Providing 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 failure investigations for product failures in design testing and clinical use
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 10% domestically and internationally What you'll need (Required):
Bachelor's Degree in Engineering or Scientific field with a minimum of six (6) years related experience required; OR a Master's Degree in Engineering or Scientific field with a minimum of five (5) years related experience; OR a PhD in Engineering or Scientific field with a minimum of two (2) year related experience.
Knowledge of and experience with design control, risk management/usability engineering within medical device industry or other regulated industries
Working knowledge of the Domestic and International regulatory requirements of Medical Device regulations (FDA 21 CFR 820, ISO 13485, ISO 14971, ISO 62366; and other applicable regulatory requirements)
Must be able to work in a team environment, including inter-departmental teams and key stakeholders representing the organization on projects What else we look for (Preferred):
Current or prior experience within Medical Device industry
Quality Engineering experience in New Product Development
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).
ASQ Certified Quality Engineer (CQE), Quality System Lead Auditor, Certified Six Sigma Black Belt (CSSBB), or related quality/regulatory certifications a plus
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
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
Basic understanding of statistical techniques
Strong problem-solving, organizational, analytical and critical thinking skills
Experience in people leadership including direct line reporting responsibilities 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 $121,000 to $171,000 (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. Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. 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