Lifecycle Engineering Manager - Medical Devices

LeMaitre; Burlington (MA); On-site; USD 130,000 - 175,000; Full time

Job summary

LeMaitre Vascular is seeking a hands-on Engineer to develop or revise testing protocols and reports ensuring regulatory compliance for Class I–III medical devices. You will lead lifecycle engineering and align with manufacturing teams to translate design requirements into validated processes.

Ideal candidates have a technical Bachelor's degree and 4+ years of product development experience, with strong problem-solving, communication, and cross-functional collaboration skills.

Qualifications

• Bachelor's degree in a technical field (Biomedical Engineering preferred).
• Minimum 4 years of relevant work experience.
• Minimum 3 years product development experience leading technically sophisticated medical devices.
• Working knowledge of ISO13485; ISO14971 and FDA GMP/QSR.
• On-site work in Burlington, MA; up to 10% travel.

Responsibilities

• Have management responsibilities over Product Life Cycle Engineers (2 direct reports).
• Develop or revise testing protocols and reports for regulatory compliance.
• Collaborate with Regulatory Affairs and Quality to ensure standards are current.
• Conduct gap assessments on product documentation and make improvements.
• Initiate change orders and guide cross-functional groups.
• Participate in CAPA related to product conformance.
• Partner with multifunctional leaders to ensure alignment and execution.
• Ensure voice of the customer informs design decisions and validation in manufacturing.
• Ensure projects comply with GMP, ISO, MDD/MDR and LeMaitre policies.
• Capture and disseminate knowledge to improve development processes.
• Acquire resources from functions and outside sources to ensure project success.

Skills

Problem solving

Communication

Teamwork

Influencing skills

Self-directed work

Education

Bachelor's degree in a technical field

Job description

LeMaitre Vascular is seeking a hands-on Engineer to develop or revise testing protocols and reports ensuring regulatory compliance for Class I–III medical devices. You will lead lifecycle engineering and align with manufacturing teams to translate design requirements into validated processes.

Ideal candidates have a technical Bachelor's degree and 4+ years of product development experience, with strong problem-solving, communication, and cross-functional collaboration skills.