Job Description:

Innovation starts from the heart. Edwards Lifesciences i is the leading global structural heart innovation company, driven by a passion to improve patient lives. With millions of patients served in over 100 countries, each team makes a meaningful contribution by improving patient outcomes and discovering lasting solutions for unmet patient needs. Our Principal Project Engineer, Injection Molding position is a unique career opportunity that could be your next step towards an exciting future.

The Senior Project Engineer, Injection Molding role is focused on supplier performance supporting all manufacturing sites by ensuring that injection molded parts used in commercial environment are robust, harmonized & scalable utilizing best technologies, process capable, validated per design control and compliant with Regulatory requirements. Project management is a key function of this role and includes formal project planning and tracking. In addition, this role is part of a cross-functional team that is responsible for supporting sourcing strategies including supplier recommendation, evaluation, and development.

Provides management of projects for the Molding Organization.

You’ll make an impact by:

• Oversee the technical performance of suppliers in the manufacturing of injection molded components including new, repaired and/or transferred molds.  Adhere to the Molding Playbook to drive tooling fabrication, process optimization using scientific injection molding principles, validation, and production release.  Includes process improvement opportunities and innovation on commercial products.

• Management of multiple projects from feasibility through implementation including charter & scope, detailed plan, defined schedule, risks mitigation, progress reports and cost management.  Escalate project risks to management, as required.  In addition, plans, organizes, and conducts all aspects of technical reviews with SME support.

• Contributor to Design for Manufacturability (DFM) input during product development phases including plastic part design and mold design & construction.

• Support thermoplastic and silicone tooling and processing troubleshooting, and drive problem solving with suppliers.

• Supports IQ/OQ/PQ validation efforts within Edwards and at suppliers.  Ensure proper documentation is completed to meet quality system requirements. (e.g., Design Reviews, Component Dwgs, FMEA’s, Mfg Procedures, BOM’s, Routers, etc.).

• Participate cross-functionally (Engineering, Quality, Validations, Regulatory Affairs, and Operations) and across manufacturing sites to support strategies including capacity, supplier sourcing, logistics, equipment and processes to meet key business goals.

• Perform other duties and responsibilities as assigned.

What you’ll need (Required):

• A Bachelor's degree in engineering or Scientific field plus 4 years of experience in providing technical engineering support in a regulated industry.

• On-site

What else we look for (Preferred):

• Master’s Degree plus a minimum of 3 years of experience in providing technical engineering support in a regulated industry.

• Successful project management skills. Ability to manage competing priorities in a fast-paced environment and communicate health of projects effectively

• Technical knowledge and hands-on experience in manufacturing with general understanding of plastics engineering, injection mold design & construction and injection mold processing.

• Supplier relationship building, development, and project support.

• Problem-solving, analytical, and critical thinking skills

• Knowledge of technical operations, preferably including medical device, process excellence methodologies such as Six Sigma, and FDA regulations, cGMP, ISO standards and EH&S guidelines.

• Excellent documentation, communication, and interpersonal skills. 

• Proven expertise in IT platforms, preferably Microsoft Office Suite and manufacturing systems (PLM, Ignite), and CAD experience.

• Ability to travel approximately 10%: domestic and international.

Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.

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.