Job DescriptionPosition Summary The Product Design Engineer III position in the Vascular Access Product Design Engineering team will have the opportunity to create impactful solutions for the medical field while collaborating with Product Development Engineers, Systems Engineers, R&D Testing Labs, Marketing, Design Assurance, as well as internal and external Manufacturing teams.
The primary focus of this role will be supporting the development and design verification of medical device components and products of varying complexity. The engineer will require the ability to organize and run engineering studies, interest in running product design and technology focused research, the ability to run competitive product and characterization studies, and the ability to run design verification and product qualification on medium to large scope projects. The engineer is responsible for developing and implementing new products through adherence to established design control processes and good engineering and documentation practices. The position plays a key role in assisting in the development and compliance challenges involved with new medical devices. Familiarity with Minitab and SolidWorks, or comparable statistics and CAD software, is a plus.
Essential Duties & Responsibilities - Organizes and executes engineering studies of medium to large complexity
- Conducts product design and technology focused research
- Runs competitive product and characterization studies
- Organizes, plans, and executes formal design verification activities for medium to large scale new product introduction projects. Supports similar activities for other projects of varying scale.
- Writes test protocols, performs test method validations and executes test plans, and authors test reports with data analysis and technical conclusions.
- Supports risk management activities through hazard analysis and design failure and effects analysis (DFMEA) and the identification and implementation of risk mitigation.
- Supports the analysis and evaluation of solutions to complex problems. Conducts investigations of varying complexity pertaining to the development of new designs, methods, materials or processes, and investigates possible applications of the results.
- Assists in the development of products from concept to production
- Adheres to established design control processes and good engineering practices
- Designs and models components, devices, test fixtures, prototype/pilot tooling for various product lines using SolidWorks
- Supports the technical foundation for the development of risk documentation
- Develops test procedures to ensure specifications and regulations are met
- Executes engineering and validation studies on products
- Work on special projects as assigned
Knowledge & Skills - Detail oriented and ability to organize large amounts of work and data
- Strong interpersonal skills required in the areas of verbal and written communications, customer focus, time management, professionalism, and team building
- Excellent project leadership and ability to expedite project completion
- SolidWorks competency preferred
- Minitab or similar statistics competency preferred
- Understanding of engineering mechanics and physics
- Familiarity with machine shop practices
- Familiarity of drafting standards
Minimum Qualifications, Education & Experience - Must be at least 18 years of age
- Bachelor of Science degree from an accredited college or university in Mechanical Engineering or a related field. Master's Degree preferred.
- 4-7 years of experience in Medical Device Product Development
Work Environment - This is largely a sedentary role.
- This job operates in a professional office environment and routinely uses standard office equipment.
- Typically requires travel less than 5% of the time
