Edwards Lifesciences
Principal Project Engineer, Injection Molding
Edwards Lifesciences, Irvine, California, United States, 92713
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 Principal 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 expertise in the management of projects for 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.
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.
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 (Preferred):
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 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, the base pay range for this position is $115,000 to $163,000 (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.
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
COVID Vaccination Requirement
Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.
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 Principal 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 expertise in the management of projects for 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.
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.
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 (Preferred):
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 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, the base pay range for this position is $115,000 to $163,000 (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.
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
COVID Vaccination Requirement
Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.