Senior Manager, Device Development and Manufacturing

Kiniksa is seeking a highly motivated Senior 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):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 milestonesDevelop, manage, execute, and support human factors studies. Conduct use-related risk assessmentsExecute design verification and validationConduct impact assessments for Change Control, including DHF/RMF assessmentsAuthor and review of regulatory submissions and responsesAssist in platform device selection and packaging design for new programs by performing feasibility testsSummarize and communicate project updates to stakeholdersQualifications and Experience:Requires a Bachelor's degree in mechanical or biomedical engineering related field of study with 8+ years of relevant industry experience; or Master's degree (preferred) with 6+ years of relevant industry experienceKnowledge 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 ManagementPrevious experience with combination products is required, such as autoinjectors, co-packed kits, pre-filled syringes, inhalersAbility to manage multiple priorities and work with ambiguityStrong commitment to compliance and ethical standardsAbility to travel up to 5%Salary is commensurate with experienceKiniksa Benefits Summary - USAThe pay range for this position is $164,000 - $175,000. Compensation is subject to change commensurate with industry standards and the candidate's relevant experience and qualifications.Kiniksa is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, transgender status, age, genetics, national origin, protected veteran status, or disability status, or any other legally protected category. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.