Engineer II - Sustaining
About The Position
The R&D Sustaining Engineering team is seeking a talented and passionate individual to help us be the guardian of product performance, quality, and compliance throughout our products lifecycle. This position will collaborate closely with cross-functional teams -R&D, Quality, Regulatory, Marketing, MA and Manufacturing- to troubleshoot issues, implement design changes, and support continuous improvement initiatives. Our R&D Engineers are responsible for developing and implementing new product designs, product improvements, and critical component changes for disposable and durable medical devices. This role will be predominantly working in the sustaining aspect and less with New product development (NPD).
Requirements
- Bachelor's Degree in S.T.E.M or related field
- 2 to 5+ years of professional experience in product engineering
- Basic understanding of applicable standards and regulations (e.g., FDA 21 CFR 820, ISO 13485, IEC 60601), including design controls, risk management, and documentation.
- Experience developing protocols, test methods, statistical analysis, and test report generation
- Experience gained in a classroom and/or internship or Co-op setting
Nice To Haves
- Master’s degree in S.T.E.M
- Experience designing, analyzing, and troubleshooting systems that combine mechanical components, electronics, sensors, and software
- Experience in medical devices or another highly regulated manufacturing environment.
- Experience in or interest in a Sustaining role
Responsibilities
- Participates in the documentation of sustainability and product development risk activities and design controls
- Applies engineering principles to solve basic engineering problems
- Authors a requirements document for a subsystem or simple component or a section of a requirements document for a larger system
- Reports to manager on progress on tasks that were assigned to them; completes management updates as requested by manager
- Correctly selects and applies analytical methods to interpret small, well characterized data sets; Able to extract key information and its relative importance from data sets; Able to define conclusions from the data set and present the conclusions logically and in an understandable way for technical individuals
- Actively participates in team meetings, makes recommendations, accepts commitments, and delivers commitments
- Interacts with product managers and more experienced engineers to understand the business aspects of product development
- Is a Participant and contributes on project teams where technical issues and product development challenges had driven unique solutions
Benefits
- face-to-face collaboration supports your learning, your progress, and your success
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
