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Title:  Senior Engineer, R&D

Requisition Number: 
Description: 

 

Enable Injections is made up of a team passionate about working together to make people’s lives better. We develop, manufacture, and support the enFuse®, a platform of wearable infusion devices designed to enable subcutaneous self-administration of high-volume therapeutics. Enable employees are technology experts focused on an exceptional patient experience in collaboration with our biopharma partners.

 

 

The Senior Engineer will be performing research, development and feasibility activities for both new and sustaining programs as related to patient self-administrated drug delivery systems. Responsibilities include developing creative solutions to design problems, ensuring the proper engineering deliverables are completed, generation of 3D CAD models, 2D CAD drawings, test procedures and reports, tooling/jigs and other components, and generation and execution of project schedules. This individual will work closely with other engineers, designers, manufacturing, marketing, quality and regulatory staff to assure specifications are met with technically strong, high quality, cost effective designs following a defined development process.

 

Major Responsibilities:

 

  1. Technical guidance and oversight of younger engineers in the development of new designs, test methods and/or processes.
  2. Contributing to development of new designs and/or processes at all stages, from concept creation to launched product using good manufacturing practices.
  3. Coordinates, manages, and documents project progress.
  4. Broad use and application of mechanical engineering principles, concepts, theories and techniques to solve problems related to product development, manufacturing, and design.
  5. Produces design models, detail drawings, assembly drawings, and associated engineering documentation with 3-D parametric modeling software, MS Word, MS Excel and MS Power Point.
  6. Designing and conducting experiments to verify product performance.
  7. Designs and coordinates complex engineering tests and experiments by producing engineering documentation that includes protocols and reports.
  8. Translates customer needs into product requirements and design specifications.
  9. Demonstrates a commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

 

 

Educational Requirements:               Bachelor’s Degree in Mechanical Engineering, Biomedical Engineering, or equivalent combination of education, training, and experience.

 

Experience Requirements:                A minimum of 10 years of development experience, preferable with fluid / drug delivery devices.  Other work experience can substitute for minimum requirements at management discretion.

 

Knowledge and Skills                           Knowledgeable in product design and development activities in a regulated environment.  Familiar with medical device manufacturing assembly and test methods. Possess a good balance of technical expertise and analytical thinking with evidence of mentoring younger engineers and staff members.  Competent with Solid Modeling (preferable SolidWorks), spreadsheet and statistical analysis software (e.g. Minitab) packages. Hands-on experience with medical devices that require mold making, machining, fabrication and assembly. Familiar with in-vivo testing preferred.

 

 

We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, national origin, disability status, protected veteran status or any other characteristic protected by law.  


Nearest Major Market: Cincinnati