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Title:  Engineer II, 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.

 

PURPOSE OF POSITION:  With direction and coaching, the Engineer II, Product Development will apply experience to support the design and development of novel medical devices from product inception to commercial release in order to meet the company’s strategic goals.

 

QUALIFICATIONS

 

 

 

Required:

 

  • Bachelor's degree or higher in Mechanical Engineering, Biomedical Engineering, or related field from an accredited university.
  • A minimum of 2 years of product development experience; OR a master’s degree in related field.

 

Preferred:

  • Knowledgeable in product design and development activities in a regulatory environment.
  • Experience with plastic injection-molded part design.
  • Proficiency in SolidWorks.
  • Understanding of Geometric Dimensioning and Tolerancing (GD&T).

 

Skills & Competencies:

 

  • Working knowledge 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.

RESPONSIBILITIES:

 

  • Supports 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.
  • Generate design history files following FDA and international standards.
  • Support manufacturing process development.
  • Provides project status to leadership.

 

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.