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USA - California – Irvine, United States of America
Onsite
Innovation starts from the heart. At Edwards, we put patients first. We invest a significant proportion of our revenue towards research and development to drive and develop groundbreaking medical innovations for structural heart disease. As part of our R&D Engineering team, you will work closely with our Quality and Manufacturing teams to support and develop the latest tools and technologies to address significant, unmet clinical needs that impact patients’ lives around the world.
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.
How you will make an impact:
Through vision, collaboration, and cross-functional engagement, this individual in this role will lead all aspects of R&D product lifecycle management related activities including corrective and preventative activities, patient monitoring, new product introductions, design and process changes, quality improvements, regulatory compliance, and cost optimization. It will foster creative and accountable application of professional knowledge, skills, and experience in sustaining products and implementing improvements that match the strategic goals of the organization. In this role you will have the opportunity to drive device improvements and manage engineering team members. The ideal candidate would be well-versed with cross-functional teams while also participating in hands-on engineering work. Your responsibilities will include, but are not limited to:
Manage all engineering aspects of the product life cycle including design changes, product enhancements, and component obsolescence management.
Develop and implement strategic plans for sustaining engineering activities that align with over company objectives.
Provide regular updates on product issues, assigned KPIs, and technical initiatives to upper management on an ongoing basis.
Strengthen and expand engineering technical services through process improvement.
Hire, train, coach and review the work of a team of engineers from diverse disciplines.
Monitor and evaluate product performance and continuously improve all product components to improve overall product performance and end user experience.
Provide strategic direction, insights, and decisions governing team and project priorities based on business needs, risks, and corporate goals.
Ensure proper design documentation and adherence to QMS for design documentation and processes.
Support in the preparation of regulatory documentation filings, including necessary design documentation and V&V reports.
Lead team in root cause investigations and corrective and preventative actions. Implement risk management processes and tools and mitigate risks.
Collect, interpret, analyze, and present field performance data including impact on device performance and develop data-backed solutions.
Hire and lead/direct the work of other employees including performance management.
Other incidental duties
What you'll need (Required):
Bachelor's Degree in related field with related experience in engineering and skill levels exceeding the requirements of the previous level
Demonstrated track record in management of technical and/or engineering disciplines
Experience with class II and/or class III medical products in an engineering leadership role
What else we look for (Preferred):
Experience managing cross-functional engineering teams, including data, mechanical, and electrical disciplines.
Experience managing direct reports
Hands-on leader - Ability to lead teams while also participating in design/development
In-depth knowledge of mechanical design, electrical engineering, and data analytics principles and practices
Experience in medical products with both hardware and data and/or software is preferred
Proven successful project management leadership skills
Knowledge and understanding of relevant medical device regulations (21 CFR Part 820), and standards (ISO 13485, IEC 62304) and experience with FDA submissions for product approvals.
Excellent problem-solving, organizational, analytical and critical thinking skills including high discretion/judgment in decision making
Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
Knowledge of financial acumen as it relates to the business as well as engineering
Demonstrated ability to direct teams and provide coaching and feedback, including responsibility for all employee actions including hire/fire authority and partnering with HR on all aspects of employee relations
Ability to develop and integrate metrics into the projects and operations that clearly demonstrate the value of engineering to the business
Serve as core partner to senior leaders in Business Units, Functional Groups, Regions and IT
Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization
Ability to work and excel within a fast paced, dynamic, and constantly changing work environment
Interacts with senior management, and others concerning matters of significance to the company
Conduct business and technical briefings for senior and top management and for external representatives
Regularly interacts with executives and/or major customers; interactions frequently involve special skills, such as negotiating with customers or management or attempting to influence senior level leaders regarding matters of significance to the organization
Dedicated to quality client service and pro-active and responsive to client needs.
Develop peer, cross functional and cross business relationships to maximize best practice sharing and team effectiveness.
Provide leadership and direction to large cross-functional teams to successfully implement global enterprise systems and related solutions
Develop relationships and leverage them to influence change
Support and solicit input from team members at all levels within the organization
Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
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 $159,000 to $226,000 (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.
