Do you enjoy working in an open-concept environment where ideas among like-minded professionals are routinely exchanged with enthusiasm and support? Do you want to work within this atmosphere, collaborating as an integral part of the Manufacturing team, working directly with Product Development, while focusing on supporting ground-breaking advancements in medical engineering? Are you excited by the idea of being hands on in the manufacturing transfer process? If so, we may have found the perfect job for you!
We have an exciting opportunity for an experienced Manufacturing Engineer to work with project teams on leading-edge products that add to Starfish Medical’s world-renowned medical device portfolio. This rare opportunity will provide the right candidate with challenges enabling you to grow your skills, knowledge and experience as you work on interesting and innovative client projects. A typical year at StarFish Medical means hands-on involvement with multiple projects for medical devices that meet various international regulatory standards in conformance with Starfish’s Quality Management System.
About StarFish Medical
StarFish Medical is Canada’s premier medical device development group, an integrated team of 80+ technical product development professionals located in Victoria, BC and Toronto, Ontario. The group focuses on innovative & creative device design solutions for North American and international customers. Our projects range from tactical emergency medical service products, surgical tools and consumer diagnostic devices through to high volume disposables, imaging technologies and lab equipment. At any given time, our engineers work on a wide variety of concurrent projects.
Our head office in beautiful Victoria, BC, Canada, will provide you an energizing, purpose-designed 20,000+ sq. ft. facility with some of the best medical device design strategists, designers and engineers. You will be part of a team that helps direct, create and deliver exciting product experiences for varied device markets. In a recent survey, our employees rated peers and culture, interesting and meaningful work, and working conditions (flexibility, environment) as the top reasons they most enjoyed working at StarFish.
The Senior Manufacturing Engineer reports to the Director of Manufacturing, working closely with both the Manufacturing and Product Development teams to deal with the complexity of medical device design to include Manufacturing methods and procedures, Manufacturing Quality, and DFM. The Manufacturing Engineer will use their leadership skills and expertise to ensure efficient and effective process is followed for final design and transfer of products to Manufacturing.
- Own the DMR for products in manufacturing and in development.
- Work professionally with clients to deliver products to meet their business and regulatory needs
- Evaluate, establish, improve, and qualify manufacturing processes following GMP and StarFish Medical’s QMS by understanding product requirements and applying knowledge of product design, fabrication, assembly, tooling, and materials.
- Continually improve transfer procedures and systems through liaison with the Product Development group to ensure that resulting design and processes are robust and well designed for manufacturing, assembly and test within allocated budgets from products transferring
- Develop, implement, and transfer of manufacturing processes and procedures for new product introductions and continuous manufacturing improvement opportunities.
- Support the Manufacturing Team by leading technical troubleshooting efforts related to electromechanical systems including Sustaining Engineering activities.
- Support the Manufacturing team in efforts to improve the NCR defects, Vendor Management and Incoming Inspection processes.
- Develop, build, and qualify appropriate manufacturing testing stations including hardware and software installations, assembly test fixtures/jigs, and other test equipment as required.
- Conduct training and provide guidance and supervision for Production Technicians on assembling, testing, troubleshooting, and repair techniques of electromechanical equipment.
- Improve manufacturing efficiency by analyzing and planning work flow, space requirements, and equipment layout while meeting manufacturing process, product, and quality assurance requirements.
- Provide inputs to the product development staff for continuous improvement initiatives for product manufacturability and serviceability.
- Develop and update manufacturing work instructions, device master records, and other documentation as required and implement approved changes through StarFish Medical’s change control process.
- Assure product and process quality by designing testing methods and establishing standards to confirm manufacturing process capabilities.
- Assist during internal/external audit process.
- Minimum of Bachelor degree (or equivalent) in a relevant Engineering discipline or equivalent education gained through work experiences.
- Minimum 5 years’ experience with manufacturing techniques involved with electromechanical systems (within regulated industry preferred).
- Knowledge of GMP and experience working in an ISO 13485 environment strongly preferred.
- Experience & knowledge in Electro Mechanical Engineering, FMEA, Lean Manufacturing, DFM, DFA principles and applications.
HOW TO APPLY:
Qualified applicants are encouraged to apply in confidence to email@example.com with a covering letter and resume that clearly indicates which position you wish to be considered for, and describes exactly how your education and experience meet each of the requirements of this position, as well as your salary expectations.
We thank all applicants who apply; however only those selected for consideration will be contacted.