iota Biosciences, Inc. powered by Astellas · 2 months ago
Staff Design Quality Engineer - Urological Therapies
Alameda, CA
Full-time
Onsite
Lead/Staff
$134K/yr - $164K/yr
8+ years expiota Biosciences, a subsidiary of Astellas Pharma US, is focused on developing bioelectronic medicines through innovative medical devices. The Staff Design Quality Engineer will lead design quality activities for Class III active implantable devices, ensuring compliance with regulatory standards and collaborating with cross-functional teams to deliver safe products to market.
BiotechnologyLife ScienceMedical
Responsibilities
Lead and oversee design quality activities for new product development and sustaining engineering projects
Drive the implementation and maintenance of design control processes, including design planning, design reviews, verification & validation, and design transfer
Lead risk management activities in accordance with ISO 14971, including hazard analysis, FMEA (DFMEA/PFMEA) and risk-benefit assessments
Provide quality leadership in the development and review of Design History File, Design Master Record, and technical documentation for regulatory submissions (IDE, PMA, etc.)
Partner with Regulatory Affairs to support submissions, audits and inspections
Lead or contribute to root cause investigations and CAPA related to design, development and field performance issues
Serve as the quality representative in cross-functional development teams, ensuring compliance with FDA 21 CFR 820, ISO 13485, ISO 14971, IEC 60601 and ISO 14708 standards
Partner with R&D, Manufacturing Engineering, and Regulatory during design transfer and process scale-up
Support and oversee Process Validations for critical manufacturing processes at a contract manufacturer
Qualification
Required
Bachelor's/Master's degree in Engineering, Biomedical Engineering or related field
8+ years of experience in the medical device design and development with a focus on advancing a novel Class III product from early feasibility through pivotal trials, with at least 5 years in a quality engineering role
Direct experience with Class III active implantable devices or similarly regulated, high-risk medical devices
Strong knowledge of design controls, risk management, and medical device regulations and standards (ISO 13485, FDA 21 CFR Part 820, ISO 14971, etc.)
Demonstrated experience leading design quality efforts from concept through commercialization
Highly effective collaborator across cross-functional teams including engineering, regulatory, clinical, operations, and medical sciences
Hands-on leader skilled at bringing structure and clarity to fast-paced, evolving environments
Strong analytical and problem-solving skills with a proven ability to navigate ambiguity and drive results
Preferred
Familiarity with Design for Manufacturability
Experience with implementation of Statistical Process Controls (SPC)
Company
iota Biosciences, Inc. powered by Astellas
iota Biosciences, a wholly-owned subsidiary of Astellas Pharma US, is a medical device company working to develop pioneering bioelectronics to advance the treatment and management of disease.
51-200 employees
H1B Sponsorship
iota Biosciences, Inc. powered by Astellas 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
2025 (5)
2024 (15)
2023 (6)
2022 (11)
2021 (2)
2020 (1)
Funding
Current Stage
Growth StageTotal Funding
$15M2020-10-15Acquired
2018-12-27Series A· $15M
Leadership Team
Michel Maharbiz
Chief Executive Officer
Recent News
Google Patent
2025-05-05
Google Patent
2025-05-05
2025-05-05
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