R&D Engineer II – Medical Device Innovation & Validation

Teleflex; Kamunting; Vor Ort; MYR 60.000 - 90.000; Vollzeit

Zusammenfassung

Teleflex Medical is seeking an engineer to lead validation and development activities across materials, packaging, and finished devices. You will coordinate with marketing, clinical, regulatory, operations to document user needs and design transfer.

The role requires problem solving, data analysis (Cpk/DOE/SPC), and cross-functional collaboration in a fast-paced environment. With 2-4 years in manufacturing or medical device manufacturing, you will create DHF/DMR documentation, support regulatory

Qualifikationen

• Undergraduate degree in engineering/material science; graduate degree preferred.
• 2-4 years in manufacturing/medical device environment considered.
• Fluent English in oral and written form; strong analytical skills.
• Proficient with data analysis tools and standard software.

Aufgaben

• Develop, validate, and coordinate materials/packaging or finished product validation activities.
• Support Front End Innovation activities including market research and concept development.
• Own and deliver project documentation and design transfer outputs.
• Coordinate with cross-functional teams to document user needs and design inputs/outputs.
• Create and maintain DHF/DMR documentation and project charters.
• Lead development of validation plans, test methods, and statistical analyses (DOE, SPC).
• Assist with regulatory submissions and audits as needed.
• Travel domestically and internationally as required.

Kenntnisse

Analytical skills

Team player

Strong communication

MS Office

Minitab

Problem solving

Good English

Ausbildung

Engineering/Materials Science degree

Graduate or advanced degree preferred

Tools

Microsoft Office

Minitab

Jobbeschreibung

Teleflex Medical is seeking an engineer to lead validation and development activities across materials, packaging, and finished devices. You will coordinate with marketing, clinical, regulatory, operations to document user needs and design transfer.

The role requires problem solving, data analysis (Cpk/DOE/SPC), and cross-functional collaboration in a fast-paced environment. With 2-4 years in manufacturing or medical device manufacturing, you will create DHF/DMR documentation, support regulatory