(Contract) Senior/Principal R&D Engineer, Design & Innovation

• 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 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.

• 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).

Kymanox