
13 Nov Biomedical Systems Engineer
Company Profile:
NeuroCatch Inc. is a neuro-health technology company focused on translating neuroscience research innovations into real-world medical devices and consumer products.
Located within the Health and Technology District in Surrey, British Columbia, NeuroCatch Inc. is a wholly owned subsidiary of HealthTech Connex (www.healthtechconnex.com). It’s first medical device, the NeuroCatch™ Platform is a rapid neuro-physiological brain function assessment system that is easy-to-use, cost-effective and readily accessible.
The company’s mission is to revolutionize the way the brain is measured by transforming ground-breaking research & development into commercial devices that can positively impact brain health around the world. www.NeuroCatch.com
Position Summary:
As the Biomedical Systems Engineer you will help bring new medical devices to commercialization while supporting existing medical devices in the market. You will be an integral part of a multidisciplinary team, and will have the opportunity to work across key functions such as manufacturing, testing, design, and quality.
Duties and responsibilities:
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- Writing Verification & Validation plans, test protocols, and reports
- Designing and validating electronic test jigs for simulating and testing brain wave signals
- Identifying system requirements and design inputs for medical device projects
- Prototyping hardware and electronics, sourcing components
- Writing software test pipelines for signal analysis and interfacing with test jigs
- Assisting with Hazard Analyses and Risk Analyses on proposed design iterations
- Ensuring device compliance with Canadian and international medical device regulatory standards
- Supporting regulatory filings to various organizations
- Leading the transfer-to-production process in compliance with the applicable standards
- Leading Validation/Verification of production test jigs
- Optimizing and overseeing the production process
- Performing root cause analysis with failed components and systems with external vendors
- Supervising a manufacturing technician and ensuring all quality system documentation requirements are met
- Maintaining Device Master Record and Design History File documents according to Standard Operating Procedures
- Ensuring compliance with Design Control requirements for all employees’ work in the project
- Participating in Design Review meetings and Design Transfers to implement new designs
- Working with Quality Assurance to close CAPAs, Investigations, and Change Controls
- Working with Product Manager to improve device usability through improved user instructions and/or through usability testing
- Working with Product Manager to resolve complaints and improve product based on feedback
- Working with Project Manager to resolve device deficiencies through improved design and processes
- Working with Project Manager to develop and outline project timelines, milestones, and deliverables
- Contributing to design of effective and usable cleaning and disinfection procedures according to International Standards
- Transferring R&D knowledge into repeatable and manufacturable designs and processes for compliant medical devices
- Assisting with R&D tasks, creative problem solving, and presenting long-term project goals
- Maintaining up-to-date knowledge and awareness of the state of the medical device industry
- Reading and understanding the latest neurological literature
- Integrating modern neuroscience concepts into useful medical equipment
- Designing system architecture to adapt state-of-the-art EEG hardware with proprietary software
- Working with Sr. Software Engineer to optimize EEG/ERP signal processing algorithms
- Writing proof-of-concept software scripts for demonstrating feasibility of design architectures
Desired Experience & Qualifications:
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- Bachelors or master’s degree in biomedical engineering or equivalent designation
- 2+ years experience in medical device engineering
- Strong understanding of biosignal acquisition, particularly EEG
- Strong understanding of Event Related Potentials an asset
- Strong interpersonal skills and experience in a collaborative team environment
- Excellent written communication and documentation ability
- High level of attention to detail and organization
- Creative problem solving in the domain of physical and abstract systems
- Ability to follow procedures and recognize areas for improvement
- Highly motivated and can achieve goals with minimal supervision
- Can solve technical problems under limited resources
- Familiarity with ISO 13485, ISO 60601, other medical device standards an asset
- Understanding of medical device lifecycle concepts an asset
- Electronic Circuit Design
- Soldering, breadboarding, circuit simulation, or equivalent
- Technical Writing, Technical Communication
- CAD, Solidworks, SVG preparation, 3D Printing, or similar
- Coding in C, Java, Python, MATLAB, or equivalent
- Basic statistics, distributions, error calculations
- Good presentation skills
- IEC 60601-1 Test Strategies
- Commitment to Quality
NeuroCatch Inc. is a great place to work! We provide:
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- Competitive salaries
- Profit sharing
- Extended health and dental benefits
- Flexible vacation and paid time off
- Use of the on-site gym
- Coffee and snacks
- Regular wellness activities
- Fun team events and celebrations
- Enthusiastic and talented co-workers
If you feel that you are innovative, enthusiastic and knowledgeable, submit your resume and explain why you would be a great fit within our company.
If you are among the most suitable for the position, we will be in contact with you directly shortly after the job posting close date. Only those applicants selected for the interview process will be contacted.
NeuroCatch Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
Posting Close Date: October 31, 2019
Job Type: Full-time
Experience:
Biomedical Engineering: 2 years (Preferred)
Education: Bachelor’s Degree (Preferred)
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