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Title:  Engineer II, Product Development-Packaging

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:

This person will be responsible for product design activities with principal responsibility to lead our internal efforts around packaging and labelling. This person will support the Program Development Team(s) in designing, developing, validating, and securing all packaging and labelling needs. This role is responsible for meeting the Product Development and Manufacturing needs of our customers through the on-time delivery of high-quality products. This position leads the internal packaging and labelling efforts to assure the successful design, development, and transfer to manufacturing of Enable Injections products. This position assures compliance with the Design Control process and is responsible for all DHF deliverables. This role works hand in hand with the Program Management, Regulatory, Quality, Manufacturing and Marketing to meet program deliverables.

 

QUALIFICATIONS

 

 

Required: 

  • A BS in Biomedical, Mechanical, Packaging Engineering or other relevant technical degree
  • A minimum of 2 years’ experience in the medical device industry or pharma industry
  • Experience in developing and commercializing regulated devices/combination products under Design Control (21 CFR 820) and ISO 14791 requirements
  • Experience with cross-functional product development teams
  • Knowledge of relevant 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
  • Demonstrated problem solving ability
  • Strong communication, influencing, and negotiating skills

 

Preferred:

  • 3+ years’ experience in development and/or manufacturing of medical device or pharma packaging/labeling experience
  • Prior experience in combination products development experience

 

Skills & Competencies:

  • Ability to prioritize tasks and lead a varied workload
  • Able to work independently, provide multiple solutions to problems and effectively execute complex tasks
  • Ability and willingness to learn new skills and work outside normal job responsibilities
  • Excellent verbal and written communication
  • Developing effective technical presentations
  • Contributing to a dynamic start-up environment

 

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:

  • Leading the development of new packaging and labelling designs and/or processes at all stages, from concept creation to launched product.
  • Establish and maintain detailed packaging and labelling project plans, project deliverables, define risks and recommend contingency plans as required.
  • Ensuring accurate and controlled documents are generated meeting DHF requirements.
  • Establish and foster strong collaborative relationships with external design/development, manufacturing partners and service providers.
  • Work with functional managers, program mangers or partners to ensure project goals are met.
  • Promote visibility and transparency of information within packaging and labelling development and other forums to accelerate decision making, obtain alignment, and increase foundational knowledge. 
  • Identify and communicate product and PD related objectives, issues, risks, and where applicable, facilitate cross-PD discussion on impact.
  • Support project strategies that match Enable product and pharma partner goals.
  • Understand and follow the NPD process with a focus on quality.
  • Identify project risks through comprehensive risk management and mitigation assessment working with partners to reduce risk to lowest practical level.
  • Identifies key project constraints such as scope, schedule, budget, resources, and risks and will clearly communicate roles, expectations, and accountabilities to team members on a regular basis.

 

 

 

 

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