The Mechanical/Assembly Engineering Team within Global Operations and Technology which supports the development of transformative integrated medical products. These products span from medical imaging, wearable sensing, in vitro diagnostics, and other high value applications. As our products evolve beyond integrated circuits into full-system medical solutions, this role will provide distinguished technical leadership to strengthen existing capabilities and develop new competencies in medical-grade mechanical design, assembly engineering, process development, prototyping, manufacturing, and qualification in close partnership with our Business Units.
The successful candidate will have a history of designing and bringing differentiated products to market within the medical device industry. Experience in mechanical construction, board-level and subsystem- level mechanical design, as well as a strong understanding of microelectronic/electronic assembly, is highly desired. Experience managing outsourcing partners to support the product development process, as well as bringing up the manufacturing process through qualification and commercialization is required. This candidate must be energetic, collaborative, proactive, and able to multitask effectively.
ResponsibilitiesThe successful candidate will:
- Work independently with minimal supervision in engineering and product development environments.
- Work with industrial designers, system architects, marketing engineers, and customers to understand product requirements and best practices.
- Have experience with medical device construction techniques including printed circuit assembly, plastics and higher-level device assembly.
- Have knowledge of and the ability to leverage existing, medically proven state-of-the-art technologies when possible.
- Translate requirements into innovative, differentiated, and manufacturable design concepts in accordance with DFM practices.
- Lead mechanical design reviews, FMEAs, and technical trade-off discussions with stakeholders from other disciplines such as systems, electrical, packaging, reliability, and assembly engineering.
- Help secure design wins via the development of Minimum Viable Products (MVPs).
- Collaborate with ADI's Global Operations organization to establish manufacturing guidelines and requirements to convert MVPs into commercial products.
- Apply a thorough understanding of verification and validation to demonstrate fulfillment of mechanical requirements.
- Ensure that task execution complies with product development requirements in a regulated sector.
Example product concepts include wearables for wellness and clinical grade applications, disposable diagnostics, and medical imaging modules. The position will require
Qualifications & RequirementsRequired:
- Advanced degree in Mechanical, Electrical Engineering, or a related discipline.
- Minimum 10 years of experience in medical product development and an ability to demonstrate 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
- Mechanical design experience with a practical eye for manufacturing compatibility and cost effectiveness.
- Experience with medical-grade products involving mechanical components, materials, flexible substrates, and circuit card assemblies.
- 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.
- Extensive experience with SolidWorks and/or 3D CAD tools
- Knowledge of circuit board stack-up and layout processes
Desired:
- 5+ years of project management experience.
- Knowledge of the FDA regulatory process and/or experience with an FDA approved medical device.
- Knowledge of regulatory requirements such as ISO 13485, IEC 60601, etc.
- Knowledge of assembly processes like surface-mount circuit board assembly and high-level product assembly (HLA)
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.
Job Req Type: Experienced
Required Travel: Yes, 10% of the time
Shift Type: 1st Shift/Days
The expected wage range for a new hire into this position is $157,080 to $227,460.
- Actual wage offered may vary depending on work location, experience, education, training, external market data, internal pay equity, or other bona fide factors.
- This position qualifies for a discretionary performance-based bonus which is based on personal and company factors.
- This position includes medical, vision and dental coverage, 401k, paid vacation, holidays, and sick time, and other benefits.
