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Location: Onsite
Status Type: Full Time
QUALIFICATIONS
Required:
- Bachelor's degree or higher in Mechanical Engineering, Biomedical Engineering, or related field from an accredited university
- A minimum of 4 years of product development experience; OR a master’s degree in a related field plus 2 years’ experience
Preferred:
- Experience in development and/or manufacturing of medical devices
- Experience with plastic injection-molded part design
- Proficiency in SolidWorks
- Understanding of Geometric Dimensioning and Tolerancing (GD&T)
Skills & Competencies:
- Proficiency in mechanical design fundamentals, solid modeling, tolerance stack analysis, and design for manufacturing
- Proficiency utilizing the MS Office Suite (Project, Word, Excel, PowerPoint, Visio, Outlook).
- Strong analytical and creative problem-solving skills
- Excellent verbal communication and technical writing skills
- Ability to adapt behaviors and activities during times of change and handle unexpected situations with little to no guidance
- Exemplifies flexibility and resourcefulness; responds deftly to a variety of challenges and situations
- Ability to understand complexity, anticipate problems, and proactively diagnose
- Plan and carry out sequential projects
- Ability to analyze problems and troubleshoot solutions
- Apply solid cognitive ability to collecting, processing, and disseminating information
- Begin to demonstrate the ability to foster teamwork, collaboration, negotiation, and influencing others
- Engages colleagues with the Enable Values in mind
- Ability to maintain a positive attitude, show empathy for others, and always do the right thing
- Ability to understand your own emotions and their effects on your performance
- Ability to have a positive impact on others in support of company goals and a healthy work environment
- Excellent time management skills
Physical Requirements:
- Must be able to remain in a stationary position for extended periods of time
- Ability to constantly operate a computer and other office equipment, such as printer, telephone, etc.
- Position requires being physically present on the premises during regular company hours or as approved by management
RESPONSIBILITIES:
- Support the design and development of medical devices that adhere to company procedures, industry regulations and customer requirements
- Understand and follow the New Product Design process with a focus on quality
- Apply mechanical engineering principles and techniques to solve challenges related to product design, manufacturing, assembly, and testing
- Contribute to the development of product specifications, drawings, test protocols and reports.
- Convert user needs to input, develop verification and validation strategies, and conduct risk management activities
- Support manufacturing process development
- Generate design history files following FDA and international standards
- Identify project risks and develop mitigation strategies
- May provide technical guidance and coaching of other engineers
- Provide project status to leadership
- Contributes to internal project planning and execution to meet schedule and budget requirements
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