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Title:  Manager, 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:

The Manager, Product Development is responsible for leading a team of engineers in the development of new devices to meet business requirements.

 

QUALIFICATIONS

 

Required:

 

 

  • Bachelor's degree or higher in Mechanical or Biomedical Engineering from an accredited university.
  • A minimum of 15 years of medical device product development experience following FDA design controls.
  • A minimum of 5 years’ experience in development and management of engineering teams.

Preferred:

  • Expertise with plastic injection-molded part design for large scale automation.
  • Proficiency in SolidWorks.

 

Skills & Competencies:

 

  • Strong analytical skills and creative problem-solving skills.
  • Leadership skills necessary to manage and develop a team
  • Proficiency in mechanical design fundamentals, solid modeling, tolerance stack analysis, design for manufacturing, Geometric Dimensioning and Tolerancing (GD&T), and statistical analysis.
  • Ability to effectively plan and manage priorities.
  • Ability to delegate, hold others accountable, and communicate expectations.
  • Excellent technical writing and presentation skills.
  • Interpersonal skills required to work effectively with cross-functional groups in releasing new products on time and on budget.

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. 

 

RESPONSIBILITIES:

  • Act as technical lead on projects in the design and development of medical device products and components that adhere to company procedures, industry regulations and customer standards.
  • Collaborate with functional managers and partners to ensure project goals are met.
  • Generate design inputs from user needs to establish product specifications.
  • Apply mechanical engineering principles and techniques to solve challenges related to product design, manufacturing, assembly, and testing.
  • Generate design history files following FDA and international standards.
  • Define product risks and mitigate through design and process improvements.
  • Prepare and oversee budgets for projects.
  • Provide technical guidance and coaching to engineering staff on a regular basis and document annual performance reviews.
  • Determine staffing and training needs for department and monitor allocation of resources.
  • Contribute to a dynamic start-up environment.

 

 

 

 

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