The Systems Engineer will be a key participant in many steps along the product development pathway, including system requirements development and documentation, development testing, design verification testing, Design History File compilation, validation and iterative improvement processes.
Essential Duties And Responsibilities
- Perform system level testing
- Investigate issues found during development, testing, and/or from the field
- Collaborate with Hardware, Software and Mechanical Development, Marketing, Technical Services, and other project team members to ensure schedules and requirements are consistent with project expectations
- Create/assist other development groups (software, hardware, electronics) with requirements to align with system level requirements and to maintain consistent format
- Contribute to FDA 510(k) submission development or other regulatory filings as assigned
- Ensure compliance with FDA device regulatory requirements
- Train individuals involved in verification and validation activities as needed
Requirements
The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- BS Degree in Engineering
- Knowledge of testing and documentation of medical products
- Ability to handle multiple tasks while ensuring timely and accurate completion
- Knowledge of testing and documentation of medical products
- Proficient in developing test plans, protocols/test scripts, result reports
- Good understanding of requirements testing and traceability methodology within the product development life cycle
- Proven participation and leadership with cross-functional teams
Education And Experience
- Bachelors Degree in and Engineering Discipline
- 0-2 years of experience of system engineering in the medical device industry
For roles based in the United States that require access to hospital facilities, must be eligible for and maintain credentials at all required hospitals, including meeting any applicable physical requirements or vaccination requirements (including the COVID-19 vaccine, as applicable).
ATEC is committed to providing equal employment opportunities to its employees and applicants without regard to race, color, religion, national origin, age, sex, sexual orientation, gender identity, gender expression, or any other protected status in accordance with all applicable federal, state or local laws. Further, ATEC will make reasonable accommodations that are necessary to comply with disability discrimination laws.
Salary Range
Alphatec Spine, Inc. complies with state and federal wage and hour laws and compensation depends upon candidate's qualifications, education, skill set, years of experience, and internal equity. $82,000 to $95,000 Full-Time Annual Salary
