Software Design Control Engineer
Echo NeurotechnologiesSan Francisco, California, United States · Posted 1 month agoDescription
Company Overview
Echo Neurotechnologies is an exciting new startup in the Brain-Computer Interface (BCI) space, driving innovation through advanced hardware engineering and AI solutions. Our mission is to deliver cutting-edge technologies that restore autonomy to people living with disabilities and improve their quality of life.
Team Culture
Join a small, dedicated team of knowledgeable and motivated professionals. Our early-stage environment offers the opportunity to take ownership of broad decisions with significant and long-lasting impact. We emphasize continuous learning and growth, fostering cross-functional collaboration where your contributions are vital to our success.
Job Description
We are seeking a Software Design Control Engineer to drive end-to-end documentation and process rigor across our Class III medical device software products, supporting both clinical trials and commercialization. This role sits at the intersection of software engineering, quality systems, and regulatory compliance. You will bring medical device best practices across quality and engineering to ensure our software is safe, effective, compliant, and ready for market.
Role Responsibilities
- Embedded Design Controls: Work alongside software engineers to author, review, and maintain comprehensive design control documentation, including Software Requirements Specifications, Architecture & Design Documents, and Traceability Matrices.
- Lifecycle Compliance: Ensure software development processes align with IEC 62304 (Medical Device Software Lifecycle), ISO 13485, and FDA 21 CFR Part 820 regulations.
- Risk Management: Author and maintain software risk management files, including Software FMEAs per ISO 14971.
- V&V Partnership: Produce software verification and validation (V&V) protocols and reports in coordination with the engineering and test teams to ensure full traceability.
- Regulatory Submission Prep: Compile and organize necessary software technical documentation for regulatory submissions.
- Post-Market Support: Maintain and update software documentation for post-market surveillance, CAPAs, and software updates.
Qualifications
Required Qualifications
- Experience: 5+ years of experience in the medical device industry, specifically working with software-driven or connected medical devices (Class II or Class III).
- Technical Background: A Bachelor’s degree in Computer Science, Biomedical Engineering, Software Engineering, or a related field, or equivalent practical engineering experience.
- Technical Writing: Demonstrated experience writing, reviewing, and managing formal medical device software documentation (Design History Files, Traceability Matrices).
- Product Lifecycle: Proven track record of taking a medical device software product through a successful FDA clearance/approval process and subsequent launch.
Preferred Qualifications
- Standards Expertise: Deep familiarity with IEC 62304, ISO 14971, and FDA Software Validation Guidelines.
- Tooling: Experience with modern software development workflows (e.g. Git, Jira) and quality system tools (e.g. Greenlight Guru, Arena, Matrix Requirements, or Jama).
- Post-Market Management: Experience maintaining medical device software post-launch, including managing software changes and compliance updates.
What We Offer
-
An opportunity to work on exciting, cutting-edge projects to transform patients’ lives in a highly collaborative work environment.
-
Competitive compensation, including stock options.
-
Comprehensive benefits package.
-
401(k) program with matching contributions.
Equal Opportunity Employer
Echo Neurotechnologies is an Equal Opportunity Employer (EOE). We celebrate diversity and are committed to creating an inclusive environment for all employees.
Confidentiality
All applications will be treated confidentially. Applicants may be asked to sign an NDA after the initial stages of the interview process.
Similar jobs
Est. 170,000 USD
Company Overview Echo Neurotechnologies is an exciting new startup in the Brain-Computer Interface (BCI) space, driving innovation through advanced hardware engineering and AI solutions. Our mission is to deliver cutting…
Est. 165,000 USD
Company Overview Echo Neurotechnologies is an exciting new startup in the Brain-Computer Interface (BCI) space, driving innovation through advanced hardware engineering and AI solutions. Our mission is to deliver cutting…
Est. 225,000 USD
Company Overview Echo Neurotechnologies is an exciting new startup in the Brain-Computer Interface (BCI) space, driving innovation through advanced hardware engineering and AI solutions. Our mission is to deliver cutting…
Est. 195,000 USD
Company Overview Echo Neurotechnologies is an exciting new startup in the Brain-Computer Interface (BCI) space, driving innovation through advanced hardware engineering and AI solutions. Our mission is to deliver cutting…
Est. 182,500 USD
Company Overview Echo Neurotechnologies is an exciting new startup in the Brain-Computer Interface (BCI) space, driving innovation through advanced hardware engineering and AI solutions. Our mission is to deliver cutting…
Est. 200,000 USD
Company Overview Echo Neurotechnologies is an exciting new startup in the Brain-Computer Interface (BCI) space, driving innovation through advanced hardware engineering and AI solutions. Our mission is to deliver cutting…
Est. 107,500 USD
