Principal Medical Device Engineer

Kymanox (King of Prussia PA, USA) 28 days ago
Full-time

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:

  • 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.
  • 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.
  • Support testing function and oversee test method development.

Desired Aptitude and Skillset:

  • 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.

Educational Background:

Bachelor of Science in Science in a related discipline or Engineering from an accredited institution.

Experience:

  • 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 combination products, design controls, and ISTA standards and the application to pharma & medical device products.
  • 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 or Jump for data analysis, experiment design, and tolerance interval calculations.
  • 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.
  • Proficiency in solid modeling, preferable 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.
  • 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 metrology methods, experience in managing outside vendors for metrology and test execution.

About Neuma, a Kymanox company:

Founded in 2017, Neuma LLC is an engineering services firm based in King of Prussia, PA, focused on rigorous design, development, and testing of novel medical technologies to rapidly evolve prototypes to products. Neuma leverages lean resourcing, intensive Design for Excellence (DFX) principles, and integrates system thinking into product development to transform early-stage technologies into commercial medical solutions.


Principal Medical Device Engineer

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