Our growth has led to an exciting new opening for an experienced R&D Engineer and an opportunity to work with a dynamic group of motivated engineers.
The R&D Engineer will be responsible for the conceptual development, detailed design, prototype fabrication, and verification of novel medical devices, fixturing, and tooling. This is a challenging role requiring strong familiarity with transcatheter approaches and a proven knowledge of the cardiovascular space.
Under the direct supervision of the engineering team lead and continuous clinical guidance from our specialized physicians, the R&D Engineer’s responsibilities will include, but are not limited to, the following:
- Establishing design specifications to meet device requirements.
- Hands-on prototype development with rapid iteration on designs using in-house tooling.
- Initiating and developing relationships with 3rd party vendors, contractors and manufacturers.
- Verification of designs through ex vivo and in vivo testing.
- Engineering documentation creation.
- Leading multiple projects.
The ideal candidate should have:
- Bachelors Degree in Mechanical/Biomedical Engineering.
- A minimum of 5 years in the medical device industry or equivalent.
- Experience in structural-heart related medical devices is considered a very strong asset.
- A Start-up experience (working in a fast-paced environment) is a plus.
- Good working knowledge of medical device quality & regulatory systems and medical device directives.
- Familiarity with design and testing requirements of medical devices (ISO 13485, ISO 5840, ISO 5910).
- Machine shop experience: milling machines, lathes, drills, grinders, etc.
- Demonstrated ability to work in a small team and conduct exploration of subject areas for novel concepts and approaches.
- Exceptional communication skills and ability to translate clinical requirements into engineering solutions.
- Excellent technical writing skills, and strong ability to understand and analyze technical documents.
- Excellent problem-solving skills, with a high level of attention to detail.
- Ability to work independently with minimal supervision in a multi-disciplinary team environment.
- Strong CAD/design skills and mechanical aptitude.
- Good interpersonal skills with a growth mindset.
- Adaptable to changing priorities and requirements.
- Ability to wear multiple hats and balance multiple projects.
Compensation, Perks & Benefits
Vesalius Cardiovascular offers an attractive compensation package with health benefits and potential for stock options. In parallel, our engineering lab is centrally located (Broadway Corridor) and is:
- Easily accessible by transit
- In close proximity to full-service gyms, numerous green spaces and restaurants.
- A fun and relaxed work environment with an active and sociable team
Please include a cover letter and any examples of previous design work with your application. Email your application to email@example.com. We’ll contact you if we see a fit.
Thank you for taking the time to apply.
Design Quality Engineer
Our growth has led to an exciting new opening for an experienced Design Quality Engineer and an opportunity to work with a dynamic group of motivated engineers.
We are currently at preclinical stage and in the process of developing a compliant and scalable Quality Management System (QMS).
We are seeking an experienced Design Quality Engineer to work with our team of R&D Engineers and build on the current QMS and Risk Management system. This is an opportunity to work in a dynamic, creative, and highly collaborative environment.
The Design Quality Engineer will be responsible for collaborating with the engineering team to build and drive the design controls program.
The ideal candidate will build and develop a design controls program that will serve as a key engineering tool to inform engineering decisions and ensure compliance to
Under the direct supervision of the engineering lead and continuous clinical guidance from our team of engineers and specialized physicians, the Design Quality Engineer’s responsibilities will include, but are not limited to, the following:
- Building on our current QMS and risk management systems and integrating the design control framework into the company’s workflow based on relevant regulations and guidelines
- Working with the engineering team to drive the QMS design and development plan
- Collaborating with the engineering team to develop design control technical documents, such as User Requirements, Product Specifications, and Risk Management documents
- Providing quality inputs to document & design control activities to mitigate risks and improve patient safety
- Planning, creating, and maintaining the required documents and records for our device’s Design History File
- Developing, managing, and ensuring compliance to the document / engineering change request system
- Producing compliant documents pertaining to device design and manufacturing, including statistical analysis of experimental, test and quality data (e.g. hazard analysis, DOE, gage R&R, risk reports, verification and validation test reports)
- Championing, training, and ensuring adherence to the quality program as design control systems are established
- Supporting technical and design reviews as the Quality representative
The ideal candidate should have:
- A Bachelor’s degree in Mechanical/Biomedical Engineering
- A minimum of 3 years’ experience in design quality / quality assurance engineering in the medical device industry
- Experience with Class IV medical devices
- Strong knowledge of ISO 13485 (7.3) / 21 CFR 820 (section 30), and ISO 14971
- Familiarity with ISO 5840, ISO 5910, and ISO 10993
- Startup experience or experience with New Product Introduction
- Demonstrated leadership and ability to work in a team under minimal supervision to develop a scalable QMS and design controls framework that serves to inform engineering decisions and improves patient safety
- Ability to champion the quality program in a way that ensures compliance and removes or mitigates risk
- Initiative to independently build the design controls framework and conduct research on quality and regulatory requirements for novel concepts and approaches
- Exceptional communication skills and ability to integrate engineering information from the engineering team into the quality system
- Excellent technical writing skills, and strong ability to understand and analyze technical documents
- Excellent problem-solving skills, with a high level of attention to detail
- Ability to perform geometric dimensioning and tolerancing analysis on mechanical assemblies
- Ability to work independently with minimal supervision in a multi-disciplinary team environment
- Good interpersonal skills with a growth mindset
- Eagerness to work with external consultants (i.e. regulatory affairs specialists)
- Adaptable to changing priorities and requirements
- Ability to balance multiple projects
Compensation & Benefits
Vesalius Cardiovascular offers an attractive compensation package with extended health benefits and potential for stock options. Our offices are centrally located in Vancouver, Canada (Broadway Corridor).
Please include a cover letter with your application. Email your application to firstname.lastname@example.org. We’ll contact you if we see a fit.
Thank you for taking the time to apply.