Senior Clinical R&D Engineer

Analog Devices, Inc. (NASDAQ: ADI) is a global semiconductor leader that bridges the physical and digital worlds to enable breakthroughs at the Intelligent Edge. ADI combines analog, digital, and software technologies into solutions that help drive advancements in digitized factories, mobility, and digital healthcare, combat climate change, and reliably connect humans and the world. With revenue of more than $12 billion in FY23 and approximately 26,000 people globally working alongside 125,000 global customers, ADI ensures today’s innovators stay Ahead of What’s Possible. Learn more at www.analog.com and on LinkedIn.

Responsibilities and Candidate Profile:

• Must have a broad understanding of human physiology and knowledge of biophysical and biochemical phenomena enabling a non-invasive detection of biomarkers of interest.
• Will engage with external stakeholders (clinicians, researchers, and customers) to uncover insights and turn clinical application requirements into clear technical requirements.
• Will lead the definition, investigation and testing of medical devices including Pre-Clinical testing (GLP), Design Validation Testing and Human Factors Testing. Additionally, will have responsibility for leading third-party engagements for clinical trials.
• Will provide technical and clinical guidance to programs from concept development through regulatory submission by defining clinical validation strategy and protocols for studies.
   

Minimum Qualifications

• MS or PhD degree in Biomedical Engineering or Clinical Engineering, or EE/ME/CS with Biomedical Focus, with a minimum of 3 years of relevant experience.
• Medical device use or development (familiarity with Design Control activities and Design Verification and Validation testing, Human Factors testing) OR clinical experience in a medical or preclinical testing setting of medical devices.
• Scientific research capability/experience (hypothesis generation and testing, R&D experiment execution).
   

Preferred Qualifications:

• The ideal candidate has prior experience in designing and testing optical (e.g. pulse oximetry), biopotential (e.g. ECG), and/or bioimpedance (e.g. EDA) vital signs monitoring devices and applications. A strong knowledge of systems physiology is a plus.
• Performing lab analysis and evaluation of new medical products, working with a multi-functional team to identify, simulate, and correct functional and parametric problems.
• 5+ years of clinical engineering in the medical device industry.
• Strong presentation and technical documentation skills.

ADI is an equal opportunity employer. Applicants are considered for employment without regard to race, color, religion (including religious creed), sex (including pregnancy), gender, national origin, age, sexual orientation, marital status, gender identity or expression, ancestry, disability, medical condition, genetic information, veterans, and/or military status and any other categories protected by applicable law.

For positions requiring access to technical data, Analog Devices, Inc. may have to obtain export  licensing approval from the U.S. Department of Commerce - Bureau of Industry and Security and/or the U.S. Department of State - Directorate of Defense Trade Controls.  As such, applicants for this position – except US Citizens, US Permanent Residents, and protected individuals as defined by 8 U.S.C. 1324b(a)(3) – may have to go through an export licensing review process.

Analog Devices is an equal opportunity employer. We foster a culture where everyone has an opportunity to succeed regardless of their race, color, religion, age, ancestry, national origin, social or ethnic origin, sex, sexual orientation, gender, gender identity, gender expression, marital status, pregnancy, parental status, disability, medical condition, genetic information, military or veteran status, union membership, and political affiliation, or any other legally protected group.