LeMaitre · 1 week ago
Manager, Product Life Cycle Engineering
US-MA-Burlington
Full-time
Onsite
Mid, Senior Level
4+ years expLeMaitre is a company focused on medical devices, and they are seeking a Manager of Product Life Cycle Engineering. The role involves hands-on engineering responsibilities, management of product life cycle engineers, and ensuring compliance with industry standards for medical devices.
HardwareHealth CareManufacturing
Responsibilities
Serve as a 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
Have management responsibilities over Product Life Cycle Engineers (Currently 2 direct reports)
Have hands on development or revision responsibility 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
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
Qualification
Required
Minimum Bachelor's Degree in a technical field – Preferably with a Biomedical Engineering focus
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 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
Required to work onsite at the Burlington, MA office site
Up to 10% domestic & international travel
Company
LeMaitre
LeMaitre is a provider of devices, implants and services for the treatment of peripheral vascular disease, a condition that affects more than 200 million people worldwide.
501-1000 employees
H1B Sponsorship
LeMaitre has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)
2023 (3)
2022 (1)
2021 (2)
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
$204.5M2024-12-16Post Ipo Debt· $150M
2021-07-14Post Ipo Equity· $54.5M
2006-10-19IPO
Leadership Team
JJ Pellegrino
Chief Financial Officer and Board Member
Sandi Catino
Human Resources Business Partner
Recent News
2025-11-08
LeMaitre Vascular, Inc.
2025-11-07
2025-11-05
Company data provided by crunchbase