Position Summary:

Responsible for designing, documenting, and verifying the product.

Authorities:

· Has the authority to identify and record problems relating to product and component design and to recommend or provide solutions. Interface with contract manufacturers, engineers and technicians. Interface with vendors, order parts, materials. Support Manufacturing and R&D goals.

Duties and Responsibilities:

· Design and develop product(s) in full compliance with the company’s Design Control requirements and consistent with FDA QS Regulation, ISO, MDD, CE Mark, and Canadian Medical Devices Regulations.

· Responsible for ensuring proper documentation consistent with company’s quality system.

· Responsible for knowing and planning activities consistent the company’s quality policy and quality objectives.

· Responsible for ensuring the lab notebooks are documented in a timely manner and consistent with the applicable SOP.

· Develop solutions to design problems through the application of engineering principals, analysis, and empirical methods

· Model complex components and assemblies in CAD and create detailed drawings.

· Build and test prototype designs for proof of concept.

· Develop protocols and perform product verification and validation testing.

· Perform process-related design tasks to support pilot manufacturing.

· Support production of final product by troubleshooting manufacturing processes.

· Identify suppliers and maintain relationships to ensure the delivery of superior components and services.

· Enhance the intellectual property position of the company via invention disclosures and patent applications.

· Maintain current knowledge of competitive technologies in addition to medical, technical, and biomedical developments related to company’s products.

· Maintain GMP systems, including pre-production quality assurance procedures, pre-clinical testing programs, and post production GMP compliance in coordination with the Document Control, Clinical, and Quality Assurance functions.

· Responsible for component documentation

· Support company goals and objectives, policies and procedures, Good Manufacturing Practices, and FDA regulations.

· Maintain clean and orderly work/ lab space.

Position Requirements:

· Must possess good interpersonal and communication skills, and work in a collaborative style.

· Good technical skills and proven engineering problem solving ability.

· Experience using CAD tools (SolidWorks preferred).

· Strong understanding of engineering materials, component selection, and design for reliability and manufacturability.

· Able to perform engineering design analysis such as FEA, FMEA, dFMEA, and tolerance stack-up analysis

Education Requirements:

· Bachelor’s Degree in Mechanical/Electrical or Biomedical engineering

Experience Requirements:

· Minimum of one year of experience in engineering preferably in the medical device and/or pharmaceutical.

Special Requirements:

· Able to perform In-Vitro and In-Vivo testing for R&D development

Preferred Requirements:

· NONE

Note: This job description is an outline of the major recurring responsibilities of the job/position. It is not intended to be all-inclusive of the work to be performed. Other related job objectives, special assignments and less significant responsibilities will typically be performed by the incumbent. Incumbents will follow any other instructions, and perform any other related duties, as may be required by their supervisor.