Biomedical Engineer

Position: Biomedical Engineer ("BE")

Biomedical Engineer (“BE”) in charge of complete product development for Theralase’s medical laser systems (“Products”); including: concept to commercialization research, design, development, safety, efficacy, testing, packaging, labelling, system integration, regulatory approval, documentation and Standard Operating Procedures (“SOPs”) 

Reports to: Engineering Manager 

Duties and Responsibilities:

  • Meet with engineering and senior managers to understand and develop a detailed Product specification to achieve: design intent, performance, safety, efficacy, robustness, reliability, stability, cost and timing for engineering and senior manager review and approval prior to finalization 
  • Write detailed design specification in compliance with ISO-13485: 2016 Design Review (Design Control, Design Inputs, Design Outputs, Design Verification and Design Validation) (Hardware, Firmware, Software, Mechanical, Packaging, Labelling), Failure Mode and Effect Analysis (“FMEA”) and SOPs to present to engineering and senior management for review and approval prior to commencing design 
  • Design and develop electronic schematics, Bill of Materials (“BOMs”), firmware, Computer Aided Design (“CAD”) and Computer Aided Machining (“CAM”) data, Printed Circuit Board (“PCB”) layout, Gerber files, Electro Magnetic Interference (“EMI”) minimization, SOPs, test fixtures, operating manuals, final test documentation, quality control documentation, packaging, labelling and external testing specifications for the manufacture, assembly, testing, troubleshooting and service of the Product 
  • Optimize the Product for: design intent, safety, efficacy, robustness, reliability and stability throughout the design process to achieve Product specifications 
  • Create project plans and monitor daily progress to objectives providing formal written 1 to 2 page executive summary reports weekly to present to engineering and senior managers on project status, cost and timing 
  • Research, develop and write Engineering Protocols for engineering technologists to complete testing to generate raw testing data 
  • Research, develop and write Engineering Test Reports to verify and validate design intent, safety and efficacy performance of the Product prior to launch 
  • Monitor customer satisfaction, design intent, safety and efficacy performance of the Product in the field 
  • Research, design and implement version-controlled engineering changes to Products to eliminate customer concerns, meet design intent, optimize safety and efficacy performance during incoming inspection, sub-contract manufacture, manufacture, final test, quality control, quality assurance or customer use in the field using formal engineering methodologies: 8 Discipline Report (“8D”) process, Corrective Action / Preventative Action (“CAPA”) methodology and Engineering Change Document (“ECD”) 
  • Provide Product support for Engineering, Production, Sales, Marketing and Service teams 
  • Optimize and validate updates to legacy Products using formal engineering methodologies 
  • Write engineering specifications for external contracted resources and successfully manage and document their performance to complete all required objectives, milestones, developing and implementing version-controlled Prodcuts to meet / exceed the project objectives, cost and timing 
  • Design all Products to achieve Mean Time To Failure (“MTTF”) of greater than 10,000 hours continuous use and uptimes in excess of 99.99% 
  • Manage and coordinate the successful testing, quality control and regulatory approval of the Products, in compliance with ISO-13485: 2016, CSA, UL, Health Canada, ISO, FDA, GMP and CE guidelines 
  • Ensure flawless transition from engineering to production through organized and detailed project documentation and hands-on training 

Skills and Qualifications Required: 

  • Ability to achieve and/or surpass engineering and senior management defined biomedical engineering objectives; including: design intent, performance, safety, efficacy, robustness, reliability, stability, cost and timing 
  • University bachelor’s degree in biomedical or electrical engineering with 5+ years of hands-on engineering experience (hardware, firmware, software) designing, developing, implementing and optimizing medical devices from concept to commercialization 
  • Professional Engineer (P.Eng.) designation preferred 
  • Hands-on experience with electrical laboratory instrumentation and troubleshooting/debugging hardware, firmware and software 
  • Able to fully document Product through schematics, BOMs, PCB layout, Gerber files, assembly instructions, SOPs for manufacture, test, calibration, final test, quality control, labelling, packaging, shipping and service 
  • Able to research, design and develop Product using ISO-13485: 2016 design review guidelines 
  • Ability to accurately estimate scope, cost and timing to prioritize and deliver on Product objectives 
  • Ability to evaluate and clearly communicate (written and verbal) technology concepts and ideas to engineering and senior managers and colleagues 
  • Participate in defining and validating requirements 
  • Finalizing design specification 
  • Computer literate in Microsoft suite of products (i.e.: Office, Excel, Outlook, Word, Power Point) 
  • Problem solving and resolution skills using formal engineering methodologies (i.e.: 8Ds, CAPA, Statistical Process Control (“SPC”), Design of Experiments (“DOE”), FMEAs 
  • Strong oral and written communication skills in the English language 
  • Ability to learn, remain calm and focus on the timely completion of objectives 
  • Organized, self-motivated and professional in dealing with colleagues and senior managers 
  • Self-starter with the ability to work independently under minimal supervision. 
  • Team player with a proven ability to build positive relationships at all levels of an organization 
  • Ability to prioritize in multi-tasking environment with excellent attention to detail and accuracy 
  • Enjoy working in a challenging and fast growth environment 
  • Flexible and accountable working in a team environment 
  • Positive, “Can-Do” attitude and strong belief in personal accountability 
  • Strive to constantly improve and develop skills both personally and in assisting their colleagues to do the same 

Compensation:

$70,000 to $90,000 base, commensurate with experience + performance bonus + employee benefits (after 3 months) + stock options, subject to board of director approval. 

Theralase® is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. Theralase® is also committed to compliance with all fair employment practices regarding citizenship and immigration status.

 

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