- Manage combination product design history file (DHF) functioning as SME on design control and risk management.
- Manage external vendors and partners (CMDOs and device testing labs) to advance project milestones
- Develop, manage, execute, and support human factors studies. Conduct use-related risk assessments
- Execute design verification and validation
- Conduct impact assessments for Change Control, including DHF/RMF assessments
- Author and review of regulatory submissions and responses
- Assist in platform device selection and packaging design for new programs by performing feasibility tests
- Summarize and communicate project updates to stakeholders
- Requires a Bachelor's degree in mechanical or biomedical engineering related field of study with 6+ years of relevant industry experience; or Master's degree (preferred) with 4+ years of relevant industry experience
- Knowledge of applicable regulations/standards, such as 21 CFR Part 820/QMSR, ISO 13485, ISO 14971, IEC 62366, Part 4, etc. with a focus on Design Controls and Risk Management
- Previous experience with combination products is required, such as autoinjectors, co-packed kits, pre-filled syringes, inhalers
- Ability to manage multiple priorities and work with ambiguity
- Strong commitment to compliance and ethical standards
- Ability to travel up to 5%
- Salary is commensurate with experience
- Kiniksa Benefits Summary - USA
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Manager, Device Development and Manufacturing - Lexington - Kiniksa Pharmaceuticals
Description
Kiniksa is seeking a highly motivated Manager, Device Development and Manufacturing to join our Drug Product Development team in Lexington, MA. Reporting to the Director, Device Development and Manufacturing, this individual will play a key role in developing Kiniksa's drug-device combination products.
This role is based in our Lexington, MA office. Our office-based employees follow a hybrid schedule of 4 days in the office, and 1 day remote.
Responsibilities (including, but not limited to):
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