Documentation Specialist - Development Engineering

​This is a remote opportunity, however location in Richmond, VA or Indianapolis, IN is preferred.  

Kaléo has secured multiple contracts with the U.S. government for the production of new medical countermeasures, with commercialization opportunity to follow. The Documentation Specialist - Development Engineering will have a critical role in the successful execution of these government programs by managing and executing the Design History File (DHF) documentation for new drug/device combination products, creating and maintaining support documentation, including Design History Files, in a state of compliance, and coordinating documentation with internal and external partners.

If you are a detail-oriented engineer with product development experience in the medical device industry, this is an exciting opportunity to work on life-transforming products while operating within a deadline-focused environment with clear objectives and milestones. The collaborative team setting will provide you with learning support while still fostering a high degree of autonomy and responsibility in your area of expertise. Kaléo’s “remote-first” hybrid culture will offer you the flexibility to choose your work location and schedule, placing an emphasis on self-management and adherence to deadlines. At Kaléo, you can feel confident that your work has a tangible impact.  

As Documentation Specialist - Development Engineering you will:

• Manage and execute the Design Controls documentation for new drug/device combination products.  
• Manage the Design History File (DHF) for all development projects, including risk management and design reviews.
• Oversee the review and approval cycles for all DHF documentation so documents are approved according to IMS deadlines and internal SOPs with minimal errors requiring re-approval.
• Support the project managers for Kaléo’s government programs with documentation required by government partners.
• Support regulatory affairs in development and submission of regulatory documentation.
• Create and maintain separate design guides for all Kaléo development projects.
• Work with external consultants on development of drawings, tolerance analyses, test reports/validation and associated design documentation.
• Coordinate the review and approval of documentation with internal and external partners.
• Support the Vice President, Development with key project documentation deliverables.
• Support the project managers of with key documentation deliverables.
• Support internal and regulatory inspections.

A successful Documentation Specialist - Development Engineering will have:

• Adherence to risk-averse and compliant engineering documentation development and management criteria. 
• Strong motivation and self-management skills with the ability to work independently. 
• Analytical approach to understanding and communicating complex mechanical design principles. 
• Excellent communication skills, including detail-oriented technical writing capabilities and the ability to present with confidence to external and internal partners.  
• Desire to serve as a technical resource and subject matter expert to cross-functional teams. 
• Strong drive to achieve results, make recommendations, and pursue continuous improvement. 
• Ability to work collaboratively, with the judgment to know when to escalate for support.  
• Commitment to participating in and upholding an inclusive work environment. 

To be considered for the position, you must have:

• Bachelor’s degree in an engineering discipline. 
• 3+ years of experience in the medical device industry, including experience with product development, test method development and execution. 
• Experience editing design controls and supporting Design History File creation / management for medical devices. 
• Experience supporting risk management and design reviews. 
• Proficiency in SolidWorks and working knowledge of GD&T.
• Working knowledge of 21 CFR 820. 
• Working knowledge of the ISO 11608 series. 
• Ability to travel overnight up to 15%. 

Additional preferred qualifications:

• Mechanical, Biomedical, Chemical engineering degree preferred. 
• Location in Richmond or Indianapolis preferred.  
• Experience creating Predicative Design Controls for Medical Devices preferred.