Senior Mechanical 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 FY22 and approximately 25,000 people globally working alongside 125,000 global customers, ADI ensures today’s innovators stay Ahead of What’s Possible.

Description

The Digital Healthcare Business Unit at Analog Devices develops transformative products ranging from medical imaging to wearable sensing and in vitro diagnostics.  As our products evolve from integrated circuits to higher levels of full-system solutions, we seek a hands-on builder with technical fluency to execute and help plan medical-grade mechanical design, prototyping, manufacturing, and qualification, in collaboration with our Global Operations organization.  This role will support activities across Digital Healthcare.  

The successful candidate will have demonstrated ability in defining, designing, and driving to market differentiated products within the medical device, wearable, or biotechnology industries.  Expertise is required in both mechanical and fluidic domains.  This candidate will leverage and expand on a network of proven third party contractors & suppliers.  They must be energetic, collaborative, proactive, and able to multitask effectively.

Responsibilities

The successful candidate will:

• Utilize CAD, rapid prototyping and product development practices to  realize and evaluate models and prototypes of new to the world medical modules, systems, and devices.
• Work with industrial designers, system architects, marketing engineers, health-care providers, and customers to understand product requirements pertaining to mechanical and fluidic domains
• Translate requirements into innovative and differentiated manufacturable design concepts in accordance with DFM practices
• Establish IP and define modelling strategies of these concepts
• Participate in mechanical design reviews, FMEAs and technical trade-off discussions with stakeholders from other disciplines such as systems, electrical, packaging, reliability & assembly engineers
• Have knowledge of & leverage existing, medically proven state-of-the-art technologies when possible
• Keep up with state-of-the-art developments in medical devices and fluidic systems
• Help secure design wins via development of Minimum Viable Products (MVPs)
• Evaluate capabilities and identify rapid prototyping/ manufacturing partners
• Collaborate with ADI’s Global Operations organization to establish manufacturing guidelines/requirements to convert MVPs into commercial products.
• Accelerate product development by hiring and exercising network of contractors
• Ensure execution of tasks complies with requirements for product development in a regulated sector

Example product concepts include wearables (for wellness and clinical grade), disposable diagnostics, and medical imaging modules.  The position will require 10-15% travel.

Qualifications & Requirements

Required:

• Advanced degree in Mechanical Engineering, Biomedical Engineering, or a related discipline.
• 3+ years experience in medical product development demonstrating an understanding of how the mechanical aspects integrate with other disciplines such as biology, reliability, and electrical engineering
• Demonstrated record of innovation, execution, and results, with high standards for performance
• Familiarity with mechanical and thermal design of products interfacing directly with skin, blood, etc.
• Knowledge of regulatory requirements such as ISO 13485, IEC 60601, etc.
• Knowledge of the FDA regulatory process and/or experience with a FDA approved medical device
• Strong teamwork, inter-personal and communication skills coupled with a demonstrated ability to work at a high level of performance both independently and collaboratively
• High levels of motivation and creativity, with an outgoing, positive attitude, and inquisitive nature

• Expertise in products involving both mechanical (e.g. Flexible substrates) and/or fluidic functions (e.g. pumping and valving).
• Experience with medical device regulations and best practices in wearables

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.

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