Staff Design Quality Engineer

About Us

iota Biosciences, a wholly owned subsidiary of Astellas Pharma US, is advancing a new class of bioelectronic medicines through the development of fully implantable Class III medical devices. Our proprietary technologies open therapeutic and diagnostic possibilities not previously accessible to clinicians.

Together with Astellas, we are committed to patient-centric design, scientific and engineering excellence, and cross-functional teamwork. These principles guide us in bringing transformative, first-of-its-kind technologies into the clinic and closer to patients.

The Role

We are seeking a Staff Design Quality Engineer (DQE) for our urological therapy program. This role serves as a critical technical leader responsible for ensuring that product development activities for Class III active implantable devices comply with global regulatory and quality standards/requirements. The DQE is the subject matter expert in design controls, risk management, and product lifecycle quality, collaborating cross-functionally with Engineering, Manufacturing, Regulatory and Clinical teams to deliver safe and effective products to market. This role is ideal for someone who thrives in a dynamic, fast-paced environment and can balance flexibility with structure, guiding teams through complex regulatory requirements while implementing pragmatic, stage-appropriate processes.

What You’ll Do

• 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

What We’re Looking For

• 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.

• Familiarity with Design for Manufacturability

• Experience with implementation of Statistical Process Controls (SPC)