Development Emerging Technologies - NPI Test Leader

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SHL Medical is the world-leading solution provider in the design, development, and manufacturing of advanced drug delivery systems with more than 5000 employees worldwide. Our customers include top pharmaceutical and biotech companies from around the globe that require innovative devices such as auto injectors or pen injectors to effectively deliver their drugs. Headquartered in Switzerland since late 2018, with sites in Sweden, Taiwan, and the Unites States.

Job Overview

As a Senior NPI Test Lead in our Development Emerging Technologies department (DET), you will play an important role on successful implementation of future electrical and electro-mechanical medical device development programs.

During the design and engineering phase, your mission is to cooperate with design and other teams to define test plans, process them and then ensure the execution of these tests.

You will cooperate and coordinate all activities internally, with external electronics suppliers, development partners, and PCBA manufacturers.

Main Responsibilities

· Take ownership of the entire NPI test system and related documentation in collaboration with process developers and quality engineering team

· Develop product testing requirements and test-sequences for active medical devices including electromechanical autoinjectors, gateways, IoT add-ons and other medical devices

· Team up with quality engineers and manufacturing to analyze production testing failures and to continuously improve production testing yields

· Monitor key parameters and CQA on the production line using statistical methods and 6 sigma and DOE approaches

· Support to monitor production yield data (yield-bridge) and deep dive into test related issues with a systematic approach for resolution or improvement. Meanwhile, implementing continuous test enhancements to improve quality

· Drive and resolve engineering/production issues, including process, hardware, and test issues

· Actively participate in risk assessments and the product design providing recommendations and suggestions before the project’s sample build.

· Study and propose opportunities for DFM (manufacture), DFC (cost), DFT (testing), DFA (assembly) and DFS (sustainability) improvements

· Partner with process developers on developing test fixtures required by the manufacturing testing and on setting up manufacturing test environment & system test stations for a given product.

· Develop and sustain test hardware & software. Define a robust test framework to ensure product quality by driving the highest test coverage according to the system development spec.

· Develop and maintain documentation on processes or procedures to maintain ISO13485 compliance

Skills and Qualification

· Degree in Engineering, Applied Sciences or similar

· 5+ years of relevant industry experience in assembly testing of electromechanical devices

· Demonstrated understanding of all aspects of testing requirements for various electronic products (ideally active medical devices)

· Experienced in constructing professional in-line quality test specifications, test setup, and test reports.

· Established engineering capabilities in debugging production testing failures with effective engineering fixes for resolving/improving related problems.

· Strong capability in troubleshooting with engineering team on manufacturing related issues with various test systems

· Good understanding of quality, reliability, and compliance requirements

· Ability to navigate through ambiguities and concepts and realize it to practical process or flows.

· Ability to communicate effectively and professionally across a range of technical disciplines.

· Ability to take on difficult challenges and communicate across organizational boundaries.

· Professional written, verbal, and presentation skills in English and in Chinese with the ability to effectively communicate with the stakeholders.

Preferred qualifications:

· +3 years of experience in leading technical projects/teams, serving as a subject matter expert in testing domain area.

· +3 years of experience providing technical leadership and leading projects (e.g., test, release, etc.) in a complex, matrixed organization.

· Experience in engineering and manufacturing of active medical devices

· Equipment, process, and software validation experience

We Offer

· An exciting opportunity in a fast-growing international medical device company

· A modern working environment, with multicultural and dynamic teams

· Flexible working hours and a hybrid remote work policy

· Various opportunities for personal and professional development within a global organization