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Title:  Senior 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.

 

PURPOSE OF POSITION: The Senior Manager, Product Development is responsible for leading a team of engineers in the successful design, development and transfer to manufacturing of Enable Injections products to meet the needs of our customers.

 

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:

  • Proficiency in SolidWorks
  • Experience leading development projects through to commercialization
  • Experience with cross-functional product development teams
  • Expertise with plastic injection-molded part design for large scale automation
  • Prior experience in auto injector design/development and combination products development

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
  • Knowledge of global industry standards (ex. ISO, AAMI, ANSI, etc.)
  • Proficiency utilizing the MS Office Suite (Project, Word, Excel, PowerPoint, Visio, Outlook)
  • Demonstrated ability to prioritize and organize tasks and lead a varied workload

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:

  • Manage a team responsible for supporting technical leads in design finalization, verification, and commercialization of the EnFuse infusors and ST systems
    • Create development plans and track progress
  • Act as technical Lead for 20 mL infusor and ST system
  • Lead initiatives on characterization of current design for optimization, product improvement related to cost and manufacturability, and evaluation of potential changes during the product lifecycle
  • Balloon science
  • Impact of new suppliers, materials, or processes
  • Alternate sterilization methods
  • Ensure consistent design philosophy and application of technology across all infusor and syringe transfer designs
  • Provide leadership and mentoring to key technical personnel
  • Participate in strategic planning for future product development
  • Support consistent approach to design control methods and deliverables across all infusors
  • Provide input to manufacturing engineering for process development and equipment
  • Track future R&D projects and participate when needed for transfer to PD
  • Liaison between PD and R&D for joint projects and problem solving

 

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