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Title:  Senior Engineer, Product Development

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.

 

SUPERVISOR’S TITLE:  Director, Product

Development

 

 

PURPOSE OF POSITION:  With minimal support and coaching, the Senior Engineer, Product Development will develop new medical devices to meet business needs and provide leadership on development projects from inception to commercial release.

 

QUALIFICATIONS

 

 

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

Preferred:

  • 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

Skills & Competencies:

  • 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

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.
  • 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

 

RESPONSIBILITIES:

  • Substantial contributions to 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.

           

 

 

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