Principal Engineer, Design & Innovation
Description
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 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. The 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.
Educational Background:
- The ideal candidate will have a bachelor’s degree in a science-related field such as Biomedical Engineering, Mechanical Engineering or Chemical Engineering.
Experience:
- Minimum of 10 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 11608 & 11040, as well as practical experience in the test methods described or referenced in those standards, a plus.
- Familiarity with metrology methods, experience in managing outside vendors for metrology and test execution.
Desired Aptitude and Skill Set:
- Provides immediate supervision and leadership of direct reports within team, if applicable.
- Act as technical lead on multiple projects.
- Design and prototype device systems and subsystems using CAD and common prototyping techniques.
- 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.
- 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.
- Participates in and supports a matrixed team environment with organization and detail-oriented initiatives.
- Author technical reports and presentations.
- Work within final assembly manufacturing environment(s) and assist in early-stage process development and manufacturing optimization to ensure products meet design intent.
- Communicate project progress and technical results to clients.
- Follows policies or standard operating procedures to support internal or client projects.
- Completes assigned training requirements (internal and external).
Travel:
Up to 20% travel is possible.
Career Development:
The position will evolve over time and more responsibilities may be added. Since Kymanox is a growing company, there are opportunities for advancement both within the currently defined role and in other functions within the organization.
Compensation:
Base salary is commensurate with experience, qualifications, and other intangibles evident during the interview process – as well as market conditions. Eligible for incentive program after 90 days of outstanding work.
Benefits:
Medical healthcare including dental and vision, short- and long-term disability, life insurance, matching 401(k) retirement plan, continuing education assistance, and other benefits.
About Kymanox:
Join Kymanox – a life sciences professional services company dedicated to life sciences who has successfully delivered over 4000 projects across 20+ countries. Become a member of a dynamic, fulfilling team that helps a broad range of life science products get to market more quickly, more affordably, and with the highest quality and safety standards possible in today’s biotechnology, pharmaceutical, medical device, and combination product industries. With a reputation of providing unparalleled professional services and our highly collaborative team of engineering, compliance, and project management experts, Kymanox provides an outstanding opportunity for learning and career advancement. Kymanox encourages team members, especially new graduates, and young professionals, to work on a variety of projects to gain increased learnings in Kymanox’s service offerings and the life science industry as a whole.
Kymanox is looking for motivated individuals who want to solve problems in the life science industries while doing the work they love and helping get modern medicines that enhance and save patient lives to market. Kymanox provides professional services related to engineering, compliance, and project management. We service clients ranging from Fortune 100 companies to virtual start-up companies. The company was founded in 2004 and has been growing steadily since its inception. Our corporate HQ is based in Research Triangle Park, NC, and we have offices in Boston, Chicago, Philadelphia, and New Jersey.
To learn more about our company, please visit our website: Life Science Solutions | Kymanox
Kymanox is an equal-opportunity employer and works diligently to protect the rights of job seekers by following all local, state, and federal laws as well as best Human Resource (HR) practices in the Life Science industry.