Jobs and Careers
KY
(Contract) Senior/Principal R&D Medical Device Engineer - Project Based
KymanoxKing of Prussia, United Statesfull_timeVerifiedPosted 6 Nov 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: The (Contract) Senior/Principal Engineer, Design & Innovation will work alongside a cross functional team to support our customers in the design and development of next generation medical devices and combination products. This engineer will design, develop, prototype, and test cutting edge technologies while interfacing with other engineers from mechanical, electrical, firmware, and quality functions. Please note that this position will be project based and full-time hours are not guaranteed.The Senior/Principal Engineer will:
- Provides immediate supervision and leadership of direct reports within team, if applicable.
- Interface with clients and project leads on tasks as a technical lead.
- Design and prototype device systems and subsystems using CAD and common prototyping techniques such as 3d printing or machining.
- Perform analytical assessments to inform design directions as needed.
- Create test plans including test design and determine whether they can be run in-house or need to be outsourced.
- Support testing function and oversee test method development.
- Aggregate, analyze, and report on test data and provide feedback to the design team.
- Identify and mitigate risks associated with device functionality, reliability, safety, COGs and manufacturing scalability.
- Work with cross-functional teams within the organization.
- Work within final assembly manufacturing environment(s) and assist in early-stage process development and manufacturing optimization to ensure products meet design intent.
- Work with and manage external suppliers, conduct DFM reviews, and go onsite as needed.
- Conduct technology tear-down studies.
- Design and setup feasibility tests.
- Develop failure analysis models using simulation tools.
- Periodically participate in strategic planning activities.
- Mentor other engineering team members within the organization.
- The ideal candidate will have a bachelor’s degree in a science-related field such as Biomedical Engineering, Mechanical Engineering or Chemical Engineering.
- Minimum of 10-15 years of experience within a product development environment is required, preferably with class II or III medical devices.
- Experience in product design for high volume manufacture.
- Strong leadership and project management skills with proven track record within testing and validation.
- Experience working within New Product Development is required.
- Knowledge of design controls.
- Experience in the design of disposable, bio-compatible fluid paths and/or container solutions, a strong plus.
- A track record of generating novel ideas / IP, a strong plus.
- Proficiency utilizing MS Office Suite (Word, PowerPoint and Excel etc.), and statistical software tools such as Minitab for data analysis, experiment design, and tolerance interval calculations.
- Proficiency in solid modeling, preferably with SolidWorks, for the modeling of device components and basic fixtures for test execution; further preference for experience in developing and/or reviewing 2D drawings for fixture components and/or assemblies.
- Proficiency with Matlab or Python, a strong plus.
- Experience with the execution and development of methods for Universal Testing Machines including programming custom test routines.
- Practical experience in the customization of a standard test procedure to a novel product, including test method feasibility development, Gauge R&R evaluation, and pre-validation assessment.
- Familiarity with the core standards of drug delivery devices, such as ISO
Apply for this role
Generate a tailored application kit with a matched cover letter, interview prep, and CV highlights — in under 60 seconds.
Apply Now →Generate Application KitFree account required — sign up in 30s