Principal Project Engineer, Injection Molding

Job Description Summary:

The Principal Project Engineer, Injection Molding is a technical role 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 expertise in the management of projects for Molding Organization.

You will make an impact by:

• Overseeing 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.
• 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:

• A Bachelor's degree in engineering.
• Minimum of 6 years of experience in providing technical engineering support in a regulated industry.
• Strong proven leadership and successful project management skills. Ability to manage competing priorities in a fast-paced environment and communicate health of projects effectively
• Demonstrated track record in executing large scale projects.
• On-site required

What else we look for:

• Master’s Degree plus a minimum of 5 years of experience in providing technical engineering support in a regulated industry is preferred.
• Project Management Professional certification is preferred.
• 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 including high discretion/judgment in decision making
• 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.  Ability to translate complex and technical information to all levels of the organization.
• Innovative and strong execution skills with a demonstrated ability to deliver on short- and long-term strategic goals.
• Proven expertise in IT platforms, preferably Microsoft Office Suite and manufacturing systems (PLM, Ignite), and CAD experience.
• Ability to travel approximately 20%: domestic and international.

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

COVID Vaccination Requirement

Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you