- Responsible for overall product technical success
- Develop user and product requirements and specifications for system based on user needs, product and process regulatory standards.
- Compiles and evaluates design and test data, prepares technical specifications, and determines appropriate limits and variables for product, process, or materials specifications.
- Develop design inputs based on inputs from other functional engineering groups.
- Analyze product requirements and other technical specifications to determine if product is performing to requirements.
- Develop system architecture
- Achieve best practices that meet medical device industry standard, including design control and documentation
- Interface with product team members, mechanical and electrical engineers, manufacturing or design transfer engineer, R&D, marketing, regulatory (internal).
- Analyzes, develops, and recommends design approaches required to meet design and production requirements for new or enhanced device.
- Manage traceability between design inputs, design outputs, and verification and validation
- Stay up-to-date and follow all Quality System procedures related to this job, which can affect the quality of products or services provided to our customers.
- Bachelor's degree in Engineering or Science; Master's degree is an asset
- Minimum five years' relevant experience and/or training related to systems engineering
- Knowledge of medical device technology, applicable quality and safety standards, and regulations ( In particular ISO 60601-x)
- Demonstrated ability to deal with a fast-paced environment, high levels of ambiguity, multiple concurrent projects, and conflicting assignments
- Demonstrated initiative, attention to detail, customer focus, and commitment to ongoing process improvement
- Experience with requirements specification and traceability
- Knowledge of product lifecycle management
- Experience with project management a plus
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System Engineer - Schaumburg, United States - Recooty
Description
Position will lead system engineering efforts for Class I medical devices.Company is remediating all DHFs to align with EU MDR, new QMS and latest standards of Risk management, Usability engineering, biocompatibility etc.
Lead engineer will take technical ownership of product group and work with mechanical, electrical, test engineers, design transfer engineering team to create DHF/Technical file artifact compliant to QMS.
Responsibilities:
Skills Required:
