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Title:  Senior Manager, Human Factors

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 Sr. Manager, Human Factors Engineering is responsible for directing personnel and operations involved in human factors engineering to support the product lifecycle for all drug delivery platforms and drug partner relationships.  Responsibilities include execution of a Human Factors program (SOPs, protocols, reports, task analysis etc.), ensuring compliance with regulatory requirements, overseeing and mentoring staff execution of human factors activities over the product lifecycle and associated risk management activities as well as budget management. 

 

QUALIFICATIONS

 

 

Required:

  • BS, MS or PhD in Human Factors / Usability Engineering, Biomedical Engineering or related field.
  • A minimum of 10 years of experience in combination product and/or device development engineering in a pharmaceutical, medical device, regulated environment or master’s degree plus 8 years’ experience in related field.

Preferred:

  • Direct or matrixed experience managing people and projects 
  • Experience working in matrix managed teams and participating on more than one project at a time.

Skills & Competencies:

  • Experience applying Human Factors / Usability Engineering, including design and execution of formative and summative studies, to the design and development of drug delivery systems is preferred. Experience with medical devices required. 
  • Working knowledge and experience with applicable HF regulations and with ISO, FDA, International regulations, and ASTM standards is required.
  • Experience representing HF body of work to during regulatory interactions and other types of audits. 
  • Accomplished at project planning, organizing and communication. Independent and responsive to input, diplomacy and persuasion, ability to find common ground and resolution. Can interface effectively with research, product development, operations, and external suppliers and manufacturers as well as senior management. 
  • Proficiency utilizing the MS Office Suite (Word, Excel, PowerPoint etc.) is required.  

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:

  • Provide HF input to strategic company objectives and plan execution (projects and staff) against those objectives.
  • Recruit, manage, and mentor staff to execute department functions; ensure effective utilization of resources through consistent performance management and recognized practices in area of responsibility.
  • Provides leadership, guidance and direction to staff in alignment with cGMP requirements, department goals and corporate quality standards. 
  • Proactively identify, assess and mitigate operational and organizational risks; escalate key risks and issues to senior management and cross-functional support teams.
  • Develop department budget and track spend.
  • Ensure staff has appropriate knowledge of department processes and procedures to perform job responsibilities.
  • Provide leadership in Human Factors / Usability Engineering in the design, development, testing, commercialization and life cycle management of drug delivery systems working closely with other department such as Regulatory, Quality, Manufacturing, Clinical and Commercial.
  • Identify and keep current a list of external human factors experts for consultation as needed.
  • Mentor, educate and direct personnel on Human Factors-related activities and processes.

 

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