Company:
Enable Injections Inc
Location: Cincinnati
Closing Date: 06/11/2024
Hours: Full Time
Type: Permanent
Job Requirements / Description
QUALIFICATIONS
Required:
Required:
- Bachelor's degree or higher in Mechanical Engineering, Biomedical Engineering, or related field from an accredited university.
- A minimum of 6 years of product development experience; OR a master's degree plus 4 years' experience.
- Experience in developing and commercializing regulated medical devices.
- Experience with plastic injection-molded part design.
- Proficiency in SolidWorks.
- Experience with designing for large scale automation.
- Experience with Schedule development.
- Proficiency in mechanical design fundamentals, solid modeling, tolerance stack analysis, design for manufacturing, Geometric Dimensioning and Tolerancing (GD&T), and statistical analysis.
- 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.
- Demonstrates technical coaching and leadership of peers.
- Demonstrated ability to prioritize tasks and lead a varied workload to meet team objectives.
- Demonstrated ability to execute long-term product development deliverables.
- 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.
- Ability to move about inside the office to access file cabinets, office machinery, etc.
- Wear clean room gowns, hair nets, gloves, safety glasses, and shoe covers for extended periods of time.
- Ability to operate lab instrumentation and equipment.
- Lead the development of new designs and/or processes at all stages, from concept creation to launched product.
- 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.
- Develop product specifications, drawings, test protocols and reports.
- Convert user needs to input, develop verification and validation strategies, and conduct risk management activities.
- Develop verification and validation strategies and conduct risk management activities.
- Generate design history files following FDA and international standards.
- Identify product risks and mitigate through design and process improvements.
- Provide technical guidance and coaching of other engineers.
- Provide project and technical communication to cross functional teams for devices through clinical development, product registration and commercialization.
- Contribute to the creation of design control elements to comply with medical device regulations.
- Contribute to internal project planning and execution to meet schedule and budget requirements.
- Work with functional managers and partners to ensure project goals are met.
- Support manufacturing process development.
- Ensuring accurate and controlled documents are generated.
- Contribute to a dynamic start-up environment.
- Produces design models, drawing details, assembly drawings, and associated engineering documentation with 3-D parametric modeling software.
- Directly communicate with partners translating their needs to product design.
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Enable Injections Inc
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