job summary :
Responsible for the overall Systems Engineering deliverables and activities including translation of user and business requirements to product requirements, technical approach and system architecture development, harmonization of system design among the relevant products and projects of the segment(s), allocation of derived requirements to subsystems, and integration strategy and methods.
Drives refinement and translation of user requirements (including but not limited to clinical, serviceability, reliability, and manufacturability), regulatory requirements, and system architecture and concepts into functional requirements.
responsibilities :
- You've acquired a minimum of 5 years experience successfully developing complex medical devices and a focus in systems engineering (hardware, software, consumables), with experience in Sleep Therapy / Ventilation products and accessories highly desired.
- You have a strong understanding of System Design process, including Model-Based (MBSE / V-Model) Design approach-conceptualization, writing requirements, functional and technical design, check & optimize, verification, integration and finally validation.
- You have experience in test-Driven design methodologies, analytical and architectural thinking, system view, physical insight, flexibility, and a hands-on mentality to deliver sustainable results and creative solutions.
- You have effective communication, computer, documentation, presentation, and interpersonal skills, as well as the ability to work independently, cross-functionally, and collaboratively.
- You have strong knowledge of Medical Device / FDA Quality System Regulations (ISO 13485 / 14971 / 10993 / 18562 ,17510 2015, IEC 62366 etc.
and clearance processes.
qualifications :
- Experience level : Experienced
- Minimum 5 years of experience
- Education : Bachelors (required)
skills :
- Professional Engineer
Sr. Software Engineer
Inspire Medical Systems complies with applicable laws governing non-discrimination in employment in every location in which Inspire Medical Systems has facilities. Ensure compliance with industry applicable standards for medical devices. Inspire Medical Systems provides equal employment opportunity ...
Manufacturing Quality Engineer (Contract)
Knowledge on Class II/Class III medical device manufacturing and related quality system regulations. Bachelors in Biomedical, Manufacturing, Mechanical Engineering, or related life sciences discipline. Manufacturing Engineer (Contract). Representing Process Engineering in R&D and Project Team meetin...
Senior Software Engineer
Primary Duties & Responsibilities: Key member of software development team for "Digital Health" platform software for medical devices and product solutions within BMT Develop software with best-in-class coding practices to improve workflow efficiency and contrast administration for diagnostic imagin...
System Engineer - Medical Devices
Responsible for the overall Systems Engineering deliverables and activities including translation of user and business requirements to product requirements, technical approach and system architecture development, harmonization of system design among the relevant products and projects of the segment(...
Sr. Product Quality Engineer
Inspire Medical Systems complies with applicable laws governing non-discrimination in employment in every location in which Inspire Medical Systems has facilities. Inspire Medical Systems provides equal employment opportunity (EEO) to all employees and applicants without regard to race, color, relig...
Sr. Product Quality Engineer
Inspire is the first of its kind medical device designed to make a difference in the lives of those living with Obstructive Sleep Apnea (OSA). We are revolutionizing the sleep industry with our FDA-approved medical device, designed to reduce OSA severity for those who cannot tolerate or get consiste...
Senior Systems Engineer
In this role, the System Engineer will integrate multi-disciplinary inputs and outputs to support the definition and development of complex software-controlled electro-mechanical medical device products. The engineer is a key leader in the development and management of support activities such as tec...
Quality Engineer - Post Market Surveillance
Bachelor’s degree in a technical or scientific field, preferably an engineering discipline such as Electrical, Mechanical, Materials or Biomedical. Inspire is the first of its kind medical device designed to make a difference in the lives of those living with Obstructive Sleep Apnea (OSA). We are re...
Principal Systems Solution Engineer
The Principal Systems Solution Engineer position is a key technical leadership role at BMT and will integrate inputs and outputs to support the definition and development of complex software systems involving software services that work with multiple electro-mechanical medical device products. The e...
Sr. Software Engineer
Ensure compliance with industry applicable standards for medical devices . Inspire is the first of its kind medical device designed to make a difference in the lives of those living with Obstructive Sleep Apnea (OSA). We are revolutionizing the sleep industry with our FDA-approved medical device, de...