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.
This positions is responsible for the launch and daily management of the processes, products, equipment, people and customers in regard to the quality management system and regulatory requirements.
Development and implementation of all quality related processes and documentation for new program development and current sustainment business.
- Direct involvement in manufacturing process development and continuous improvement as to meet or exceed the company’s quality metrics and process metrics for current and new business.
- Review, analysis, and resolution of customer/internal/supplier quality issues through root cause analysis and implementation of corrective actions.
- Development and implementation of preventative actions and continuous improvements within the manufacturing and quality areas.
- Control of the non-conformance area (inventory, disposition, and associated costs)
- Purchase, management and review of gage equipment, certifications and calibrations. Including programing CMM or other coordinate measurement equipment.
- Ensure the Gage calibration log is complete and up to date.
- Coordinate with the quality inspector for the daily inspection, measurement, test, and approval of all components, product, process and use of quality metrics to ensure quality targets are met.
- Communicate and coordinate with management, administrative, operations, quality, and engineering departments.
- Daily use of quality management system software and SPC systems.
- Participate in conducting supplier and internal system and process audits.
- Engineering bachelor’s degree, with technical and mathematical focus preferred.
- 3-5 years’ experience in a quality department in an ISO registered environment
- High volume workload requires conscientious attitude with accuracy and attention to detail.
- Knowledge and experience on: ISO 9001 (ISO 13485 a plus), . process capability and effect on processes, production, equipment, and assembly), problem solving methods (5Y, Fishbone, 8D, etc.), ability to be self-managed and directed from a satellite operation
- Six Sigma certifications a plus (green belt or higher)
- Proficient in with Microsoft office (outlook, excel, word, power point)
- Good communication skills (oral, written, technical)
- Excellent time management skills and the ability to be self-directed
- Customer focus and continuous improvement approach.
- Experience with machining, fabrication, and assembly operations a plus
- Must be able to work a flexible schedule and lift minimum 40 pounds.
- The position will require some travel (USA and Canada).
Full time employees are offered a comprehensive benefit package including:
- Health care through Priority Health
- $1,000 deductible plan,
- $4,500 deductible plan
- Dental through Delta Dental
- Vision through Eyemed
- Long term disability and $20k life insurance through Mutual of Omaha
- 401K (90 days)
- 1:1 match up to 5% of annual income
- 2 weeks paid vacation
- Goes to 3 weeks after 5 years
- Goes to 4 weeks after 10 years