Sr. Quality Engineer, NPD - IHFM

Edwards Lifesciences Gruppe; Irvine (CA); On-site; USD 108,000 - 153,000; Full time

Job summary

Edwards Lifesciences Gruppe in Irvine, CA is seeking a senior engineer to provide technical leadership in New Product Development for implantable heart failure devices. You will apply design controls, drive risk management, verify and validate designs, and collaborate across functions to deliver robust products from concept through product launch.

Candidates should have a engineering degree with experience in medical devices, proficiency in statistics, project leadership, and the ability to

Qualifications

• Bachelor's or higher in engineering/science with required experience.
• Experience in Medical Device Design Controls, DV, and Process Validation.
• NPD experience from concept to commercialization (Class III preferred).
• Knowledge of regulatory requirements for medical devices (US/International).

Responsibilities

• Provide technical leadership for new product development from concept to launch.
• Lead risk management updates for new products.
• Lead test method development and validation for new designs.
• Oversee inspection/testing mechanisms for components and assemblies.
• Collaborate with manufacturing to transfer and launch robust products.
• Manage a team of direct reports and develop talent.
• Ensure compliance with applicable regulations and company policies.
• Travel up to 20% domestically and internationally.

Skills

Design Controls

Design Verification & Validation

Risk Management

Test Method Development

Statistical Techniques

Quality Engineering

Leadership

Cross-functional Collaboration

Project Management

Education

Bachelor's Degree in Engineering or Scientific field

Master's Degree or equivalent in Engineering or Scientific field

Ph.D. or equivalent in Engineering or Scientific field

Tools

MS Project

MS Office Suite

Job description

Many structural heart patients suffer from heart failure with limited options. Our Implantable Heart Failure Management (IHFM) team is at the forefront of addressing these unmet patient needs through pioneering technology that enables early, targeted therapeutic intervention. Our innovative solutions are not just transforming patient care but also creating a unique and exciting environment for our team members. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. We are looking for a strong engineer with solid technical expertise, who enjoys working in a fast-paced and rapidly growing environment where taking initiative and collaborating cross-functionally are critical for success. The engineer will have a variety of responsibilities in New Product Development providing Quality Engineering support and leadership to ensure the successful design and development of new products.How you will make an impact:• Provide technical leadership for successful new product development projects by applying design control and risk management principles to positively influence new product development efforts from concept through product launch including design verification, validation, and design and manufacturing specification development.• Partner and collaborate with cross-functional stakeholders and peers on new product development teams to align on goals and drive actions to meet commitments.• Lead development and drive updates to risk management files for new products• Lead test method development and validation activities for new designs• Lead development and implementation of inspection and testing mechanism for components, sub-assemblies, and final assemblies used in new product design and manufacturing• Develop technical solutions to complex problems, recommend and implement corrective actions, using creativity, statistical techniques, and reliability engineering• Collaborate with manufacturing and operations team to ensure successful transfer and launch of robust products.• Managing/overseeing the work of an assigned team of direct reports within own function.• Developing a robust talent development plan in alignment with functional growth strategies of the individual and the department.• Ensure compliance with all Federal, State, local and company regulations, policies and procedures.• Performs other incidental duties as assigned by management• Ability to travel up to 20% domestically and internationallyWhat you'll need (Required):• Bachelor's Degree in Engineering or Scientific field, 4 years’ experience including either industry or industry/education or• Master's Degree or equivalent in Engineering or Scientific field, 3 years’ experience including either industry or industry/education or• Ph.D. or equivalent in Engineering or Scientific field with industry experience or industry/educationWhat else we look for (Preferred):• Current or prior experience within Medical Device industry• Knowledge and experience within Design Assurance, including Design Controls, Design Verification & Validation, Test Method Development, and Process Validation• New Product Development experience from initial concept to commercialization (Class III preferred).• Experience with Risk Management and Design Control• Working knowledge of the Domestic and International regulatory requirements of Medical Device regulations• Proven expertise in usage of MS Office Suite including MS Project• Advanced understanding of statistical techniques• Strong problem-solving, organizational, analytical and critical thinking skills• Quality Engineering experience in New Product Development is preferred• Strong documentation, communication, and interpersonal relationship skills including negotiating and relationship management skills• Ability to prioritize, plan, and evaluate deliverables to established strategic goals• Ability to interact professionally with all organizational levels• Ability to manage competing priorities in a fast-paced environment• Must be able to work in a team environment, including inter-departmental teams and key stakeholders representing the organization on projects• ASQ Certified Quality Engineer (CQE), Quality System Lead Auditor, Certified Six Sigma Black Belt (CSSBB), or related quality/regulatory certifications a plusAligning 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 $108,000 to $153,000 (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.