Sr. Engineer, Post Market Surveillance

Oversees and leads activities associated with complaint handling and regulatory reporting submissions. Responsible for the oversight management and direct support of investigational tasks required for complaint processing through to closure. Partner with Engineering Manufacturing Marketing Sales Customer Support and other functional experts as needed to ensure a clear understanding and an investigation of applicable issues.

• Processes complaints and regulatory (MDR Vigilance other) reports to ensure that complaints are documented reviewed evaluated investigated and formally closed in a timely manner.
• Interfaces directly with internal and external customers and regulatory agencies as required.
• Prepares and contributes responses to regulatory inquiries as needed.
• Supports quality metrics development and monitoring participating in regular business and quality system performance reviews.
• Reviews complaint data and prepares reports for internal customers as needed.
• Provides support for other Quality functions as needed including field actions corrective actions and others.
• Adheres to company policies procedures and documentation requirements.
• Treats others with courtesy sensitivity and respect at all times.
• Other duties as assigned.

Management Responsibilities:

• Sets goals and provides clear direction.
• Provides training coaching feedback and recognition.
• Responds to employees needs and questions as needed.
• Supports employees career goals and development.
• Communicates updates to your employees in a timely manner.
• Addresses employee concerns immediately.
• Addresses performance and behavior issues appropriately.

Pay range 00 per year plus bonus. The range provided is based on what we believe is a reasonable estimate for the base pay range for this job at the time of posting. The actual base salary pay will be based on a number of factors such as education qualifications certifications experience and other job-related factors permitted by law.

Bachelors degree required. Degree in Engineering Microbiology Biology Biomedical Engineering or equivalent field required preferred

2 years experience in Medical Devices or related industry. 3 years experience managing complaints. 1 year experience independent post market regulatory reporting experience (MDR and/or Vigilance) drafting and submissions.

Competency in at least two of the following areas; CAPAs NCMRs Validations Audit Design Control Complaints or Product Testing.

Microsoft Office.

In order to provide equal employment and advancement opportunities to all individuals employment decisions at LeMaitre Vascular will be based on merit qualifications and abilities. LeMaitre Vascular does not discriminate in employment opportunities or practices on the basis of race color religion sex national origin age disability sexual orientation gender identity breastfeeding or related medical conditions religious dress military or veteran status or any other characteristic protected by law.

This policy governs all aspects of employment including selection job assignment compensation discipline termination and access to benefits and training.