Job Title
Component Development Engineer
Relevant Experience
(in Yrs)
5+ Years
Technical/Functional Skills
Experience in development of medical device components, building device assemblies and instruments.
Change control in a regulated environment (preferably medical device)
Experience in Plastic/Metal Injection molding
Experience in resolving injection molding problems.
Manufacturing and process development experience
Experience with assembly techniques and equipment technologies
Six Sigma Green Belt
Process validation (GMP)
Statistical process control / capability analysis
Measurement system analysis, including GR&R
Risk analysis, including use of FMEA
Engineering drawing interpretation including GD&T fundamentals
Know- how about Product Life Cycle Management
Experience Required
Must have experience in the medical devices industry as well as a basic understanding of the regulatory requirements
Must have experience in Engineering Documentation for medical devices (Product Design & Development Documents, Protocols, Test Reports, MEMOs and Rationales for Engineering Activities)
Experience on equipment/ tool development and qualification
Good knowledge in design program/project approach and governance
Experience in Design verification and Validation
Knowledge of statistical analysis and its applicability to derive engineering rationale
Knowledge of change management plans
Preferred experience with design, engineering and functioning of surgical devices
Development & Conduct of Engineering /Test Studies
Experience in Process Qualification (IQ/OQ/PQ) and Factory Acceptance Testing
Knowledge of Design of Experiments or Process Characterization
Experience in different manufacturing and assembly process, DFMA principles
Experience in custom fixture/gauge design/Fail proof principles
Exposure to trouble shooting and root cause analysis
Preferred experience in process improvement strategies to improve efficiency and throughput
Exposure in automation involving pneumatics/hydraulics/PLC’s
Exposure to Optical Vision based measurement systems
Exposure to Software requirements Development for assembly equipment
Knowledge of Ergonomics and Safety requirements in equipment design
Roles & Responsibilities
- Project management activities, including planning, developing and tracking schedules, and communication
Responsibilities include resolving plastic/metal Injection molding problems.
- Collaborating with cross-functional teams to gain alignment on project plans and testing strategies.
- Coordinating with other projects to determine the product configuration strategy (which version of each product will be tested)
- Authoring and leading the activities (i.e. component development, Engineering built and verification, validation etc.) through the Ethicon change control system
- Driving the activities of each line transfer, including tactical planning and logistics to navigate obstacles
- Coordinating with other team members executing the transfer
- Root cause analysis and troubleshooting for issues post transfer
- Critically reviewing test protocols and reports
- Travel to different Manufacturing plants
Leading or supporting other LCE projects, as needed
Generic Managerial Skills
- Make decisions on the basis of result and outcome in alignment with customer needs
- Meet delivery promise in terms of budget and timescales
- Track Project progress and make necessary changes to project execution as needed to ensure achievement of project goals
- Work within a multi-discipline team, consisting of the R&D and Lifecycle Design and Development engineers, Project Managers, document control specialists
- Liaison with customer designated point of contact and functional area point of contact
- Multiple Project Planning and execution
Education
4 years Degree in Mechanical/ Production Engineering preferred
