Product Development Engineer

Kytopen is streamlining cell engineering for use in next-generation cell therapies, with the goal of expanding access to powerful new living medicines. We enable transformative therapies with our patent-pending continuous Flowfect® non-viral transfection platform. Flowfect® is a fast, scalable, and gentle process that yields billions of high-quality engineered cells in minutes while maintaining cell health and function. We seek passionate, pioneering individuals to join our mission to deliver this transformative technology.

The Product Development Engineer will have responsibility for the execution of various product development engineering efforts for Kytopen, including the development and iteration of our consumables. The qualified candidate will demonstrate the ability to effectively execute technical development in the areas of mechanical and electrical systems as required for the development of the Kytopen technology components and systems. This individual will work in coordination with internal and external personnel as needed. 

The ideal candidate will possess strong analytical and communication skills and should have at least 5 years of industry experience developing commercial products. 

Responsibilities and Duties (What we need) 

• Identify critical requirements of the customers using our technology, in tandem with Engineering, Commercial, and Biology leadership, and design and build solutions to meet these requirements 

• Capture design intent in manufacturable drawings, with appropriate use of Geometric Dimensioning and Tolerance (GD&T) and Critical to Quality features as needed 

• Identify and interpret the appropriate regulatory standards and guidelines driving design 

• Manage relationships with external partners and suppliers to seamlessly coordinate technology development 

• Use software and hardware techniques and tools to enable efficiencies and technical excellence throughout engineering efforts 

• Understand and utilize Design Excellence / Six Sigma approach in design and development of systems 

• Identify testing needs and approaches, develop test methods, execute necessary testing, with clear documentation of results and impact 

• Write and update protocols, reports, procedures as necessary to support Engineering and Development efforts 

• We are a hybrid workplace and will require you to be onsite in Cambridge at least a few days per week. 

Requirements (About you)

What: 

• At least 5 years of industry experience developing hardware for medical device, diagnostic or pharmaceutical (process equipment or process development) systems, preferably in the cell and gene therapy space 

• Experience developing at least one commercial product from concept to commercial launch 

• Familiarity and experience working in a regulated environment and building products according to Industry Standards, including US FDA GMP/GLP, ISO13485, CE, and other regional regulations and requirements 

• Familiarity and demonstrated excellence designing complex electro-mechanical systems, including concept, prototyping, drafting, assembly, component qualification and testing (including verification and validation) 

• Strong organizational, analytical, problem-solving, root-cause-analysis, and trouble-shooting skills 

• Strong written and verbal communication skills

How:

• Ability to work within a diverse workforce and provide a positive and motivational work environment 

• Scientifically motivated with the ability to design, conduct, and analyze experiments 

• Entrepreneurial and comfortable in a fast-paced environment 

• Ability to adapt to shifting constraints while maintaining high performance and morale 

• Self-motivated and collaborative, with excellent time management 

• Creative and adaptable in identifying and implementing best practices across team 

• Demonstrated leadership ability to exemplify Kytopen’s values of: Impact, Passion, Integrity, Resilience, and Inclusivity 

Benefits:

We are a values-driven, creative team, and we know that we’re only successful because of the talented people on our team. We offer competitive compensation including a 401k match and equity, a comprehensive package of health benefits, and a supportive work environment that includes hybrid work schedules, flexible vacation, paid family leave, and continuing education support.