Sr. Mechanical Engineering

Full-time | On-Site

Location: Woodbridge, ON

Engineering at Sterling Industries

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.

Job Description

The successful candidate will be a strong mechanical engineer with extensive experience in medical device product development, tooling design, gauges, and fixtures, as well as providing support in DFM/DFA to enhance customer product design. The role demands responsibility for ensuring that all designed tooling, gauges, and fixtures meet the outlined specifications and requirements, are delivered within budget constraints, and adhere to project timelines. Additionally, the designer will occasionally take on new engineering projects, where they will need to identify requirements and outline the necessary steps for implementing new designs or modifying existing products.

Primary Duties and Responsibilities:

• Lead or assist in medical device concept and design development, prototyping, testing and design iteration
• Support customers on product design and development, including plastic design, sheet metal, and machining for various applications, ensuring manufacturability and performance.
• Conduct DFM & DFA reviews with internal teams and customers.
• Design and develop high-precision fixtures, jigs, and gauges to support assembly, inspection, and manufacturing processes
• Perform tolerance analysis and ensure GD&T is correctly applied.
• Conduct prototype evaluations and testing to validate design integrity.
• Create and maintain 3D models, drawings, BOMs, and mechanical simulations in SolidWorks
• Reading and understanding technical documentation, including customer drawings, specifications, design criteria and datasheets
• Collaborate with suppliers and customers to evaluate material availability and cost.
• Design and develop high-precision fixtures, jigs, and gauges to support assembly, inspection, and manufacturing processes
• Work with mold makers and suppliers to ensure tooling feasibility, gate placement, and part ejection strategies.
• Design and develop custom EOAT (End-of-Arm Tooling) solutions for robotic automation systems (pick-and-place, handling, packaging, etc.).
• Develop and maintain engineering documentation, including DHF (Design History File) and DMR (Device Master Record).
• Work closely with cross-functional teams, including engineers, program managers, quality and regulatory, and manufacturing teams.
• Support quotations, sales, and order management, assembly, and manufacturing departments from a design, documentation, and troubleshooting standpoint.
• Participate in and/or lead technical discussions internally and externally, justifying designs based on engineering principles, calculations, and empirical testing.
• Participate in product testing, performance evaluation, and certification activities.
• Creating engineering documentation (models, drawings, specifications, documents, testing protocols, etc)

Requirements and Education:

• A minimum of 10 years’ experience in engineering, medical device product development, and testing, with a strong background in plastic injection molding design and material selection.
• End of Arm tooling (EOAT) design experience with a focus on automation is desirable.
• Expert proficiency in SolidWorks/CAD, including drafting, Design for Manufacturing (DFM), Design for Assembly (DFA), and a proven understanding of GD&T 14.5Y, tolerance definitions, and tolerance stack-up analysis.
• Demonstrated ability to conceptualize, quote, and execute production-related tools and equipment.
• Hands on experience in designing and building fixtures / jigs/ and process supporting tools
• Experience in providing engineering support for production equipment and tooling troubleshooting, along with a collaborative approach to problem-solving.
• Excellent documentation, organizational and time management skills
• Supplier engagement, including verification processes, relationship building, and maintenance.
• A tenacious problem-solver who leaves no stone unturned – exploring every possibility to its appropriate end in order to find the best design solution.
• Practical skills with the ability to modify and create physical and functional prototypes using basic hand tools and shop equipment.
• Knowledge ISO9001 and ISO 13485 and FDA 21 CFR 820.
• Ability to work on several projects simultaneously with attention to detail
• Ability to work independently
• Excellent English language communication skills (both verbal and written)
• Preference for individuals with tooling and machine / automation design experience

5 Core requirements:

1. Mechanical design, DFA/DFM knowledge within a medical device product development environment using SolidWorks
2. Medical device product development through prototyping and testing
3. Plastic injection molding and fixtures design experience
4. Strong analytical and problem-solving aptitude with attention to detail.
5. Excellent English language communication skills (both verbal and written)

Sterling Industries is an equal opportunity employer. If you require an accommodation, please notify us and we will work with you to meet your needs.