Complaints Engineer chez undefined

JOB SUMMARY

Join a dynamic and innovative team dedicated to revolutionizing the medical device industry. Our company specializes in the development and manufacturing of cutting-edge handheld surgical robots designed to enhance precision and patient outcomes. We are seeking a highly skilled Complaints Engineer to spearhead medical device customer complaint investigations and write-ups performed in accordance with applicable regulations and Quality System requirements. This position will ensure timely, accurate, and complete failure investigations, root cause analyses, risk analyses, CAPA activities, and other complaint-related tasks for product failures. This position is based the Fremont, CA office.

DUTIES & RESPONSIBILITIES

• Receive, manage and investigate customer product complaints. 
• Work within cross-functional internal and external teams to investigate product complaints and provide solutions to resolve complaints in a timely manner.
• Communicate effectively to ensure cross functional coordination on investigations and provide updates to management.
• Organize/lead cross-functional teams to analyze complaint trend data.
• Identify actionable insights and continuous improvement for product/process.
• Organize/lead cross-functional teams to implement effective corrective/preventive actions to prevent recurrence of the problem ensuring appropriate documentation of all activities. 
• Drive updates to applicable risk management documentation as needed.
• Develop, update, and maintain Procedures and Work Instructions to facilitate and standardize investigation activities.
• Investigate and resolve issues related to customer product complaints.
• Perform failure analysis of mechanical, electromechanical, and software aspects of the surgical robot using various types of test equipment, fixtures, and software tools. 
• Analyze data, identify patterns, and evaluate complex information to identify problem areas.
• Ensure timely, accurate, and complete failure investigations of product complaints leading to the root cause and corrective/preventive action (if applicable) and ensure that all activities are documented in the complaint management system.

• Ensure quality and regulatory compliance:
  • Coordinate cross functional teams to complete post market risk assessments and drive periodic updates to Risk Management Reports and potentially other documents. 
  • Ensure adherence to SOP’s, applicable regulatory standards and quality requirements.

SUPERVISORY RESPONSIBILITIES

• N/A

QUALIFICATIONS

 Required:

• Bachelor’s degree in engineering or science with 4+ years of experience in root cause analysis and/or developing complex systems and/or medical devices.
• Knowledge of mechanical, electromechanical, and software systems.
• Previous device investigation experience.

• Strong analytical skills with the ability to ensure accurate documentation.
• Excellent problem-solving skills with a proactive and hands-on approach to coordinating resolution activities.
• Time management skills to complete tasks in timely manner and manage changing and/or urgent priorities.
• Knowledge of and ability to effectively use analytical tools and methods including statistics, DOE, and the use of computer software packages related to testing, data collection, and calibration.
• Strong communication and leadership skills, with the ability to collaborate effectively across multidisciplinary teams.
• Knowledge of FDA regulations, Good Documentation Practices, ISO 13485 (Quality System) requirements, ISO 14971 (Risk Management) requirements.

• Knowledge of good manufacturing practices (GMP) and applicable Quality System Standards.

Preferred:

• Master’s degree in computer science, mechanical, electrical engineering, or related field.
• Experience with electronic quality management systems (eQMS) and complaint management software.
• Project Management experience.

COMPETENCIES

• Drive results
• Optimize work processes
• High quality work and documentation
• Possess a professional and positive outlook
• Situational adaptability
• Effective communication and collaboration 

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.