Sr. Systems Engineer
Alphatec Spine
- Carlsbad, CA
- $125,000-140,000 per year
- Permanent
- Full-time
- Drive Navigation and Robotics integration
- Oversee the generation of protocols and reports for testing and design control documentation for the Design History Files (DHF)
- Ensure compliance with FDA device regulatory requirements.
- Perform resource planning and budgeting to support proposed technology projects.
- Identify strategically useful technologies, propose, and carry out proof of concept for implementation, and lead implementation efforts.
- As needed, work directly with IP team to survey patent landscape relative to specific areas of development, identify relevant innovations, prepare patent disclosures, and support the pursuit of IP protection.
- Attend surgical cases, engage with surgeons, and maintain familiarity with current company endeavors across technical areas.
- Proactively report on status of development, quality, and risks to management
- Effectively estimate time and effort on projects and tasks in collaboration with the team, demonstrate ownership and responsibility for assigned tasks.
- Assist/mentor Junior team members in performing their various duties
- Minimum 3 years of medical device engineering leadership experience
- Must be skilled at manage a significant workload and obtaining positive results, taking on additional responsibility and managing priorities as needed
- Strong verbal and written communication skills with the ability to produce accurate, punctual reports/information, as required and thoroughly share information with others. Must be able to read, write, and speak effectively
- Exceptional listening skills with the ability to seek constructive feedback, build relationships, promote teamwork, and remain flexible and open-minded. Able to quickly adapt to change
- Capable of creating and following realistic plans, goal setting, resource management, contingency planning, coordinating and cooperating with others
- Experience guiding teams through planning, prioritization and execution of work
- Experienced at delivering robust and reliable mission critical embedded medical systems
- Experience working positively and productively in a team environment. Highly collaborative
- Strong interpersonal skills with an ability to manage up and down within the organization
- Excellent time management, communication (written and verbal), decision-making, presentation, and organization skills
- Demonstrated success working with medical systems consistent with IEC 62304, and working within an ISO13485 regulated quality system environment
- Adept at creating and following realistic plans, goal setting, resource management, contingency planning, coordinating and cooperating with others
- Minimum 4 year/Bachelors Degree in Systems, Computer, Electrical/Electronics Engineering, Biomedical, or Mechanical Engineering or related discipline
- 3-10 years engineering leadership experience preferred in a Systems Engineering role
- 5-10 years experience in the field of medical device development, or the equivalent combination of education, training, and experience