratory engineers/operators as direct reports.

Educational Background:

Minimum of Bachelor’s degree in scientific, engineering, or other technical discipline from an accredited institution or equivalent.

Experience:

5+ years of experience in testing of medical devices, combination products, pharmaceuticals, and/or biotech/biologics is required.
5+ years of experience in developing and validating functional test methods. Experience designing, executing, and analyzing test method validation studies is required.
1+ years of project management experience preferred.
2+ years of personnel management experience preferred.
Familiarity with GxP requirements, FDA/ICH guidance, ISO standards, and USP is required.
Experience working hands-on in a laboratory setting is required.
Specific experience with Design Verification activities is preferred.
Experience using Minitab statistical software for method validation and data analysis is preferred.
Experience working as a service provider is preferred.

Desired Aptitude and Skill Set:

Highly organized and excellent attention to detail
Ability to follow-up on assignments without reminders
Strong analytical skills
Fast learner and adaptable to change
Ability to work with cross-functional teams, both within Kymanox and with clients or suppliers
Strong planning and management skills
Adept at proactive and creative problem so