Overview

Serve as the hands on Engineer responsible for development or revision of testing protocols and reports aimed at continued regulatory compliance with existing and revised industry standards related to Class I, II and III medical devices.

Responsibilities

• Continuously engage with Regulatory affairs and Quality affairs teams to ensure that all standards are current and fully applied to our products.
• Conduct Gap assessments on product technical documentation and make recommendations for improvement.
• Initiate change orders for implementation of changes or guide cross-functional groups to do the same.
• Participate in CAPA process as it relates to product conformance
• Develop strong partnerships with multi-functional leaders to ensure that alignment, efficiency, and execution meet business requirements
• Ensure that the voice of the customer is present in all decisions and that all design requirements are translated into practical design changes that can be verified and ultimately validated in manufacturing
• Ensure projects are carried out in compliance with regulatory requirements (GMP, ISO, MDD/MDR) & LeMaitre policy & procedure requirements
• Capture & disseminate knowledge acquired during projects to improve LeMaitre product development processes & systems
• Acquire resources from functional organizations, support groups & outside sources to ensure project success
• Provide assistance in related areas when needs arise.

Qualifications

• Minimum Bachelor's Degree in a technical field
• Minimum (4) years of relevant work experience
• Minimum (3) years product development experience with a proven track record of accomplishment: direct association with or leading efforts to develop technically sophisticated products from concept to market
• Strong problem-solving and execution skills for developing creative solutions and meeting project objectives
• Ability to balance schedule, cost & quality
• Detailed knowledge of new product development processes and/or change management methodologies in a medical device or IVD setting.
• Excellent communication, teamwork and influencing skills
• Consistent track record to deliver project outcomes in an ambiguous environment
• Experience leading self-directed work teams
• Working knowledge of ISO13485; ISO14971 and FDA GMP/QSR
• Ability to work at the Burlington, MA office site.
• Up to 10% domestic & international travel – (conditioned up Covid restrictions and company policies)

EEO Statement

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 HR@lemaitre.com.