Engineer I, Product Development

Enable Injections Inc. • Sharonville, OH

2d • Onsite

About The Position

This role supports the design and development of medical devices, ensuring adherence to company procedures, industry regulations, and customer requirements. The position involves applying mechanical engineering principles to solve challenges in product design, manufacturing, assembly, and testing. Key responsibilities include contributing to product specifications, drawings, test protocols, and reports, as well as converting user needs into actionable inputs and supporting verification and validation strategies. The role also involves risk management activities, generating design history files according to FDA and international standards, supporting manufacturing process development, and providing project status updates to leadership.

Requirements

• Bachelor's degree or higher in Mechanical Engineering, Biomedical Engineering, or related field from an accredited university
• Understanding in mechanical design fundamentals and solid modeling.
• 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 to change and handle unexpected situations with close guidance
• Accepts direction on how to adapt approach to changing situations
• Ability to follow defined procedures
• Ability to stay focused on tasks, organize, compare, interpret basic data, and assess problems with guidance
• Work to acquire and develop new skills
• Ability to collaborate and maintain cooperative work relationships with others
• Engage colleagues with the Enable Values in mind
• Ability to maintain a positive attitude, show empathy for others, and always do the right thing
• Good time management skills

Nice To Haves

• Co-op/internship experience in product design
• Training/proficiency in CAD software, especially SolidWorks

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, supports the development of verification and validation strategies, and conducts risk management activities
• Generate design history files following FDA and international standards
• Support manufacturing process development
• Provide project status to leadership

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level