Current Opportunities

PRODUCT DEVELOPMENT ENGINEER

Under the supervision of the Director of Engineering, the Product Development Engineer will be responsible for the conceptual development, detailed design, prototype fabrication, and verification of novel medical devices, fixturing, and tooling.

Responsibilities

The Product Development Engineer responsibilities will include, but are not limited to, the following:

  • Establish design specifications to meet overall device requirements.
  • Initiate and develop relationships with 3rd party vendors, contractors and manufacturers.
  • Verification testing of designs, from concept to finished product.
  • Prototype development (fine-scale assemblies, micro-machining, model building).
  • Documentation development that includes (but is not limited to) engineering drawings, specifications, protocols, test reports, work instructions, and quality inspections.
  • Planning and periodic reporting of activities and progress.
  • Managing projects.

Qualifications/Experience

The ideal candidate should have:

  • Bachelors Degree in Mechanical Engineering. Biomedical specialization is a plus.
  • A minimum of 3 years in the medical device industry or equivalent.
  • Very strong design skills using parametric modeling software (Solidworks)
  • Experience in structural-heart (specifically mitral valves) related medical devices is considered a very strong asset.
  • Start-up experience (working in a fast-paced environment) is a plus.
  • Familiarity with design and testing requirements of medical devices (ISO 13485, ISO 5840, ISO 5910).
  • Machine shop experience, experience with CNC machines, lathes, drills, grinders, etc.
  • Experience in medical device assembly and sewing techniques is a plus.

Abilities

  • 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.
  • Must be able to work with minimal supervision in a multi-disciplinary team environment (self-motivated, able to self-manage, strong desire to succeed).
  • Strong CAD/design skills and mechanical aptitude.
  • Familiarity with sewing techniques and product integration.
  • Good interpersonal skills including: maturity, respect, courtesy, tact, discretion.
  • Must be able to operate under changing priorities and requirements.


QUALITY ASSURANCE ENGINEER

The Quality Assurance Engineer will be an advocate for quality medical devices development for the entire organization, focusing on the Design Controls and Risk Management.

Under the supervision of the Director of Engineering, the Quality Assurance Engineer will be responsible for the overall design & development, implementation, and maintenance of the organization’s Quality Management System (QMS). Additional responsibilities will include developing and executing tests, investigating and assisting in problem analysis, and resolving quality issues related to the development of product lines.

Responsibilities

The Quality Assurance Engineer responsibilities will include, but are not limited to, the following:

  • Initiate, document, and maintain the corporate wide Quality Management System (QMS).
  • Lead or support Risk Management (in accordance with ISO 14971) evaluation of new products being developed.
  • Help establish both design control and risk management documents in compliance with applicable standards.
  • Set up a suitable supplier qualification and management program.
  • Ensure the strategy for document and records management is well-defined and implemented.
  • Deploy and maintain training matrices of the corporate Quality Documents.
  • Handle multiple projects and tasks, from product inception through product launch and maintenance.
  • Play an active role in the processes to ensure products meet quality standards and are consistent with the QMS.
  • Help establish manufacturing inspection, sampling, and statistical process control methods and procedures to assure quality of manufactured products.
  • Assure compliance to in-house and external specifications and standards.
  • Identify and highlight quality issues by providing input to drive corrective actions to problems identified.
  • Perform/lead root cause analysis to determine corrective action(s), as necessary.
  • Lead in the development of Failure Mode and Effects Analysis (FMEA).
  • Train internal staff on latest quality techniques.

Qualifications

The ideal candidate should have:

  • Bachelors Degree in Mechanical Engineering or related Science. Master’s is a plus.
  • 3+ years in the quality (design controls) and/or regulatory medical device industry or equivalent.
  • Strong knowledge, understanding and experience with implementing ISO quality management system for medical devices (ISO 13485:2016) and US FDA Quality System Regulation (21 CFR 820).
  • Experience in structural-heart (specifically mitral valve) related medical devices is considered a very strong asset.
  • Working knowledge of risk management skills and requirements (e.g. FMEA and ISO 14971).
  • Experience as Auditor of internal and external quality management systems is considered a plus.
  • ASQ, CQE or CQA certification is an asset.
  • Project Management experience.
  • Start-up experience (working in a fast-paced environment) is a plus.

Abilities

  • Excellent technical report writing and strong ability to understand and analyze technical documents.
  • Exceptional communication and interpersonal skills, with the ability to comfortably communicate at various levels in the organization, both internally and externally.
  • Proven abilities in project and time management to ensure completion of tasks on a priority basis.
  • High level of critical thinking and problem-solving skills.
  • Self motivated with a strong work ethic.
  • Proficient with reading engineering drawings, written specifications, production documentation, using calibrated inspection equipment such as gauges, calipers, microscopes, manometers, pull test and other inspection equipment.
  • Demonstrated knowledge in Quality System Regulations.

How to apply

Email a cover letter and CV to hr@vesaliuscardio.com.

We'll contact you if we see a fit. Thank you for taking the time to apply.

Vesalius Cardiovascular Inc, 2016