Development Engineer
- Interface with surgeons to gather input for designs and evaluation of new products
- With supervision, work with R&D, Quality, Manufacturing, Regulatory, Clinical, Marketing and Project Management to ensure project success
- With supervision, design, develop, modify, evaluate and verify mechanical components for medical devices
- Learn procedures, policies, processes, systems, and technology required
- Work on problems in limited scope; purposefully learn while gaining experience
- Demonstrate ownership and integrity of work
- Seek to establish collaborative relationships
- Participate in and support cadaver labs to evaluate designs and ensure user needs are met
- Interpret customer needs and understands design inputs
- Understand the product intended use and clinical procedures
- Understand fundamental industry standards, design requirements and test strategies which align with regulatory requirements
- With supervision, create or refine engineering documentation, such as the Design History file per company design control procedures
- Learn R&D procedures like design controls and risk management, per the Quality Management System
- Under supervision, design, develop, modify, and verify mechanical components for medical devices
- Assist with prototyping and bench testing
- Support problem solving, root cause analysis, identify potential solutions, and evaluate them against requirements.
- Under supervision, conduct research and studies to support product design
- Prepare and review information for invention disclosures and patent applications
- Participate in design reviews
- Bachelor of Science in Engineering, Mechanical Engineering, Biomedical or Masters in related discipline
- Co-Op or Internship experience preferred
- Up to 3 years of experience, medical device industry preferred
- Basic understanding of traditional and additive manufacturing processes
- Fundamental knowledge and understanding of mechanical engineering practices and tools, design principles within a regulated environment
- Basic experience with a parametric CAD package, (ProE, Creo, or Solidworks preferred)
- Basic knowledge of analysis tools and statistical methods
- Basic knowledge of materials and manufacturing methods
- Ability to read and Interpret complex drawings
- Receives a high level of supervision
- Responsible for tasks assigned by project leader
- Sets and manages priorities for self
- Comprehensive health, dental, and vision insurance
- 401(k) with company match
- Paid time off (PTO) and holidays
- Ongoing training and professional development opportunities
- Opportunity to grow within a fast-paced, dynamic company
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