Edwards Lifesciences is growing and our Senior Director, R&D Engineering, Endotronix position is a unique career opportunity that could be your next step towards an exciting future. This role will sit within the Endotronix team, who develop implantable heart monitoring technology. Endotronix was acquired by Edwards in July 2024, and will support our future work with heart failure management solutions to address large unmet structural heart patient needs and support sustainable long-term growth.For more details on the acquisition, please visit: https://www.edwards.com/newsroom/news/2024-07-24-edwards-lifesciences-expands-structural-heart-portHow you will make an impact:Through vision, collaboration, and cross-functional engagement, you will lead all aspects of product development activities including MEMS sensor design, mechanical design, and electrical hardware, development to ensure effective development of new products. You will foster creative and accountable application of professional knowledge, skills, and experience in implementing product improvements and innovations that match the strategic goals of the organization. In this role you will have the opportunity to drive device improvements that meaningfully impact patient lives and the care they receive. We wear many hats so you already know how to work fluidly on cross-functional teams while also participating in hands-on engineering work. Your responsibilities will include:
Manage all engineering aspects of the product life cycle including design changes, product enhancements, and component obsolescence management.
Develop and implement strategic plans and product roadmaps that align with company objectives.
Provide regular updates on product issues, assigned KPIs, and technical initiatives to upper management on an ongoing basis.
Hire, train, coach and review the work of a team of hardware, mechanical, and electrical engineers.
Monitor and evaluate product performance and continuously improve all product component technologies 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.
What you'll need (Required):
Bachelor's Degree in related field; related experience in engineering and skill levels exceeding the requirements of the previous level required; and
Demonstrated track record in management of technical and/or engineering disciplines required; and
Experience working in a regulated industry preferred
What else we look for (Preferred):
Deep engineering experience, with a strong background in medical device development. Experience in implantable sensors for cardiac monitoring preferred.
Experience managing cross-functional engineering teams, including sensor, mechanical, and electrical disciplines ,to successfully implement global enterprise systems and related solutions.
Clear and effective verbal and written communication skills
In-depth knowledge of MEMS sensor, mechanical design, electrical engineering, and principles and practices
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.
Hands-on leader - Ability to lead teams while also participating in design/development
Ability to establish relationships quickly with a broad range of constituents. Possess a collaborative style to work effectively throughout the organization.
Relevant practical experience and expertise in Class II or Class III medical device development is highly desired. Experience in medical products with both hardware and software is preferred.
Proven successful project management leadership skills
Proven expertise in both Microsoft Office Suite and related systems
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
Expert understanding of engineering procedures while looking beyond existing methodologies and own discipline to define and resolve complex problems
Expert understanding of related aspects of engineering processes and/or systems
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
Strict attention to detail
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
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.
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
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.COVID Vaccination RequirementEdwards 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.