- 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.
- Ethical, responsible, and data-driven decision-maker
- Expertise in the design and manufacture of plastic, rubber, and metal components
- Strong understanding of material science as it pertains to polymers, metals and glass
- Flexible and versatile
- Self-directing, self-pacing, fast learner.
- Strong verbal/written communication skills
- Ability to prioritize work in a fast-paced, dynamic environment
- Excellent problem-solving skills and results oriented.
- Solid team player
- Ability to translate product design requirements into specifications that can be tested against methods that can be validated
- Familiarity with Statistical Process Control (SPC), GD&T; Lean, Six Sigma knowledge, a plus
- Design for manufacturing (DFM). Automated assembly experience, a plus.
- PC skills - MS Office Suite, SolidWorks required.
- Minimum of 5 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.
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Senior Engineer, Design and Innovation - King of Prussia, United States - Kymanox
Description
Position at Kymanox
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 that 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.
Kymanox is growing and looking for an experienced Engineer to join our team in our King of Prussia location
Job Responsibilities:
The Senior Engineer 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 Senior Engineer will:
Bachelor of Science in Science in a related discipline or Engineering from an accredited institution.
Experience:
Kymanox ('ki-mah-noks'), meaning Ideal Knowledge Transfer , advances life science innovation through insightful solutions and collaboration. We do this by accelerating the design and commercialization of modern medicines for our customers using integrated engineering, scientific, compliance, and project management solutions that are insightful, collaborative, and comprehensive.
By building and supporting the development of modern medicines, Kymanox has proven, end-to-end solutions that are helping bring better Life Science Products to the market- and keep it there. We do all of this with heart and pridebecause patients deserve better.
Kymanox, founded in 2004, serves clients from Fortune 100 companies to virtual start-up companies all across the globe. Headquartered in Research Triangle Park, NC, we have US offices in Boston and Philadelphia, and since 2022 have expanded to Germany, Switzerland, and Israel.
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.
