Norwood, United States
7 months ago
The Hardware Systems Architect - Engineering will help will help the team design, develop and commercialize new medical device products.
Perform advanced system engineering tasks for an electromechanical point-of-care medical device, including systems architecture development, requirements, interfaces, systems engineering processes.
Provide input into medical device and future device iterations - develop concepts and requirements documents.
Enhance requirements communication between teams engaged in the engineering and acquisition functions. Develop and implement new processes as appropriate. Create and maintain major program documents, such as Systems Engineering Plans
Lead the development of new requirements for medical device systems, focusing on how medical systems are designed, manufactured, and tested.
Involved with program integration such as organizing integrated product team meetings, systems reviews, and interagency discussions and documentation creation.
Execute processes to ensure baseline control and provide leadership to the Configuration Management, Data Management, and Data Architecture teams.
Mandatory Skills Requirement: Minimum, a BS in an Engineering discipline, with experience focused in systems engineering & 14-16 years of qualified experience OR Masters in Mechanical Engineering Field) discipline & 10 years of qualified experience Proficient in Systems Engineering processes and methods as applied to electromechanical medical device design and methods, architecture and configuration, including interfaces between subsystems
Requires demonstrated initiative, sound judgment, and effective decision-making. Applicant will also be able to demonstrate excellent written and verbal communication skills, ability to work with others in a team setting, and proficiency with MS Office products to include Project, Power Point and collaborative software products such as MS SharePoint.
- Drives and guides the creation of a functional architecture for a complete system and of technical realization concept over all its domain and technical aspects
- Evaluates different concepts with respect to technological and commercial aspects
- Specifies and integrates standard products, components, and subsystems according to the required functionality of the system and coordinates their interfaces and interaction
- Verifies and validates the concepts and specifications versus the requirements and standards
- Provides feedback and lessons learned to the Engineering organization and R&D department
- Acts internally as an integrating and coordinating technical function
- May draft the integration test concepts
- May take over dispositive functions or responsibility for costs, time and quality
- Is expected to adopt existing concepts, methodologies, etc. in order to create and open up new ways of approaching and fulfilling specific internal and external client requests or project requirements.
- Develops technological concepts as input for system and solution development.* Monitors system performance in the prototyping, test and verification phase. * Supports the commissioning phase with the customers, and analyzes potential malfunctions.* Indentifies and defines technical requirements for realizing alternative applications.* Evaluates different build in concepts, with respect to technological and commercial aspects. * Ensures observance of specifications.* Creates respective reports. "Creates"Is expected to adopt existing concepts, methodologies, etc. in order to create and open up new ways of approaching and fulfilling specific internal and external client requests or project requirements. "Senior Professional"Positions which need senior professional expertise, with extensive functional, commercial and/or technical knowledge in an area of competence. They integrate analysis, development, testing and implementation. They interpret and functionally influence policy and guidelines in their area of business / technology, and develop processes and systems to deliver functional objectives. They typically plan own work according to targets agreed, within an quarterly up to an annual cycle, by integrating resources in a project driven environment. They provide functional advice and guidance to colleagues and customers. A chartered professional qualification or equivalent is typically associated with grades (though not necessary). 8-10 years Deep professional know-how and experience in one Sub Job Family. Masters domain. Transfers and applies know-how to / in various contexts. Solid professional judgment and problem solving competence. Improves existing processes and approaches.