Full-time
Location: Woodbridge, ON
Engineering @ Sterling
They say good engineers love solving puzzles. Every day, our team figures out how to build and improve our clients’ innovative MedTech solutions, manufacturing them at scale, ready to improve patients’ lives. It is a mission that requires multi-disciplined, creative, and flexible minds, working together for our clients’ success. Whether it is process, mechanical, or quality control engineering, every member plays an important role, making our team stronger. If you want to put your engineering skills to work on delivering the next generation of medical devices to patients around the world, Sterling is the place for you.
About Sterling Industries
Established in 1984, Sterling Industries provides end-to-end contract manufacturing and assembly of medical devices and components to Fortune 100 OEMs, as well as mid-size medical device OEMs and fast-growing “scale-ups.” Registered with the U.S. FDA and Health Canada, Sterling helps clients deliver successful products through its vertical integration, managing the entire process, including the supply chain, manufacturing, assembly, testing, labelling, packaging and shipping. The company operates from facilities in the suburban Toronto (Concord and Woodbridge) and Kalamazoo, Michigan. Sterling manufactures success.
Overview
The Electrical Engineer is responsible for producing designs, test and design specifications and to test and document the electrical/electronic designs, following the Company’s ISO 13485:2016 Quality Management System. They are responsible for resolving all electrical/electronic issues to meet component and system specifications. They are responsible for determining and facilitating third party certifications of all electrical aspects of the Company’s electromedical devices. The Electrical Engineer is expected to provide technical leadership with many aspects of the overall design of the Company’s products. This includes reviewing their peers’ design and those already developed by the Company and suggesting improvements to them.
Duties and Responsibilities
- Participate in the generation of electromedical device Subsystem requirements and specifications
- Carry out electrical/electronic engineering design activities including design, debug, modifications and verification of electrical components of the products
- Develop the manufacturing testers and test procedures
- Create the BOM for electrical assemblies and printed circuits
- Develop and document circuit schematics
- Support the layout of printed circuits
- Participate in or lead design reviews by providing expertise in hardware designs.
- Reviewing existing designs or new designs developed by peers or external contractors.
- Develop and maintain Hardware Language designs for Programmable Logic devices.
- Lead hardware improvement projects as required by the business.
- Follow Sterling PDLC and Design Control and Change Procedures and maintenance of Design History Files.
- Develop test methods to qualify the products by working with test laboratories/Agencies or in house
- Ensure the device’s electrical safety and participate in risk management activities
- Support prototype and product manufacturing activities as needed
- Responsibility for preparing all test-related equipment necessary for conducting tests and validations as needed
- Investigate product complaints, perform root cause analysis of failures, and propose remediation in a timely fashion
Qualifications
- Bachelor’s degree in electrical engineering or a related field. A master’s degree is preferred but not mandatory
- Minimum of 10 years of experience in electrical engineering, preferably in product design and development in medical device industry, & 2+ in technical leadership position
- Sound knowledge of electronics engineering design principles for analog, digital, signal processing, power electronics, and RF designs.
- Proven track record of working on projects for system integration, software/firmware development is an asset.
- In-depth knowledge of relevant industry standards and regulatory requirements (e.g., IEC – 60601-1, IEC-60601-1-2, National/International Product Certification ) and Design and testing for EMC; Medical Product Risk Management (ISO 14971:2019)
- Proficiency in electrical design software such as AutoCAD Electrical, Altium Designer, OrCAD, or similar tools
- Strong knowledge of circuit design, schematic capture, and PCB layout
- Experience with simulation and analysis tools like SPICE, MATLAB, or similar
- Familiarity with embedded systems and microcontroller programming
- Experience with prototyping, testing, and validating designs – waterfall and V-model approaches.
- Ability to develop and execute test plans to ensure product reliability and performance
- Proficiency with testing equipment such as oscilloscopes, multimeters, signal generators, and spectrum analyzers
- Experience in setting up and maintaining a test environment, including configuring and calibrating testing equipment
- Proficient in creating detailed technical documentation, including design specifications, test reports, and user manuals
- Ability to maintain accurate records of design changes and updates – familiar with ISO 13485 design and development documentation requirements.
- Demonstrate high degree of innovation to achieve high quality, usefulness and cost-effectiveness
- Strong analytical and problem-solving skills with the ability to diagnose and address technical issues efficiently
- Strong organizational skills and attention to detail
- Able to work well in teams and independently
- Excellent written and verbal technical communications skills
The company is located in Concord and Woodbridge, Ontario – must be local to Toronto during work.
J. Sterling Industries will consider and provide accommodations throughout the recruitment, selection and/or assessment process to applicants with disabilities. If selected to participate in the recruitment, selection and/or assessment process, please inform Sterling of the nature of any accommodation(s) that you may require in respect of any materials or processes used to ensure your equal participation. All information collected will be protected under applicable privacy requirements.
We will review applications as they are received. Only qualified applicants will be contacted.
