Senior Engineer, New Product Introduction

Edwards Lifesciences; Irvine (CA); On-site; USD 106,000 - 149,000; Full time

Job summary

A leading company in the medical device industry seeks a Supply Chain Engineer to support New Product Introduction activities and ensure seamless manufacturing processes. You will collaborate cross-functionally, driving improvements and ensuring operational readiness for life-saving products. This role demands a blend of engineering expertise and strong communication skills, with a focus on enhancing manufacturing efficiencies and product quality.

Qualifications

• 4 years of medical device manufacturing experience.
• Proven track record in design transfers to Operations.

Responsibilities

• Supports New Product Introduction for implantable devices.
• Acts as a liaison between R&D and manufacturing.
• Drives critical integration meetings for development activities.

Skills

Communication

Problem Solving

Analytical Thinking

Education

Bachelor’s degree in engineering or scientific

Tools

Six Sigma

LEAN

Job description

Imagine how your ideas and expertise can change a patient’s life. Our Global Supply Chain team plays a central part in ensuring our products are delivered to patients with cardiovascular disease. You’ll partner cross-functionally with manufacturing operations and sales teams, delivering thoughtful solutions to complex challenges all while developing your knowledge of the medical device industry. Whether your work includes strategic inventory planning, labeling, warehouse management, material handling, or any of our other supply chain opportunities, you will be making a meaningful contribution to our team and to patients all over the world.

Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient’s unmet clinical needs. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

How you will make an impact:

• Provides support for New Product Introduction (NPI) activities for class III, implantable devices for Edwards' comprehensive portfolio of transcatheter heart valve replacement therapy.

• Advances the objectives of the Global Supply Chain (GSC) Network by supporting supply chain development and associated engineering activities from early product development through product launch.

• Ensures manufacturing processes are developed that meets operational needs for capacity and scale while ensuring cross functional alignment across manufacturing sites in different locations including readiness at suppliers

• Acts as a liaison between R&D, supplier development, quality and sustaining operations to ensure readiness to seamlessly plan, source, make and deliver the product to customers around the world.

• Supports operational transitions through development, clinical, and commercialization including completion of design transfer deliverables to ensure end-to-end readiness.

• Partners cross functionally with pilot, sustaining operations and, domestic and international manufacturing locations to harmonize transfer plans and validation strategies across all sites.

• Drives and leads critical integration meetings to inform stakeholders across GSC and related functions on progress and risks. Ensure risks are clearly identified and addressed for smooth execution of development activities

• Identifies manufacturing and scale-up risks at pilot and production sites, and develop, implement appropriate mitigation plans, including business continuity plans at suppliers.

• Identifies and drives continuous improvements in manufacturing processes including opportunities to incorporate digital strategy, automation initiatives, mistake proofing while elevating quality standards.

• Ensures accuracy of part/drawings, bill of materials (BOM) and other manufacturing documentation. Leads the execution of playbooks to ensure successful assessment and deployment of sourcing, planning, transfer and supplier assessment by PDP phases.

• Collaborates with cross functional partners to ensure Design for Manufacturability (DFM), Six Sigma, and LEAN considerations are incorporated into product and process designs, including design and process 3P across sites.

• Provides analysis and tracks progress against agreed upon targets and deliverables to attain operational metrics required for successful commercialization of products.

What you’ll need:

• Bachelor’s degree engineering or scientific with four years of medical device manufacturing experience.

• Proven track record in design transfers to Operations and process and equipment validation.

• On-site required.

• Travel 10% domestically or internationally.

What else we look for:

• Degrees in mechanical, manufacturing, or industrial engineering are highly preferred.

• Understand injection molding, polymers, medical textiles and commonly used materials in the medical device space, such as Nitinol and implantable, with working knowledge of metals processing.

• Experience in developing process requirement specifications, collaborating with external parties, suppliers and working with Operations personnel to establish efficient solution systems

• Expertise around manufacturing engineering: design for manufacturability, design and process excellence methodologies including Six Sigma, LEAN experience, cGMP, EH&S guidelines, supplier development engineering and process validation.

• Excellent communication and interpersonal skills at all levels of employees including upper management, suppliers, operators and external parties.

• Excellent problem-solving, organizational, analytical and critical thinking skills including high discretion/judgment in decision making.

For California (CA), the base pay range for this position is $106,000 to $149,000 (highly experienced).

The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).Applications will be accepted while this position is posted on our Careers website.