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’s 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 be patients around the world, Sterling is the place for you.
We are seeking an eager Manufacturing Engineering Specialist to join our growing team. The role will work to develop, plan, and execute new designs in addition to process and design changes for current products.
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.
Key Responsibilities include:
- Work closely with the business development group and clients to develop and analyze technical and design aspects of new development opportunities under business review.
- Follow and coordinate with assigned project team for product development (scoping, business case, development, testing, and launch) analyze key project metrics.
- Establish key project metrics (product cost, project costs, schedule) and take appropriate action.
- Mentor and influence product development engineering co-oop students.
- Review technical inquiries of customers to recommend and quote relevant system discuss possible new applications when needed.
- Develop new or improved methods, products, techniques.
- Advance understanding of material resources and new processes.
- Plan, develop and perform product testing.
- Facilitate design control process as defined by the quality management system.
- Lead DFMEA and PFMEA process and documentation as required.
- Evaluate the results of FEA analysis to certify new product safety and performance.
- Complete quality requirements for equipment and process validation.
- Root cause and sustain current operational equipment and processes.
- Team member and resource for CAPA process.
- Produce engineering drawings and inspection criteria as required.
- Provide relevant and timely information regarding project to management.
- Enter business system information as required for ERP/QMS using approved process.
- Present findings and updates in written and verbal formats to senior management and customers as required.
- Contact customers and/or suppliers to obtain and exchange information and/or decisions on design and application.
- Foster an environment of innovation with the submission of innovative ideas.
- Make recommendations for productivity and method improvements.
- Work within approved quality management system procedures.
- Bachelor of Science in engineering or equivalent engineering certifications.
- Experience with CNC programming, machining processes, and equipment preferred
- Experience in launching new products and/or processes
- Knowledge of process capability, problem solving methods, and root cause/corrective actions.
- Familiar with ISO 9001 (internal auditor certifications and/or ISO 13485 familiarity a plus).
- Ability to work well with cross functional teams, be self-managed and detailed oriented
- Great communication skills.
- The position may require some travel (USA and Canada).