Lead Systems Engineer

JOB SUMMARY
The Lead Systems Engineer will help lead the design and development effort. The Engineer will participate directly in the system design and technology development efforts. Will be solving a broad array of complex problems that bring together multiple engineering disciplines to create original and innovative solutions. Will interface with internal engineering staff, field operations, quality assurance, regulatory affairs, product management, external consultants, as well as external suppliers/contract manufacturers. This position is based in the Fremont, CA office.
DUTIES & RESPONSIBILITIES

• Support manufacturing and field operations with existing products.
• Work with Manufacturing to coordinate design transfer and release of new products.
• Lead product complaints investigation and closure.
• Initiate and support corrective action per CAPA procedure to prevent product non-conformances.
• Work within quality system environment to produce required technical and regulatory documentation.
• Manage design and development projects according to company Design Control procedures and in compliance with the ISO 13485.
• Participate in and/or lead safety risk management activities in compliance with the ISO 14971.
• Develop and execute test methods to evaluate proposed design changes.
• Develop and procure test fixtures for design change evaluations and to support manufacturing.
• Participate in product development activities through the full product life cycle, including feasibility and prototyping, requirements generation, design and development, and technical review.
• Interface with vendors, contractors, and clinicians to develop and realize design requirements.
• Produce and execute development plans in accordance with department goals and objectives.
• Author system level requirements that identify various subsystems and requirements for these subsystems.
• Participate in and/or lead system level verification and design validation.

• Contribute to the process improvement and best practice implementation.

• Drive design assurance activities for multiple projects according to established procedures.
• Identify and mitigate technical risk areas through coordination with cross-functional team.
• Understand complex technical topics and issues and communicates such knowledge effectively.
• Interface with other functional departments including quality assurance, regulatory affairs, and manufacturing, to ensure effective collaboration and teamwork.

SUPERVISORY RESPONSIBILITIES

• N/A

QUALIFICATIONS
Required:

• Bachelor's degree in engineering or science with 8+ years of experience in developing complex systems and/or medical devices.
• Experienced in leading cross-functional teams using a structured approach to solving complex technical problems.
• Experienced with all phases of the product development life cycle including product concept development, design, implementation, debug, verification, validation of customer needs/design requirements, design transfer, and maintenance.
• Knowledge of GD&T, the principles of Design for Manufacturing (DFM).
• Excellent communication and documentation skills.
• Industry experience in medical device development following FDA design controls, thorough knowledge of FDA Quality System Regulation, ISO 13485 (Quality System) requirements, ISO 14971 (Risk Management) requirements, and IEC 62366 Medical Devices - Application of Usability.
• Familiarity or experience with regulatory environments, industry-based standards, including testing for safety and EMC according to 60601-1, and 510(k) submissions.
• Knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards.

Preferred:

• Master's degree in computer science, mechanical, electrical engineering, or related field.
• Project Management experience.
• Experience in system design involving robotic technology components.
• Electro-mechanical handheld device experience.
• Experience with SolidWorks, Altium, OrCAD or similar tools.

COMPETENCIES

• Drives results
• Optimizes work processes
• High quality work and documentation
• Manages complexity
• Business insight
• Situational adaptability
• Persuades
• Collaborative

PHYSICAL DEMANDS & WORK ENVIRONMENT

• Must be able to remain in a stationary position and operate office equipment for a prolonged period of time.
• Physical activities include, but not limited to constant manual dexterity, moving about the work site, and/or handling objects weighing up to 20 lbs.
• Other infrequent physical activities include, but not limited to, positioning self to complete assigned tasks, and ascending/descending floors and/or ladders.
• Occasionally work around moving mechanical parts.
• Must be able to work in a schedule that commensurate with business operation, including work during weekends, holidays and/or times outside of normal business hours.
• Must be able to travel as business necessitates (up to 25%).

Disclaimer:
The above is intended to describe the general content of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities, or physical requirements. Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Reasonable accommodations may be possible to enable individuals with disabilities to perform the essential functions.
THINK Surgical, Inc. ("THINK") is committed to hiring the best qualified candidates for approved positions while engaging in recruitment and selection practices that are in compliance with all applicable employment laws. It is the policy of THINK to provide equal employment opportunity for employment to all applicants and employees, regardless of any protected status. Any qualified applicant or employee with a disability who requires an accommodation in connection with their employment at THINK should contact Human Resources and request an accommodation. THINK also participates in E-Verify, a web-based system that allows THINK to confirm an employee's eligibility to work in the United States. Actual compensation offered will depend on several factors including but not limited to geographic location, work experience, education, skill level, and/or other business and organizational needs.