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Head of Engineering

iota Biosciences, Inc. -
Alameda, CA

Apply Now

Job Details

Full-time
$230,000 - $311,000 a year

Qualifications

Developing medical devices
Managing medical device teams
Strategic goal setting
New product introduction engineering projects
Product development project management
Leadership development
Team development
Managing engineering teams
Mentoring
Leading team collaboration initiatives
Regulatory/legal compliance standards in production
Biomedical regulatory compliance
Product strategy
Business requirements
Risk & issue management
Leadership development initiative
Project stakeholder communication
Stakeholder relationship building
Cross-functional communication
Stakeholder management

Full Job Description

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 active 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.

Role Overview

The Head of Engineering reports directly to the CEO and serves as the company's senior engineering leader and strategic advisor.

This role is responsible for ensuring that engineering, manufacturing, and product development efforts are aligned with the company's clinical, regulatory, and commercialization objectives. The Head of Engineering will partner closely with the CEO and executive team to guide major company decisions, assess risks and dependencies, and help the organization navigate the transition from clinical-stage development through PMA and early commercialization.

The successful candidate will inherit a strong engineering leadership team and will be expected to elevate organizational effectiveness, strengthen cross-functional execution, and provide experienced leadership through a critical stage of growth. Success in this role will come not from direct ownership of technical architecture, but from enabling strong decision-making across the organization, connecting work across engineering functions, and helping leaders anticipate challenges before they become obstacles.

This individual should bring firsthand experience developing and bringing medical devices through PMA pathways, allowing them to provide perspective, identify risks and opportunities, and help the company make informed strategic and long-term investments.

What You'll Do

Executive Leadership and Strategic Partnership

Serve as a trusted advisor to the CEO and Executive Team, helping translate complex engineering and product development topics into actionable business decisions.
Provide independent judgment on major company decisions, investments, risks, resource allocation, and strategic priorities.
Represent engineering perspectives in executive, investor, partner, and board-level discussions as appropriate.
Help the organization make sound tradeoffs between technical risk, regulatory requirements, timelines, cost, manufacturing readiness, and long-term platform strategy.
Partner with executive leadership to shape product portfolio strategy and roadmap planning, ensuring alignment between near-term milestones and long-term company objectives.

Engineering Leadership

Lead and further develop iota's engineering leadership team across electrical, firmware, software, systems, mechanical, and manufacturing engineering.
Provide coaching, mentorship, and leadership support to an already strong group of engineering leaders, helping elevate organizational effectiveness and execution.
Ensure alignment across engineering functions by identifying dependencies, surfacing risks early, and facilitating effective decision-making.
Establish clear expectations, accountability, communication, and decision-making frameworks across the engineering organization.
Partner with engineering leaders to ensure teams remain focused on company priorities while preserving clear ownership of architecture and day-to-day technical decisions within each function.
Build strong, trusted relationships with engineering leaders and key cross-functional stakeholders.

Product Development, Regulatory, and Commercialization Execution

Guide engineering activities supporting pivotal clinical studies, PMA submission, approval, and commercialization readiness.
Leverage prior PMA experience to help the organization anticipate challenges, evaluate tradeoffs, and make informed decisions throughout the product lifecycle.
Ensure appropriate engineering rigor, design controls, risk management, verification, validation, and development processes are in place.
Partner closely with Quality, Regulatory, Clinical, Operations, Manufacturing, and Program/Product Management leaders to drive successful execution.
Support commercialization planning and manufacturing scale-up activities while maintaining product quality and regulatory compliance.

Organizational Development

Mentor and develop engineering leaders and high-potential talent.
Build organizational capabilities that scale with company growth.
Create succession plans and leadership development pathways within the engineering organization.
Foster a culture of accountability, collaboration, transparency, and continuous improvement.

Required Qualifications

BS in Engineering or related technical field.
Willingness to work from our Alameda office approximately three days per week.
Significant experience developing and bringing active Class III medical devices through PMA pathways, with the ability to apply those lessons to strategic planning, risk management, and organizational decision-making.
Proven success leading multidisciplinary engineering organizations in regulated medical device environments.
Demonstrated ability to develop strong engineering leaders
Strong communication, stakeholder management, and organizational leadership skills.
Demonstrated ability to build trust and influence across technical and non-technical teams.
Experience balancing innovation with regulatory, quality, clinical, and business requirements.
Ability to understand and connect work across multiple engineering disciplines, identify dependencies and risks, and drive alignment across teams.

Preferred Qualifications

Global regulatory experience, including CE Mark and MDR.
Experience operating in fast-paced, resource-constrained environments where leaders are expected to navigate ambiguity, solve novel problems, and take ownership beyond traditional functional boundaries.

Why Join Us

This is a rare opportunity to help shape the future of bioelectronic medicine at a pivotal moment in the company's journey.

You will partner directly with the CEO and executive team, guide critical organizational and strategic decisions, help prepare the company for its next phase of growth, and contribute to the development of therapies that have the potential to transform patients' lives.

At iota, you'll join a mission-driven team tackling some of the most challenging problems in medicine through a unique combination of scientific innovation, engineering excellence, and patient-centered design.

Compensation Range: $230K - $311K

Apply Now

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architectural and engineering managers jobs in concord, ca

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