Sr Techical Leader: R&D

JOB SUMMARY:
Leads projects in the design and development of Implantable Medical Devices and accessories and related manufacturing processes. The individual designs, tests, integrates, documents and validates new or modified devices and processes. The individual coordinates interdepartmental and or external resources by use of sound project management techniques to achieve companywide objectives. S/he requires an ability to function effectively under compressed timeline pressures and to manage difficult or complex projects.
KEY DUTIES AND RESPONSIBILITIES:
Comprehends and defines R&D requirements to develop and design new Implantable medical devices and design changes /enhancements for existing products. Assist other engineers for specifying and procuring various components. Provides technical information in the form of written specifications.
Designs, tests, documents, implements and validates device designs, equipment and processes.
Leads and Assists other engineers for specifying and procuring materials and equipment for the manufacturing site.
Support Operations, Quality, Manufacturing, Technical Support departments and contract manufacturers to develop and implement cost effective manufacturing equipment and procedures.
Is responsible for transferring of equipment and new processes to the manufacturing site and ensure smooth start up within quality and cost constraints. Assist other engineers to develop and design precision tooling and equipment for assembly of Medical Devices.
All other functions inherent to the position such as supporting change control, audits, CAPAs, complaint investigations, Regulatory and Marketing inquiries and related testing or data generation, and other tasks as assigned by the immediate superior.
Education and Experience
Bachelors or higher degree in Engineering or Industrial Engineering, Chemical Engineering, or related degree.
Minimum 9 years of experience in the medical device industry required; or equivalent combination of training and experience is required
Advanced degree desired but not required
Other Professional Skills:
Fluent English Speaker (C1)
Knowledge Quality Management Systems/Regulations (GMP, QSR, FDA, CAPA, ISO)
Microsoft Office, Minitab desirable, Solidworks or AutoCAD desirable.
Medical device, manufacturing experience required, and design control knowledge and development process knowledge are preferred.
Knowledge of plastics / rubber parts / silicone design and processing methods preferred.
Knowledge of materials design, materials testing, and related physical / chemical characterizations of material properties is preferred.
Technical writing skills.
Risk Management knowledge including FMEA, desirable.
Knowledge on equipment qualifications and process validations.
Understanding of the principles of Design for Manufacturability and testability is preferred.Ability to function in a controlled environment regulated by FDA GMPs and handle confidential data required.
Ability to work with flexible schedule to meet deadlines

Employment type
Full-time

Work arrangement
Hybrid