Innovation starts from the heart. Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. With millions of patients served in over 100 countries, each team makes a meaningful contribution by improving patient outcomes and discovering lasting solutions for unmet patient needs. Our Manager, Supplier Development Engineering (people leader) position is a unique career opportunity that could be your next step towards an exciting future.
You’ll make an impact by:
• Position will reside in the Transcatheter Heart Valve (THV) Supplier Development Engineering team to provide manufacturing engineering support in the design and development of implantable devices and delivery systems to treat cardiovascular disease.
• Conduct engineering activities from the initial product development phase through product launch.
• Provide technical input for strategic sourcing projects, including evaluation of supplier capability, part qualification plan, specification review, product implementation and part transition to manufacturing.
• Develop manufacturing technologies to meet new product demands.
• Support manufacturing readiness reviews, supply chain readiness reviews, and manage design transfers to production environment.
• Manage product phase in/phase out activities around design, regulatory and clinical requirements.
• Lead supplier validation activities, support milestone builds and commercialization of new product introduction. Integrate new products into manufacturing.
• Conduct reviews to ensure DFM considerations are incorporated into designs. Assess and develop supplier part capability.
• Participate in technical discussions with suppliers to identify and implement improvements in products and processes.
• Perform design and drawing reviews to ensure that components meet desired capabilities for manufacturing.
• Responsible for defining supplier qualification requirements for OEM, Contract manufacturer (components and devices) and custom materials, including supplier validations
• Lead recurring technical meetings with critical outsourced component/ assembly suppliers
• Respond with a high sense of urgency to quality issues and escalate / communicate appropriately.
• Ensure that Tier 1 suppliers are using capable Tier 2 suppliers and resolve any inter-company conflict effectively
• Strategically bring various cross functional teams and suppliers in alignment on outstanding issues in a timely manner.
• Work with suppliers to optimize processes, reduce cost, ensure lean manufacturing as well as remove any waste from processes.
• Develop and manage project milestones in line with development and commercialization needs.
• Perform supplier risk & capacity assessment and take appropriate actions to ensure timely and successful commercialization
• Audit suppliers for their technical capabilities as well as quality criteria.
• Perform other duties and responsibilities as assigned.
• Manage and/or lead a small team within assigned function. Develop team members to increase business acumen and functional skills
• Plan and direct assigned operational and project activities with the accountability for successful completion of assigned deliverables
• Identify opportunities and lead the implementation of changes to drive improvements
• Work on complex issues where analysis of issues requires in-depth knowledge
• Create/update complex engineering documents including requirement specs, and risk documents with robust knowledge on design control requirements
• Oversee engineering tasks; provide technical guidance and feedback to technicians/engineers; Guide lower level employees on more complex procedures
What you’ll need (required):
• Bachelor's Degree in a related field and experience in engineering
What else we look for (preferred):
• Master’s Degree in a related field and 5-6 years of Engineering experience
• Demonstrated track record in management of technical and/or engineering disciplines.
• Experience working in a regulated industry
• Ability to manage technical and/or engineering disciplines and demonstrated informal mentoring and/or peer leadership skills
• Proven successful project management 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
• Extensive understanding of engineering procedures while defining team operating standards
• Extensive understanding of related aspects of engineering processes and/or systems
• Basic financial acumen as it relates to engineering (e.g., material and capital expenditures and product costing)
• Demonstrated skill set to manage small team 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 influence cross-functional partners
• Ability to integrate metrics into the projects and operations
• 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
• Primarily interacts with internal subordinates and other supervisors
• Typically interacts with external suppliers, vendors and/or customers
• Share information and provides basic problem solving solutions; gains cooperation of others, conducts presentations of technical information concerning specific projects or schedules
• 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
• 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
For California (CA), the base pay range for this position is $118,000 to $167,000 (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.