The Senior New Product Development Manufacturing Engineer (Sr. Engineer, Manufacturing) is responsible for the development of manufacturing processes for new medical device product development projects. The position is well-suited to someone who has experience developing the manufacturing processes for new medical devices and seeks latitude to exercise creativity and judgment in an organization that is at the start of developing its medical device process development infrastructure.
- Developing manufacturing processes to support medical device product development projects
- Collecting information to prospectively evaluate quality, cost, delivery, and management of contract manufacturing partners
- Supervising and collaborating with contract manufacturers in the selection and development of manufacturing processes
- Collaborating with partners in legal to develop contracts and conducting engagements with suppliers
- Orchestrating DFMA reviews to provide input to design firms and design engineers
- Collaborating with cross-functional product development teams including project managers, optical engineers, mechanical engineering, electrical engineers, software engineers, quality engineers, regulatory specialists, clinical specialists, marketers, buyers, and others
- Development and maintenance of manufacturing work instructions, equipment instructions, and other documents that require quality management system controls
- Designing and documenting manufacturing cells using tools such as value stream maps, balance charts, and line layout diagrams
- Complying with medical device manufacturing regulations and quality procedures and providing input into the development of these procedures
- Supporting engineers in developing material specifications by providing manufacturability input
- Coordinates technical communications between Canon and contract manufacturers including facilitating professional engagements for DFX, process development, and design transfer
- Monitors and develops processes to monitor manufacturing performance on an ongoing basis to ensure quality, productivity, and delivery.
- Creating manufacturing development infrastructure (e.g. templates for process characterization and labor time estimation, etc.)
- Provides technical expertise in conducting PFMEA and developing process validations
- Evaluating non-conformances
- Coordinating builds for prototypes, validations, and pilot runs.
- Shares expertise in Lean Six Sigma process excellence principles
- Embrace Canons kyosei philosophy and embody the san-ji spirit
- Travel about 20%
- Other duties as assigned
- Education: Bachelors degree in engineering or higher required
- At least 7 years of experience in medical device manufacturing engineering
- At least 3 years of experience in new product development manufacturing engineering including time working with contract manufacturers
- Experience working with optics assembly and manufacturing processes, electronics testing, and catheter manufacturing is highly preferred
- Ability to successfully execute responsibilities without operations infrastructure in place (i.e. no ERP system, SOPs are being developed, no pre-existing operations organization), but must have experience with these systems
- Proficiency in developing technical drawings and specifications
- Proficient in the application of Lean Six Sigma principles
- Proficient in the use of CAD, preferably SolidWorks
- Strong proficiency with Excel, PowerPoint, Project, Visio, and Word
About our Company - Canon U.S.A., Inc., is a leading provider of consumer, business-to-business, and industrial digital imaging solutions to the United States and to Latin America and the Caribbean markets. With approximately $36 billion in global revenue, its parent company, Canon Inc. (NYSE:CAJ), ranks third overall in U.S. patents granted in 2017 and is one of Fortune Magazine's World's Most Admired Companies in 2018. Canon U.S.A. is committed to the highest level of customer satisfaction and loyalty, providing 100 percent U.S.-based service and support for all of the products it distributes in the United States. Canon U.S.A. is dedicated to its Kyosei philosophy of social and environmental responsibility. In 2014, the Canon Americas Headquarters secured LEED® Gold certification, a recognition for the design, construction, operations and maintenance of high-performance green buildings. To keep apprised of the latest news from Canon U.S.A., sign up for the Company's RSS news feed by visiting www.usa.canon.com/rss and follow us on Twitter @CanonUSA. For media inquiries, please contact [email protected].
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