Tata Consultancy Services • Blue Ash, OH • Posted 2 days ago via LinkedIn
Tailored resume, cover letter, and cheat sheet
Using AI ⚡ to summarize the original job post
The Component Development Engineer at Tata Consultancy Services is responsible for the development of medical device components, building device assemblies, and instruments. This role involves change control in a regulated environment, experience in plastic/metal injection molding, resolving injection molding problems, manufacturing and process development, assembly techniques, and statistical process control. The ideal candidate will have a strong understanding of the medical devices industry, regulatory requirements, and engineering documentation for medical devices.
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
Responsibilities include resolving plastic/metal Injection molding problems.
Leading or supporting other LCE projects, as needed
Generic Managerial Skills
Education
4 years Degree in Mechanical/ Production Engineering preferred
Search for other jobs like this one:
Search for popular related roles:
Search nearby locations hiring for this role: