Jobs and Careers

Senior R&D Quality (Combination Product)

King of Prussia, United Statesfull_timeVerifiedPosted 9 Dec 2024

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. The Senior R&D Quality Engineer (Combination Product) position will be engaged in leading key aspects of Kymanox’s engineering service offerings and supporting clients on a portfolio of two to six projects covering a wide range of engineering and product maturity (from early concept to commercial), compliance, and commercialization challenges related to complex combination products (e.g., biologic-device, drug-device). Work under the guidance of management and with support of multiple experienced technical project managers. Work closely with clients and with cross functional teams including our Design & Innovation group in King of Prussia. Provide guidance on integrating quality considerations early in the device development process. Work closely with our software team when custom software is developed to support a client program. Support on site medical device manufacturing of clinical trial devices. Responsibilities:

Serves as the Quality functional lead on multiple client projects.
Reviews and/or approves technically complex documentation to ensure compliance with relevant standards and regulations.
Provide quality oversight for design controls and risk management.
Functional management and leadership of direct reports within team, if applicable.
Serves as the Quality functional lead on multiple client projects.
Reviews and/or approves technically complex documentation to ensure compliance with relevant standards and regulations.
Leads gap assessments against industry regulations or standards.
Participates in regulatory body inspections or remediation efforts.
Follows policies or standard operating procedures to support internal or client projects.
May support supply chain and vendor management strategy or compliance activities.
Provides technical project management and meeting facilitation.
Provide quality oversight for design verification activities, including protocol execution and method validation.
Completes assigned training requirements (internal and external).
Authors and reviews procedures, protocols, reports, and risk assessments related to product quality and safety.
Provide guidance on medical device test method validation approaches including study type and sample size.
Work with Design & Innovation to incorporate quality principles early in the medical device development phase.
Provide custom approaches for the level of documentation required based on the stage of the product.
Reviews and/or approves custom fixtures related to medical device testing and/or manufacturing.
Reviews and/or approves manufacturing related documentation.
Work within final assembly manufacturing environment(s) and assist in early-stage process development and manufacturing optimization to ensure products meet design intent.
Support early software development (SiMD) and appropriate level of documentation.
Support onsite medical device clinical trail manufacturing.
Completes assigned training requirements (internal and external).

Educational Background:

The ideal candidate will have a bachelor’s degree in Biomedical Engineering, Mechanical Engineering, Software Engineering or engineering-related field.

Experience: