Edwards Lifesciences · 20 hours ago
Senior Manager, Quality Engineering (2nd Shift)
USA - Minnesota – Minneapolis
Full-time
Onsite
Senior LevelEdwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. The Sr. Manager, Quality Engineering position involves managing project activities, providing technical guidance, and leading the implementation of quality assurance programs to ensure the highest standards of safety and integrity in product development.
BiotechnologyHealth CareMedicalMedical Device
Responsibilities
Manage project activities with the accountability for successful completion of all deliverables to the business and develop project plans, schedule, scope and objectives while using engineering methods (e.g., SIX Sigma and LEAN methods), employing technical design skills to re-design/design on new products and/or processes. Identify risks, develop mitigation strategies, define alternative solutions, resolve issues, and follow-up on action items in collaboration with cross functional groups
Manage and/or oversee the work of assigned team within own function and/or cross functional project teams and may have some budgetary responsibilities. Develop a robust talent development plan in alignment with functional growth strategies of the department
Provide technical guidance to cross-functional and/or departmental groups to develop and provide design recommendations that integrate into component(s) or product(s) with moderate complexity
Lead the implementation of CAPA program including training, approvals, and system effectiveness
Other incidental duties
Qualification
Required
Bachelor's Degree in related field, related experience in engineering or equivalent work experience based on Edwards criteria Required
Experience in Quality Engineering, Quality Management, and/or Regulatory Compliance within the medical device industry or equivalent work experience based on Edwards criteria Required
Demonstrated track record in management of technical and/or engineering disciplines or equivalent work experience based on Edwards criteria Required
Preferred
Experience working in a regulated industry or equivalent work experience based on Edwards criteria 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 addressing issues with impact beyond own team based on knowledge of related disciplines
Expert understanding of related aspects of quality engineering processes and/or systems
Expert knowledge of domestic and international regulatory requirements (e.g., FDA, GMPs, and ISO/EN standards)
Expert knowledge of design of experiments, process capability studies, failure mode and effects analysis, statistical process control, industrial statistical methods and Lean Manufacturing
Knowledge of financial acumen as it relates to the business as well as quality 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 quality 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
Frequently interacts with subordinate production supervisors, customers, and/or functional peer group managers, normally involving matters between functional areas, other company divisions or units, or customers and the company; often leads a cooperative effort among members of a project team
Participate and present at meetings with internal and external representatives
Resolve operational and scheduling issues
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
Company
Edwards Lifesciences
Edwards Lifesciences is a provider of science of heart valves and hemodynamic monitoring.
Founded in 1958
10001+ employees
H1B Sponsorship
Edwards Lifesciences has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (81)
2024 (70)
2023 (42)
2022 (65)
2021 (44)
2020 (28)
Funding
Current Stage
Public CompanyTotal Funding
unknown2000-04-03IPO
Leadership Team
Bernard J. Zovighian
Chief Executive Officer
Andrew Greene
Vice President, Strategy
Recent News
2026-02-04
bloomberglaw.com
2026-01-20
BioWorld Financial Watch
2026-01-15
Company data provided by crunchbase