This is a unique opportunity to join the Advanced Technologies (AT) business unit as an NPD Engineer. This position will allow someone to get in on the earlier stage of new product introduction developing and implementing new manufacturing processes and technology resulting in high capacity and a sustainable product line. This role will interact with cross-functional internal and external engineering resources to implement advanced processes and have a meaningful and direct impact on new device introduction.
Provide new product development support in the design and development of implantable devices and delivery systems used to treat cardiovascular disease. Conduct engineering activities from early product development through product launch.
Assess and develop supplier capability. Work directly with suppliers to address specification and quality issues. Conduct non-conformance and MRB activities to support initial builds.
Develop and execute operations strategy to integrate new products into manufacturing. Manage product phase in/phase out activities around design, regulatory and clinical requirements. Conduct manufacturing readiness reviews and complete design transfers to manufacturing.
Utilize Six Sigma methodologies to identify potential manufacturing opportunities.
Evaluate manufacturing processes that could be improved and developed a strategy for implementation.
Provide leadership in the area of continuous improvement to significantly impact Cost Standards, Operations/Business System Efficiency and elimination of non-value added work.
Draft, approve, execute, and maintain relevant documentation such as SOPs, specifications, drawings, process sheets, FMEAs, and facilitate validation protocols as necessary to support implementation of equipment projects, as well as new process integrations.
Collaborate with team leadership in identifying risks and develop contingency plans (i.e. schedule slippage). Ensure that risk mitigation plans are implemented to achieve project timelines.
Facilitate team decision-making, identify and escalate issues when appropriate.
Apply DFM concepts, tools and analysis. Conduct reviews to ensure DFM considerations are incorporated into designs.
Execute Operations Integration Plans
Bachelor's degree in Engineering with 6 years of manufacturing engineering experience.
Medical device experience.
An advanced degree is preferred.
Medical device manufacturing experience in heart valves, stents, catheters, delivery systems and/or interventional access devices is preferred.
Experience using ProE or SoliWorks is preferred.
Understanding of statistical techniques.
Experience in leading scale-up and manufacturing implementation projects within an FDA regulated, manufacturing environment is required.
Demonstrated use of process excellence methodologies, such as six sigma methodologies.
Demonstrated use of Design for Manufacturability, Industrial Engineering and LEAN experience leading to manufacturing efficiency improvement.
Knowledge of cGMP, EHS guidelines, FDA guidelines, Supplier Quality and Process Validation.
Effective negotiation skills and ability to work through obstacles effectively.
Capable of analyzing and solving complex problems in a fast pace environment through innovative thought and experience.
Ability to develop process requirement specifications, collaborate with outside design firms and work with Operations personnel to establish efficient solution systems.
Strong communication and interpersonal skills.
Strong analytical, problem solving and technical writing skills.
Ability to work well independently as well as part of a team.
20% travel domestic and international.
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Edwards Lifesciences Corp