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

In this cross-functional role, you will actively participate in product development and transfer activities for variable medical devices at Sterling. You will be responsible for guiding teams through the execution of design control activities in alignment with quality system requirements and current best practices to ensure Sterling’s customers products and processes are safe, effective, and meet customer quality and performance needs. You will represent the quality requirements on cross functional core project teams from design control leadership to new product development teams, with ability to work on all components of the system.

Responsibilities

• Provide support for project planning, requirements/specification development, product development, design verification, design transfer, process development, process validation, risk management, human factors, and design validation activities.
• Lead product and process risk management activities.
• Audit the quality and completeness of project design history files.
• Provide consultation to design and process owners with regards to design verification and design validation protocols and reports.
• Act as primary liaison with 3rd party subcontractors who are helping accelerate commercialization of technologies.
• Provide knowledge with respect to the applicable technology to facilitate participation in technical discussions and risk-based decision making.
• Support issue resolution using a risk-based approach.
• Ensure Customer product implementation and validation programs meet regulatory requirements when applicable.
• Provide management with status updates on assigned responsibilities and goals and escalate issues in a timely fashion.

Requirements

• Bachelor’s degree or higher in an engineering or technical science discipline
• Minimum of 5 years of related experience
• Technical expertise in product development
• Experience applying quality regulations and standards (e.g. 21CFR 820, ISO 13485, ISO 14971, IEC62304, and GCP)
• Practical experience in design controls, risk management, verification, validation and change control, and failure investigation tools and techniques
• Applied experience with quality and statistical analysis tools (e.g. SPC, Six Sigma, Risk Analysis, FMEA, DOE, and trend analysis)
• Class II or III Medical device experience
• Highly effective communication, facilitation, coaching, and negotiation skills
• Adaptable to fast-paced, dynamic work environment with shifting demands
• Demonstrated ability to accomplish goals while working across departments is required

Company is in Concord and Woodbridge, Ontario - must be local to Toronto during work.

Profile 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.