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Principal Project Engineer, Injection Molding

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 and 6 years of experience in providing technical engineering support in a regulated industry.
  • 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.
  • Project Management Professional certification.
  • 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 (CA), the base pay range for this position is $118,000 to $167,000 (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.

Average salary estimate

$142500 / YEARLY (est.)
min
max
$118000K
$167000K

If an employer mentions a salary or salary range on their job, we display it as an "Employer Estimate". If a job has no salary data, Rise displays an estimate if available.

What You Should Know About Principal Project Engineer, Injection Molding, Edwards

Welcome to the exciting world of Edwards Lifesciences, where innovation is at the heart of everything we do! We're currently on the lookout for a Principal Project Engineer, Injection Molding to join our vibrant team in Irvine, California. This role is not just a job; it’s a chance to be part of a mission that improves the lives of millions of patients worldwide. As a Principal Project Engineer specializing in injection molding, you’ll oversee the lifecycle of mold part performance—ensuring they’re robust, harmonized, and compliant with all regulatory requirements. Your knack for project management will shine as you navigate through various projects from concept to execution, managing timelines, risks, and results. You’ll collaborate with cross-functional teams to enhance our sourcing strategies, tackle challenges, and provide critical insights into design and manufacturability. Strong problem-solving and analytical skills will be essential as you work closely with suppliers to drive improvements and maintain our standards of excellence. To excel in this role, you’ll need at least a Bachelor’s degree in engineering and substantial experience in a regulated industry—because here, precision and compliance matter! If you're ready to take that next big step in your career and make a genuine impact, we’d love to hear from you. Edwards Lifesciences offers competitive salaries, comprehensive benefits, and a commitment to your professional growth. Join us in making a difference today!

Frequently Asked Questions (FAQs) for Principal Project Engineer, Injection Molding Role at Edwards
What are the key responsibilities of a Principal Project Engineer, Injection Molding at Edwards Lifesciences?

The Principal Project Engineer, Injection Molding at Edwards Lifesciences plays a pivotal role in overseeing the technical performance of suppliers involved in manufacturing injection molded components. This includes managing multiple projects from feasibility through implementation, participating in Design for Manufacturability (DFM) discussions, and ensuring compliance with quality system requirements. Additionally, the role involves driving process optimization and collaborating cross-functionally to support sourcing strategies across manufacturing sites.

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What qualifications are needed for the Principal Project Engineer, Injection Molding position at Edwards Lifesciences?

To qualify for the Principal Project Engineer, Injection Molding at Edwards Lifesciences, candidates should possess at least a Bachelor's degree in engineering coupled with 6 years of relevant experience in a regulated industry. Preferred candidates may hold a Master's degree and Project Management Professional certification, alongside strong analytical skills, technical knowledge of plastics engineering, and effective communication abilities.

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How does project management play a role in the Principal Project Engineer, Injection Molding role at Edwards Lifesciences?

Project management is essential for the Principal Project Engineer, Injection Molding at Edwards Lifesciences. This role involves formal project planning, tracking progress, managing timelines, and coordinating resources to ensure all projects are completed successfully. The engineer will escalate project risks as necessary and be responsible for delivering timely, detailed reports to management while ensuring that all project aspects meet strict regulatory and compliance standards.

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What types of projects will the Principal Project Engineer, Injection Molding manage at Edwards Lifesciences?

The Principal Project Engineer, Injection Molding will manage a diverse array of projects, including new mold introductions, mold repairs, and transfers. The projects encompass detailed planning for tooling fabrication, process optimization, and validation stages, ensuring that every injection molded component produced adheres to the high quality and performance standards expected at Edwards Lifesciences.

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What is the culture like for the Principal Project Engineer, Injection Molding at Edwards Lifesciences?

The culture for the Principal Project Engineer, Injection Molding at Edwards Lifesciences is built around innovation, collaboration, and a strong commitment to patient outcomes. Employees are encouraged to express their creativity and expertise while working in cross-functional teams. The company fosters a supportive environment where continuous learning and professional growth are promoted, making it a great place for engineers looking to advance their careers in the medical device industry.

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Common Interview Questions for Principal Project Engineer, Injection Molding
Can you describe your experience with injection molding processes?

When preparing to answer this question, focus on your hands-on experience with injection molding processes. Discuss specific projects where you were involved, emphasizing your role in process optimization and any innovative solutions you implemented. Detail your knowledge of mold design and construction to highlight your technical proficiency.

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How do you approach project management in engineering projects?

In answering this question, explain your project management methodology, including how you plan, execute, and monitor projects. Describe your experience with risk mitigation and progress reporting while showcasing tools or frameworks you utilize to ensure projects are delivered on time and within budget.

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What strategies do you use for supplier management?

Discuss your approach to building relationships with suppliers and your experience evaluating and developing suppliers. Focus on communication strategies, monitoring performance metrics, and resolving conflicts to maintain a smooth production process.

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How familiar are you with regulatory requirements in the medical device industry?

The interviewer is looking for your understanding of FDA regulations, ISO standards, and cGMP practices. Discuss your experience ensuring compliance during product development and your familiarity with document control measures required in a regulated environment.

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Can you provide an example of a problem you solved in an engineering role?

Prepare a concrete example of a challenge you faced in a previous role related to injection molding or project management. Describe the steps you took to analyze the problem, the solutions you proposed, and the outcome of your actions, demonstrating your critical-thinking skills.

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What tools and technologies do you prefer to use in your engineering projects?

Discuss the IT platforms and software you are proficient in, such as CAD software, PLM systems, and project management tools. It’s important to also mention how these tools have enhanced your project outcomes or efficiency in previous roles.

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How do you participate in cross-functional teamwork?

Share specific examples of how you have worked in cross-functional teams, emphasizing your communication skills and your ability to collaborate effectively with colleagues from different departments like Quality, Regulatory Affairs, and Operations.

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What improvements have you implemented in past projects?

Highlight your contributions to past projects by discussing specific improvements you initiated. This could involve process enhancements, cost-saving measures, or efficiency boosts, showcasing your impact on project outcomes and team performance.

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How do you handle tight deadlines and high-pressure situations?

When discussing your experience with tight deadlines, emphasize your organizational skills and time management strategies. Share a relevant scenario that illustrates your ability to prioritize tasks and remain focused under pressure.

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What motivates you to work in the field of medical devices?

Reflect on your passion for engineering and the positive impact of medical devices on patient lives. Discuss how this passion drives your commitment to quality and innovation in your work, aligning with Edwards Lifesciences' mission.

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Reward & Recognition
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Growth & Learning
Transparent & Candid
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MATCH
VIEW MATCH
FUNDING
DEPARTMENTS
SENIORITY LEVEL REQUIREMENT
TEAM SIZE
No info
HQ LOCATION
No info
EMPLOYMENT TYPE
Full-time, on-site
DATE POSTED
April 19, 2025

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