Staff Engineer, NPD - Gsc/At

Edwards Lifesciences Corp Irvine , CA 92606

Posted 2 months ago

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.

Responsibilities:

  • 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

Qualifications:

  • Bachelor's degree in Engineering with 6 years of manufacturing engineering experience.

  • Medical device experience.

Preferred Qualifications:

  • 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.


icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Staff Manufacturing Engineer GSC At/Tmtt

Edwards Lifesciences Corp

Posted 2 months ago

VIEW JOBS 4/3/2020 12:00:00 AM 2020-07-02T00:00 This is an exciting opportunity to join the Global Supply Chain (GSC) - Irvine Advanced Technology/Transcatheter Mitral Tricuspid Therapies (TMTT) operation integration organization leading the technical integration for TMTT implantable products. The Staff Manufacturing Engineer (Technical Integrator) will served as a main interface between R&D, Pilot and commercial manufacturing, contribute to commercialization of new product in the TMTT business unit, and the development of new or optimized manufacturing processes for TMTT in Heart Valve Center operations. Key Responsibilities: * Serve as the technical integrator supporting the design transfer of TMTT products to Pilot Operations, as well as commercialization activities, by ensuring R&D processes are characterized and scaled up by utilizing new technology and standard work. * Lead in the identification and ensure implementation of opportunities to optimize/improve manufacturing processes including using engineering methods (e.g., SIX Sigma and LEAN methods) employing technical design skills to re-design/design of and ensure equipment, tools, fixtures, etc. are up to standards. * Drive the development and manage the execution of complex experiments and tests (including writing and executing protocols) on a simple product line to qualify and validate manufacturing processes; analyze results, make recommendations, and develop reports. * Train, coach, and guide lower level employees on more complex procedures. Oversee manufacturing support tasks; give instruction to engineers/ technicians on conducting tests; train engineers/ technicians and provide feedback; and coordinate engineer/ technician work. * Lead and establish complex project plans to ensure deliverables are completed to customer's expectations, using project management tools (e.g., Project Plan, Risk Analysis, etc.). Analyze and resolve complex Manufacturing and Compliance issues (e.g., CAPA, non-conformances, audit observations). * Develop training and documentation materials (e.g., work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processes. * Perform other duties and responsibilities assigned. Qualifications: * Bachelor's Degree in in Engineering or Scientific field with 6 years of engineering manufacturing. Preferred Qualifications: * Master's degree in Engineering preferred. * Medical device manufacturing experience in heart valves, stents, catheters, delivery systems and/or interventional access devices is preferred. * Understanding of statistical techniques is required. Lean Six Sigma certification is preferred. * Extensive knowledge and understanding of principles, theories, and concepts relevant to Engineering as well as the production development process (PDP). * Advanced problem-solving, organizational, analytical and critical thinking skills. * Effective communication and project management skills are required. * Strong analytical, problem solving, and technical writing skills. * Ability to work well independently based on minimal guidance. * Strong interpersonal and intercultural skills are required. * Ability to work across various time zones and to travel both domestically up to 15%. Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. Edwards Lifesciences Corp Irvine CA

Staff Engineer, NPD - Gsc/At

Edwards Lifesciences Corp