Manager, Product Life Cycle Engineering
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Job Location:
Burlington, CO - USA
Monthly Salary:
Not Disclosed
Posted on:
22 hours ago
Vacancies:
1 Vacancy
Job Summary
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.
Qualifications
- Minimum Bachelors 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
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
Required Experience:
Manager
Key Skills
- Time Management
- Data Analytics
- Analytical
- Agile
- Requirement Gathering
- Strategic thinking
- Visio
- Communication
- Problem Solving
- Market Research
- UML
- Cross Functional Teams
About Company
LeMaitre Vascular makes the veins run on time. The company makes both disposable and implanted surgical vascular devices, including catheters and stents, under such brands as AnastoClip, EndoFit, and Pruitt-Inahara. LeMaitre was founded in 1983 by vascular surgeon George D. LeMaitre, ... View more
