Current Opportunity

Mechanical Design Engineer

Full time

Location: Concord, ON

Engineering @ 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 designer with extensive experience in designing tooling, gauges, and fixtures, as well as providing support in DFM/DFA to enhance customer product design. This individual will critically evaluate project requirements, specifications, and plans to oversee the design and installation processes. 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 concept development, prototyping and product design, testing and design iteration
  • 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
  • Apply and provide DFM/DFA principles
  • Creating engineering documentation (models, drawings, specifications, documents, etc)
  • Participate in and/or lead technical discussion internally or externally, be able to justify designs based on engineering principles, calculations, empirical testing, etc
  • Participate in product testing, performance evaluation and certification activities
  • Design and create mechanical and electrical assembly jigs and fixtures as well as assistant tool for metrology measurement such as CMM and others

Requirements and Education:

  • A minimum of 10 years’ experience in engineering, product development, and testing, with a strong background in plastic injection molding design. End of Arm tooling (EOAT) design experience 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 of TS16949 or ISO9001 and ISO 13485 systems
  • 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.

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.

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Dale Morgan, Director of Global Quality at Sterling Industries

Dale Morgan

Director of Global Quality

Dale is our Director of Global Quality. He brings a career’s worth of experience and leadership in Medical Devices, with deep expertise in quality management systems, regulatory submissions, quality engineering, and more.  Dale has worked with both established medical device OEMs and start-ups, as well as product certification and audit organizations. A licensed professional biomedical engineer, Dale is also certified as an ISO 13485 auditor/MDSAP.

Tim Doyle | Quality Manager, U.S. Operations

Tim Doyle

Quality Manager, U.S. Operations

As Quality Manager of our U.S. Operations, Tim brings over 30 years of experience in computer-aided surgical devices, electromechanical devices, metal fabrication and assembly processes, including clean room assembly and packaging for sterilization. He has extensive international experience, partnering on quality and supplier development projects. Tim holds the ASQ CQE designation. He also proudly served 7 years in the United States Air Force.

Patrick Tam | Quality Manager, Canadian Operations

Patrick Tam

Quality Manager, Canadian Operations​

Patrick serves as Sterling’s Quality Manager, bringing over 20 years of Quality Systems Management experience in the Medical Device and Pharma industries. He leads our Quality Management proactive, bringing a tactical and strategic focus to ensure consistent, repeatable quality for our clients. Prior to joining Sterling, Patrick served as Quality System Manager at Integra LifeSciences where he was responsible for maintaining Quality in their Canadian operations.

Jeff Kiel | Manager, Engineered Solutions

Jeff Kiel

Director of Engineered Solutions

Jeff serves as Director of Engineered Solutions. He works closely with clients to evolve and refine their Medical Device designs — sometimes from the idea stage — through to a fully-optimized, scaleable, ready-to-ship product. He uses his engineering and technical expertise to design our production processes. Prior to joining Sterling, Jeff worked with Toyota in their Prototype Weld Group.

Libni Cano is our Toronto operations’ Regulatory and Quality Manager, responsible for quality and regulatory.

Libni Cano

Regulatory and Quality Systems Manager​

Libni serves as Regulatory and Quality Manager for Sterling’s Canadian sites, responsible for both quality and regulatory compliance. She has over 14 years of experience in medical device quality management systems, with expertise in FDA and Health Canada regulations as well as electronic QMS implementation. Libni is a BSI-certified Lead Auditor for ISO 13485:2016.; she is also ASQ certified with CQE and CMQ designations, and holds a BSc in Industrial and Systems Engineering.

Ronitt is our Director of Business Development with 25 years of experience, and is responsible for Sterling Industries' global business development.

Ronitt Katz

Director of Business Development

Ronitt serves as Sterling’s Director of Business Development, bringing 25 years of experience. She has an extensive background in the tech industry, having worked for IBM, TIBCO and several software companies, from startups to industry leaders. Within the Medtech space, She has vast experience in partnering with Fortune 100 organizations, early stage startups, and everything in between.

Jojo Wang is our Engineering Manager, responsible for leading our Sterling Engineering Team.

Jojo Wang

Director of Engineering

As Director of Engineering, Jojo is responsible for leading the Engineering Team. She brings a wealth of experience in Project Management, Lean Manufacturing, and Product Development, and expertise in designing manufacturing solutions and driving business improvements. Prior to joining Sterling, Jojo served as a process engineering leader for Boston Scientific, focused on electrophysiology solutions. She holds a BSc in Mechatronic Engineering & Automation, and a Masters in Engineering Management.

Lilian So is the Director of Finance here at Sterling Industries.

Lilian Soo

Director of Finance & HR

Lilian is the Director of Finance & HR at Sterling. She is a seasoned professional with over 15 years of progressive experience in Finance, and a talented CPA/CGA who unites operations with finance continuously improving company performance. She has extensive experience with fast paced environment, driving innovations and process improvements to help drive positive changes and optimize profitability.

John Pleskina is the Director of Global Operations for all our facilities, responsible for manufacturing operations.

John Pleskina

Director of Global Operations

John is the Director of Global Operations for Sterling, responsible for manufacturing operations. John has over 25 years manufacturing experience in a variety of leadership roles, most recently as VP of Manufacturing at Southmedic Inc.  Previously, John was Director of Operations for Scapa Healthcare where he was responsible for the effective operation of sites in Canada, the U.S. and the U.K.  A graduate of the University of Waterloo, John served over 14 years with the Royal Canadian Navy.

David Van Slingerland, CEO of Sterling Industries

David Van Slingerland

CEO

David assumed the role of CEO in 2007 and has led Sterling Industries through transformative growth. He brings over 30 years of executive experience, with deep expertise in change management and growing organizations through innovative technology and human capital. At Sterling, he has introduced an agile manufacturing model, built an industry-savvy leadership team, and is responsible for driving customer-focused end-to-end solutions. Prior to Sterling Industries, David held a variety of executive positions with Manulife Financial and Shoppers Drug Mart.