Product design [h1.location_city]
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Product design • chicago il
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Be among the first 25 applicants.This range is provided by The Steely Group.Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.Senior Manager, Devi...[show_more][last_updated.last_updated_variable_days]
A leading global software company is seeking a Senior Product Designer to innovate and reshape its design system for new AI-powered products.
The role involves driving initiatives for the Design Sys...[show_more][last_updated.last_updated_1_day]
A technology company is seeking a Product UI Designer to evaluate AI-generated designs and provide feedback to improve AI understanding of visual principles.
In this remote role, you will assess AI ...[show_more][last_updated.last_updated_variable_days]
Serena & Lily, lifestyle and home furnishings brand, is seeking Associates / Design Advisors our store in Chicago, IL.Design Shop Advisors are responsible for creating a best-in-class client experien...[show_more][last_updated.last_updated_variable_days]
Orion Engineers, PLLC was founded to make a difference to our employees, clients, and fellow military veterans who bravely served our country.
Our team of dynamic and diverse professionals drive cre...[show_more][last_updated.last_updated_30]
Our product suite can adapt to the needs of diverse industries and use cases within one powerful platform, empowering ~245,000 customers worldwide to reimagine how work gets done, drive greater eff...[show_more][last_updated.last_updated_variable_days]
Are you a persuasive visual storyteller? A driven master at social-first content creation? A strategic and creative problem-solver who relishes the challenge scaling creative scale while still keep...[show_more][last_updated.last_updated_30]
A company is looking for a Director, Product Design to lead its global design organization.Key Responsibilities Define and execute a unified design strategy to enhance AI-powered user experiences...[show_more][last_updated.last_updated_30]
Let’s be unstoppable together!.At Circana, we are fueled by our passion for continuous learning and growth, we seek and share feedback freely, and we celebrate victories both big and small in an en...[show_more][last_updated.last_updated_30]
Discovery, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community.
Please do not contact the recruiter directly.Discovery… the stuff dreams are...[show_more][last_updated.last_updated_variable_days]
Product Design Definition Support Location : Remote.Pay Range : $38-48 6 month contract.Deadline to apply is 12 / 22 / 2025.
Citizenship Requirement : US Person.Security Clearance Level : None.Min years of ...[show_more][last_updated.last_updated_variable_days]
This role requires a balance of creative vision, technical knowledge, and project management expertise.We are looking for an individual with a passion for high-end residential design, strong techni...[show_more][last_updated.last_updated_30]
You’re not the person who will settle for just any role.Because we’re out to create Better Care for a Better World, and that takes a certain kind of person and teams who care about making a differe...[show_more][last_updated.last_updated_variable_days]
Candidates who live near CB offices have the option of being fully remote or hybrid (Tuesday and Wednesday in office).The Scoring & Reporting domain delivers the core scoring and score-reporting se...[show_more][last_updated.last_updated_variable_days]
Expedia Group brands power global travel for everyone, everywhere.We design cutting-edge tech to make travel smoother and more memorable, and we create groundbreaking solutions for our partners.Our...[show_more][last_updated.last_updated_30]
Mercor is seeking Product Design / UX Experts as independent contractors working on a research project • •for one of the world’s top AI companies.
This project involves using your professional experien...[show_more][last_updated.last_updated_variable_days]
CB2 is transforming the perception of home design for today's modern consumer.Born out of Crate and Barrel, CB2 is committed to high-quality, sophisticated design at an approachable price.Located i...[show_more][last_updated.last_updated_variable_days]
A telecommunications company is seeking a remote Product Designer to create and refine user experiences across a range of platforms, including GUIs, APIs, and documentation.This full-time, entry-le...[show_more][last_updated.last_updated_variable_days]
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Sr. Manager, Combination Product Design
The Steely GroupChicago, IL, United States[job_card.variable_days_ago]
[job_preview.job_type]
- [job_card.full_time]
[job_card.job_description]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 the Chicago office and requires a minimum of four days per week on-site. On-site requirements may change at management’s discretion. Mid-Senior level Full-time Research, Engineering, and Science Pharmaceutical Manufacturing and Biotechnology Research Medical insurance Vision insurance 401(k)
2 days ago Be among the first 25 applicants
This range is provided by The Steely Group. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range
$175,000.00 / yr - $250,000.00 / yr
The Senior Manager, Device Development is accountable for the technical development of device and combination product programs to ensure commercialization strategy and objectives are met. This role identifies and leads development projects for device and combination product delivery systems, according to established standards for Design Controls and product development processes. This includes providing leadership to a cross-functional team, encompassing all aspects of device development : design input, design output, specification development, test method development, design verification / validation, process validation, design transfer, and risk management.
The Senior Manager leads the coordination and collaboration with contract development and manufacturing organizations (CDMOs), by serving as the key liaison between internal departments and these key external stakeholders. This role is also responsible for compiling and maintaining the Device History File (DHF) and Device Master Record (DMR) and makes significant contributions to associated regulatory submissions.
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.
Qualifications
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