Senior Systems Engineer

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

• Collaborate with business and other internal stakeholders (clinical research, operations, etc.) to define user needs, with emphasis on capturing and articulating user requirements effectively to the team.

• Perform system level testing as needed
• Investigate issues found during development or testing
• Create System level requirements
• Directly manage projects to drive clear timelines that are executed on time and on budget.
• Create/assist other development groups (software, hardware, electronics) with requirements to align with system level requirements and to maintain consistent format.
• Lead FDA 510(k) submission development or other regulatory filings as assigned.
• Assist/mentor Junior team members in performing their various duties

• Review system and subsystem requirements, ensuring testability
• Contribute to FDA 510(k) submission development or other regulatory filings as assigned

• 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
• Ensure compliance with FDA device regulatory requirements
• Train individuals involved in verification and validation activities as needed.

• Create and maintain product risk management files and facilitate risk-based conversations with other functional engineering groups.
• Lead the execution of Design Control Phase reviews.

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, advanced degree desirable.
• Experience with using basic electronic test equipment including oscilloscopes, arbitrary waveform generators, multimeters, spectrum analyzers, power supplies, etc.
• Knowledge of testing and documentation of medical products
• Ability to handle multiple tasks while ensuring timely and accurate completion
• Demonstrated discipline and professionalism to work within published FDA device regulatory guidelines and rigorously follow internal Standard Operating Procedures, including documentation of the testing procedures and results
• Knowledge of FDA/cGMPs and global regulatory for Medical Devices
• 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

Undergraduate degree in an engineering discipline, graduate degree preferred. Experience of 6 years of system engineering in the medical device industry. Experience or working knowledge of testing medical devices, FDA/GMP requirements, knowledge of EMC & Compliance testing, software development life cycle, design control processes, and cross-functional product development team experience. Prior successful testing and validation of electronic/software medical products through full lifecycle strongly preferred.

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. $132,500 to $164,105 Full-Time Annual Salary