StarFish Medical has an opening in Toronto, ON, for a New Product Introduction (NPI) Engineer who brings experience working with the complexities of product development in a regulated industry. Reporting to the NPI Manager, the NPI Engineer will work closely with both the Manufacturing and Product Development teams to develop manufacturing processes and procedures, support design transfer, and execute manufacturing validation in the medical device field.
The successful NPI Engineer will utilize their industry knowledge and expertise to ensure an efficient and effective process is followed for final design and transfer of products to Manufacturing. Your knowledge of fabrication, assembly, tooling and materials and your proven communication and relationship building skills will enable you to thrive in the NPI Engineer role.
StarFish Medical offers the NPI Engineer:
- The opportunity to work on cutting edge technology
- Satisfaction of improving the quality of life for others through medical device technology
- An organization with strong culture core values
- A team oriented/collaborative environment
- An award winning company culture & tight knit team
- Profit sharing
- Competitive compensation
- Excellent medical benefits package
- Monthly All-hands meetings
- Active social committee
- TTC/Transit subsidy in Toronto
Responsibilities of the NPI Engineer include:
- Develop, evaluate, improve, and validate manufacturing processes following GMP and StarFish Medical’s QMS by understanding product and process requirements and applying knowledge of product design, fabrication, assembly, tooling, and materials.
- Work professionally with both internal and external clients to deliver products to meet their business and regulatory needs.
- Continually improve transfer procedures and systems through liaison with the Product Development team to ensure that resulting design and processes are robust and well designed for manufacturing, assembly, and test, while adhering to project budget.
- Support the Manufacturing Team by leading technical troubleshooting efforts related to electromechanical systems including Sustaining Engineering activities as well as the NCR and ECR/ECO implementation processes.
- Support the Manufacturing team in efforts to minimize the impact of non-conformances, vendor management, incoming inspection processes, and RMA defects resolution.
- Develop, build, and qualify appropriate manufacturing tooling, including hardware and software installations, assembly test fixtures/jigs, and test equipment, as required.
- Conduct training and provide guidance and supervision for Production Technicians on assembling, testing, troubleshooting, and repair techniques for electromechanical equipment.
- Improve manufacturing efficiency by analyzing and planning workflow, space requirements, and equipment layout while meeting manufacturing process, product, and quality assurance requirements.
- Develop and update manufacturing work instructions, device master records, and other documentation as required and implement approved changes through StarFish Medical’s QMS.
- Assure product and process quality by designing testing methods and establishing standards to verify manufacturing process capabilities.
Qualifications and Abilities of the NPI Engineer:
- Bachelor degree (or equivalent) in a relevant Engineering discipline (e.g. mechanical, electrical, mechatronics, electronics or similar), or an equivalent combination of relevant coursework and work experience.
- 3 Years of experience supporting manufacturing for electromechanical devices.
- FMEA and Lean Manufacturing experience.
- Previous experience working in a regulated environment (ISO 13485,FDA, etc.) and following a Quality Management System.
- Experience in DFM and DFA principles and application is considered an asset.
- Demonstrated experience at all stages of the development life cycle for electromechanical devices.
- Excellent communications skills, both verbal and written.
- Strong planning, relationship building, and negotiation skills are required to create win/win situations for our customers and our company.
- Innovative problem solving skills and proven adaptability.
About StarFish Medical:
StarFish Medical, Canada’s premier medical device development group, is an integrated team of 100+ technical product development professionals who work on device design projects for North American and international customers.
You will work with some of the best design strategists, designers and engineers in North America to help direct, create and deliver cutting edge products for international medical device markets. Our project areas range from tactical EMS products, surgical tools and consumer diagnostic devices through to high volume disposables, complex IVD systems, imaging technologies and lab equipment.
In our surveys, 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. If you want to be a part of the innovation and excitement of StarFish Medical, we encourage you to apply!
How To Apply:
Qualified NPI Engineer applicants are encouraged to apply through the brand new StarFish Medical Job Portal with a resume and cover letter that clearly indicates how your education and experience meet the requirements of this position.
We thank all candidates who apply; however after initial acknowledgement, only those selected for further consideration will be contacted.