Senior Engineer, Design and Innovation
Kymanox
- King of Prussia, PA
- Permanent
- Full-time
- 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.