Engineer, Product Life Cycle Management

Overview

The Product Lifecyle engineer will be responsible for sustaining LeMaitre product lines throughout the entire product lifecycle. You will work closely with R&D, Quality, Regulatory and Manufacturing teams to support regulatory submissions, maintain good market status, and engineer solutions that improve the safety, quality and efficacy of Class I, II and III medical devices.

Responsibilities

• Engage with cross-functional teams to ensure that all internal and external product requirements are current and fully applied to all products
• Conduct Gap assessments on product technical documentation and make recommendations for improvement, Initiating change orders for implementation of changes
• Identify, launch and coordinate design and process improvement projects to improve device safety, quality and efficacy.
• Contribute to CAPA process as it relates to product conformance to internationally recognized standards and regulations as well as internal requirements.
• Draft Protocols, Reports and execute product testing to address gaps in Design V&V
• Develop strong partnerships with multi-functional leaders to ensure that alignment, efficiency, and execution meet business requirements.
• Ensure the voice of the customer is present in all decisions and that all user needs are translated into practical design requirements that can be implemented, verified, validated
• Ensure projects are carried out in compliance with regulatory requirements (GMP, GDP, ISO, EU MDR) & LeMaitre policy & procedural requirements.
• Capture & disseminate knowledge acquired during projects to improve LeMaitre processes & systems.

Qualifications

• Minimum Bachelor's Degree in an Engineering Discipline or relevant technical field
• Minimum (3) years of relevant work experience with a proven track record of accomplishment and integrity. To direct association with or leading efforts to sustain products or develop products with continued support throughout the product lifecycle.
• Strong problem-solving and execution skills for developing creative solutions to solve complex problems and meet project objectives
• Working knowledge of design controls with experience developing devices by identifying user needs developing them into design input requirements, understanding the role and purpose of Verification and Validation testing
• 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.
• Knowledge of statistical techniques and applications
• Excellent communication, teamwork and influencing skills
• Consistent track record of delivering project outcomes in an ambiguous environment
• Working knowledge of EUMDR, ISO13485; ISO14971 and FDA GMP/QSR, GDP, CFR 820
• Ability to work onsite at the Burlington, MA office.
• Up to 10% domestic & international travel – (conditioned upon 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.