5+ to 7 years experience
* Bachelor of Engineering or Science Degree with a strong technical background within Systems Engineering, medical device development, or similar roles.
* 5 years proven experience.
* Ability to work in a team with global teamwork and interacting with external development partners.
* Excellent communication and written skills with attention to detail.
Desirable Qualifications:
* Experience in multiple areas within Systems Engineering such as; requirements development and management, system architectural planning and design, interface control, systems integration and characterization testing.
* Experience interpreting experimental results, performing statistical analysis or DFSS (Design for Six Sigma) techniques and FMEA methods is a plus.
* Experience with requirements management tools such as Microsoft Azure/Modern Requirements is a plus.
* Experience in development to IEC 60601 and IEC 62304 standards is a plus.
Main responsibilities will include:
* Plan through all project phases, strategy and execution of product development, design verification and validation.
* Has a strong background in electromechanical medical device, IVD or lab automation design and development.
* Can translate multiple design inputs from User Needs, Regulatory, Quality, Marketing, Product Security etc., into product requirements, specifications and detailed trace matrices.
* Can critically assess the design and test implications for product requirements and specifications.
* Responsible for coordination of system-level product development; requirements, architecture, integration and system characterization testing.
* Can challenge design proposals and prototypes through robust design reviews.
* Concisely communicates technical challenges and possible solutions and manages key decisions and tradeoffs.
* Guides in identifying key system behavior issues and driving the implementation of their solutions for new and existing products.
* Establishes courses of action and plans for self and others to ensure that work is completed efficiently.
* Develops and sustains productive business relationships on a global front.
* Shares Systems Engineering knowledge expertise with junior level team members and other functional areas as domain specialist.