Senior Engineer/Manager, Combination Product Development

Kiniksa is seeking a highly motivated Senior Engineer/Manager, Combination Product Development to join our Drug Product Development team in Lexington, MA. Reporting to the Senior Director, Drug Product 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 device design control and risk management for combination products with input from cross-functional teams

• Draft, review, and approve design control documents. Plan and support execution of design verification and design validation studies

• Identify and maintain user needs

• Develop, manage, execute, and support human factors studies. Conduct user related risk assessments and perform ethnographic analysis

• Establish risk management strategies and associated documentation (Hazard Analysis, Fault Tree, FMEAs)

• 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 and development. Identify ways to improve platform efficiency

• Manage external vendors and partners to advance project milestones

• Summarize and communicate project updates to stakeholders

Qualifications:

• Requires a Bachelor's degree in mechanical or biomedical engineering related field of study with 6+ years relevant industry experience; or a 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 Analysis

• Previous experience with combination products is preferred, such as autoinjectors, co-packed kits, pre-filled syringes

• Ability to manage multiple priorities and work with ambiguity

• Preference will be given to candidates with hands-on experience with injection devices and inhalers

• Strong commitment to compliance and ethical standards

• Proficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.)

• Ability to travel up to 5%

• Salary is commensurate with experience

• Kiniksa Benefits Summary - USA

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.