Xeris Pharmaceuticals, Inc. · 21 hours ago
Senior Manager, Device Development
Chicago, IL
Full-time
Onsite
Mid, Senior Level
$110K/yr - $220K/yr
6+ years expXeris Pharmaceuticals, Inc. is focused on the technical development of device and combination product programs. The Senior Manager, Device Development will lead development projects, manage cross-functional teams, and ensure compliance with regulatory standards while contributing to the commercialization strategy.
BiotechnologyDiabetesHealth CarePharmaceuticalTherapeutics
Responsibilities
Manage Design and Development activities for new and existing drug/device combination products to ensure they meet or exceed requirements and can be manufactured with the highest quality
Manage device and combination product development projects effectively using available project management tools
Provide subject matter expertise in areas of device development, drug delivery and commercialization
Manage the translation of Target Product Profiles (TPPs) into specifications
Manage design and development in accordance with regulatory regulations
Manage CDMO production for product development, clinical, and commercial launch manufacturing
Work in a cross-functional team environment to troubleshoot and resolve technical and manufacturing-related issues
Work in compliance with established cGMP quality standards
Manage development, manufacturing, and testing operations at contract sites
Adhere to departmental and project budgets
Contribute to authoring device sections for relevant sections of the eCDT for INDs and NDAs
Qualification
Required
An M.S. degree in Biomedical or Mechanical Engineering with a minimum of 6 years of relevant pharmaceutical experience is preferred. A Ph.D. with relevant academic research experience may substitute for some industrial experience. Alternatively, a B.S. in Biomedical or Mechanical Engineering with 8+ years of industry experience will be considered
A minimum of 6 years of experience working with medical devices and pharmaceutical combination products
A minimum of 6 years of experience working in a GMP environment
Demonstrated subject matter expertise in medical devices
Demonstrated experience in the application of device regulations when drafting FDA and EU submissions
Demonstrated experience with engineering documentation and guidelines (i.e. ISO & ASTM)
Experience in the application of device Quality Management Systems (i.e. 21CFR820 & ISO 13485) and cGMP Part 210 & 211 Requirements for finished pharmaceuticals
Demonstrated experience with FDA Design Controls and cGMP principles and related work environments
Experience in CAD Software (SOLIDWORKS preferred)
A minimum of two years of experience with Delivery Device Project Management from Proof-of-Concept stage to Commercialization
Proficient with use of Microsoft Word, PowerPoint, Outlook, and Excel and web-based software for various applications
Knowledge and understanding of IQ/OQ/PQ process, validation of assembly, processing, and analytical test equipment for device and drug product manufacturing
Competencies : Cross functional leadership, Business and strategic alliances and relationships, Results-oriented, Attention to Detail, Interpersonal skills, Verbal and Written Communication skills, Project Management, Analytical skills
Working Conditions : Position may require travel and periodic evening and weekend work, as necessary to fulfill obligations and meet corporate goals. This position is based in Xeris' Chicago office and requires a minimum of four days per week on-site. On-site requirements may change at management's discretion
Benefits
Bonus
Equity
Multiple paid time off benefits
Various health insurance options
Retirement benefits
Company
Xeris Pharmaceuticals, Inc.
We're a growth-oriented biopharmaceutical company improving patient lives by developing and commercializing advanced products across a range of therapies.
201-500 employees
H1B Sponsorship
Xeris Pharmaceuticals, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2021 (1)
Funding
Current Stage
Public CompanyTotal Funding
$548.5MKey Investors
Hayfin Capital ManagementArmistice CapitalDeerfield
2024-03-06Post Ipo Debt· $200M
2022-01-03Post Ipo Equity· $30M
2021-03-11Post Ipo Equity· $27M
Leadership Team
John Shannon
CEO and Director
Kenneth Johnson
Senior Vice President - Clinical Development, Regulatory Affairs, QA and Medical Affairs
Recent News
2026-01-09
The Motley Fool
2026-01-03
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