Company Overview Echo Neurotechnologies is an exciting new startup in the Brain-Computer Interface (BCI) space, driving innovation through advanced hardware engineering and AI solutions. Our mission is to deliver cutting…
Est. 180,000 USD
Company Overview Echo Neurotechnologies is an exciting new startup in the Brain-Computer Interface (BCI) space, driving innovation through advanced hardware engineering and AI solutions. Our mission is to deliver cutting…
Est. 165,000 USD
Company Overview Echo Neurotechnologies is an exciting new startup in the Brain-Computer Interface (BCI) space, driving innovation through advanced hardware engineering and AI solutions. Our mission is to deliver cutting…
Est. 135,000 USD
Company Overview Echo Neurotechnologies is an exciting new startup in the Brain-Computer Interface (BCI) space, driving innovation through advanced hardware engineering and AI solutions. Our mission is to deliver cutting…
Est. 290,000 USD
Company Overview Echo Neurotechnologies is an exciting new startup in the Brain-Computer Interface (BCI) space, driving innovation through advanced hardware engineering and AI solutions. Our mission is to deliver cutting…
Est. 147,000 USD
About Neuralink: We are creating devices that enable a bi-directional interface with the brain. These devices allow us to restore movement to the paralyzed, restore sight to the blind, and revolutionize how humans intera…
Est. 145,000 USD
Company Overview Echo Neurotechnologies is an exciting new startup in the Brain-Computer Interface (BCI) space, driving innovation through advanced hardware engineering and AI solutions. Our mission is to deliver cutting…
Est. 195,000 USD
Company Overview Echo Neurotechnologies is an exciting new startup in the Brain-Computer Interface (BCI) space, driving innovation through advanced hardware engineering and AI solutions. Our mission is to deliver cutting…
Est. 215,000 USD
Company Overview Echo Neurotechnologies is an exciting new startup in the Brain-Computer Interface (BCI) space, driving innovation through advanced hardware engineering and AI solutions. Our mission is to deliver cutting…
Est. 124,000 USD
Company Overview Echo Neurotechnologies is an exciting new startup in the Brain-Computer Interface (BCI) space, driving innovation through advanced hardware engineering and AI solutions. Our mission is to deliver cutting…
Est. 95,000 USD
About Neuralink: We are creating devices that enable a bi-directional interface with the brain. These devices allow us to restore movement to the paralyzed, restore sight to the blind, and revolutionize how humans intera…
Est. 205,000 USD
Company Overview Echo Neurotechnologies is an exciting new startup in the Brain-Computer Interface (BCI) space, driving innovation through advanced hardware engineering and AI solutions. Our mission is to deliver cutting…
Est. 204,500 USD
About Cleerly We’re Cleerly – a healthcare company that’s revolutionizing how heart disease is diagnosed, treated, and tracked. We were founded in 2017 by one of the world’s leading cardiologists and are a growing team o…
Est. 95,000 USD
About Neuralink: We are creating devices that enable a bi-directional interface with the brain. These devices allow us to restore movement to the paralyzed, restore sight to the blind, and revolutionize how humans intera…
Est. 170,000 USD
Heartflow is a medical technology company advancing the diagnosis and management of coronary artery disease, the #1 cause of death worldwide, using cutting-edge technology. The flagship product—an AI-driven, non-invasive…
Est. 124,000 USD
Noctrix Health is redefining the treatment of chronic neurological disorders with clinically validated therapeutic wearables. Our team of medical device specialists, neuroscientists, and consumer electronics engineers is…
Est. 215,000 USD
Heartflow is a medical technology company advancing the diagnosis and management of coronary artery disease, the #1 cause of death worldwide, using cutting-edge technology. The flagship product—an AI-driven, non-invasive…
Est. 144,425 USD
At Tactile Medical, we specialize in developing at-home therapy devices to treat lymphedema, chronic venous insufficiency and respiratory illnesses. Position Summary At Tactile Medical, we specialize in developing at-hom…
Est. 154,000 USD
About Neuralink: We are creating devices that enable a bi-directional interface with the brain. These devices allow us to restore movement to the paralyzed, restore sight to the blind, and revolutionize how humans intera…
Est. 215,500 USD
About Neuralink: We are creating devices that enable a bi-directional interface with the brain. These devices allow us to restore movement to the paralyzed, restore sight to the blind, and revolutionize how humans intera…
Est. 177,500 USD
ABOUT INSPIRE MEDICAL SYSTEMS Inspire is the first of its kind medical device designed to make a difference in the lives of those living with Obstructive Sleep Apnea (OSA). We are revolutionizing the sleep industry with…
Est. 205,000 USD
Company Overview Echo Neurotechnologies is an exciting new startup in the Brain-Computer Interface (BCI) space, driving innovation through advanced hardware engineering and AI solutions. Our mission is to deliver cutting…
Est. 249,500 USD
About Ceribell Ceribell is a medical technology company focused on transforming the diagnosis and management of patients with serious neurological conditions. The Ceribell System is a novel, point-of-care electroencephal…
Est. 112,320 USD
At Tactile Medical, we specialize in developing at-home therapy devices to treat lymphedema, chronic venous insufficiency and respiratory illnesses. Position Summary At Tactile Medical, we are committed to helping patien…