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.
Pay range $130,000-$175,000 per year plus bonus and equity. The range provided is based on what we believe is a reasonable estimate for the base pay range for this job at the time of posting. The actual base salary pay will be based on a number of factors such as education, qualifications, certifications, experience, and other job-related factors permitted by law.
Qualifications
- 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
