Sr. Quality Engineer, NPD IHFM

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. Its 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.
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 internationally

What youll need (Required):
Bachelors Degree in Engineering or Scientific field 4 years experience including either industry or industry/education or
Masters 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/education

What 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 plus

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 $108000 to $153000 (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.