Component Development Engineer

Job Title

Component Development Engineer

Relevant Experience

5 Years

Technical/Functional Skills

Experience in development of medical device components, building the device assemblies and instruments.
Exceptional project management skills
Excellent communication and collaboration skills
Change control in a regulated environment (preferably medical device)
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
Bilingual (English/Spanish) is preferred
Know- how about Product Life Cycle Management
Experience Required

Ø Must have experience in the medical devices industry as well as a basic understanding of the regulatory requirements

Ø Must have experience in Engineering Documentation for medical devices (Product Design & Development Documents, Protocols, Test Reports, MEMOs and Rationales for Engineering Activities)

Ø Experience on equipment/ tool development and qualification

Ø Good knowledge in design program/project approach and governance

Ø Experience in Design verification and Validation

Ø Knowledge of statistical analysis and its applicability to derive engineering rationale

Ø Knowledge of change management plans

Ø Preferred experience with design, engineering and functioning of surgical devices

Ø Development & Conduct of Engineering /Test Studies

Ø Experience in Process Qualification (IQ/OQ/PQ) and Factory Acceptance Testing

Ø Knowledge of Design of Experiments or Process Characterization

Ø Experience in different manufacturing and assembly process, DFMA principles

Ø Experience in custom fixture/gauge design/Fail proof principles

Ø Exposure to trouble shooting and root cause analysis

Ø Preferred experience in process improvement strategies to improve efficiency and throughput

Ø Exposure in automation involving pneumatics/hydraulics/PLC’s

Ø Exposure to Optical Vision based measurement systems

Ø Exposure to Software requirements Development for assembly equipment

Ø Knowledge of Ergonomics and Safety requirements in equipment design

Roles & Responsibilities

Project management activities, including planning, developing and tracking schedules, and communication
Collaborating with cross-functional teams to gain alignment on project plans and testing strategies