Manager, Sterilization & Biocompatibility

This position serves as the technical leader in Sterilization and Biocompatibility. Provides innovation for new sterilization technologies implements efficiencies and upgrades systems based on new standards.

• Provides technical leadership on microbiology sterilization and biocompatibility for the different LeMaitre manufacturing facilities.
• Manages Quality Engineers and support their day-to-day activities projects and validations.
• Collaborates with Manufacturing and R&D project teams to assess the impact of the process or product change.
• Supports internal and external audits as an SME in microbiology sterilization and biocompatibility.
• Creates quality plans for the impact assessment of changes applicable standards ex. ISO13408 ISO14160 ISO11135 ISO11137 ISO10993 ISO22442.
• Provides planning support for cleanroom and building expansions including aseptic processing.
• Updates procedures with the introduction of new products or facilities.
• Develop goals for the team that foster innovation and efficiency in the department.
• Maintains a working knowledge of government and industry regulation and standards.
• 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 $130000-$175000 per year plus bonus and equity. 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 in microbiology or biology required.
• 5 years related experience in ISO regulated industry.
• 2 years People management experience.
• Medical Device experience preferred.
• Knowledge of cGMPs.
• 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.

Applicants with disabilities may contact LeMaitre HR coordinators via telephone fax e-mail and other means to request and arrange for accommodations. If you need assistance to accommodate a disability you may request an accommodation at any time. Please contact LeMaitre HR at