Canon’s Healthcare Optics Research Laboratory, located in Cambridge, MA, is currently seeking a Medical Device Senior Manufacturing Engineer (Sr Engineer, Manufacturing) to be 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.

This position is full time and offers a hybrid work schedule requiring you to be in the office three days per week and an option to work from home two days per week. Note that work schedules and office reporting requirements may change from time to time based on business needs.

Responsibilities:

– 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

and sites

– 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

– Developing and maintaining 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

– Coordinating technical communications between Canon and contract manufacturers, including design transfer

– Developing 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.)

– Providing technical expertise in conducting PFMEA and developing process validations

– Evaluating non-conformances

– Coordinating builds for prototypes, validations, and pilot runs

– Sharing expertise in Lean Six Sigma process excellence principles

Qualifications:

– Bachelor’s degree in an engineering discipline required

– At least 5-7 years of experience in medical device manufacturing engineering

– At least three years of experience in new product development manufacturing engineering, including time working with

contract manufacturers / vendors

– Experience working with optics assembly and manufacturing processes, electronics testing, and catheter manufacturing is

strongly preferred

– 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