Manager, Product Life Cycle Engineering

LeMaitre Vascular•Burlington, MA

8d•Onsite

About The Position

Overview 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. Responsibilities 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.

Requirements

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

Responsibilities

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.