职位描述

Who we want:

Sets direction.  An innovator who defines ways to create value and deliver on Stryker’s mission and strategic imperatives.

Builds organizational capability.  A strategic executive who continuously breaks down barriers, identifying new and more effective ways to accomplish tasks and goals.

Inspires others.  A genuine, relationship-focused leader who connects, collaborates and fosters an inclusive environment of enthusiasm, trust and pride. He/she makes others want to follow, building momentum for action and positively influencing outcomes.

Champions talent development.  A manager who focuses on maximizing the ability, potential and contributions of themselves and others.   Fosters an environment where people can excel through developing, coaching and rewarding performance.

Delivers results.  A driven player/coach who sets high goals for personal achievement and organizational success.  He/she measures success against the best internal and external benchmarks.

What you will do:

• Bachelor’s /Master’s Degree in Mechanical Engineering

• Minimum of 6-8 years experience with medical devices sold in the EU/US

• Strong working knowledge of EU regulations including experience with developing and preparing submissions for EU Notified Bodies (Technical Files and Design Dossiers)

• Knowledge/Working experience on US FDA/China NPMA is preferred

• Experience with orthopedic devices is preferred

• Prior experience collaborating in cross-functional development teams providing feedback as the RA representative

• Prior experience working on new EU Medical Device Regulation implementation projects and/or large enterprise projects desired

• Knowledge on ISO 14971/ISO 10993 standards

What you need:

• Excellent written/verbal communication skills

• Awareness of standards used in design and manufacture of Orthopedics Medical devices such as but not limited to ISO 10993-1/ ISO 14971/ ISO 15223-1

• Knowledge on New product development process and its phases preferred