- 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
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Sr. Systems Engineer - Carlsbad, United States - Alphatec Spine
Description
Job Description
Job DescriptionThe Senior Engineer will lead Systems Engineering integration efforts related to surgical Navigation and Robotics integration. These may also include software/firmware/hardware/systems solutions aimed at other technical areas as needed. The role includes collaborating with cross-functional R&D teams in the implementation of designs in electronic hardware, firmware, and software from concept through production release located in both Louisville, Colorado and Carlsbad, California.
Essential Duties and Responsibilities
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.
Education and Experience
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. $125,000 to $140,000 Full-Time Annual Salary
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