Senior Manager, R&D Engineering, Surgical

In this role, you will be responsible for designing and developing surgical devices to help cardiovascular patients. This is an exciting opportunity to provide leadership to a team of designers and engineers working on the product development initiatives for Edwards Lifesciences Surgical R&D Team.

We are seeking a Senior Manager, R&D Engineering, Surgical, who is passionate about making a difference in the lives of patients and thrives in a fast-paced, cross functional, and dynamic environment.

Key Responsibilities:

• Manage project activities with the accountability for successful completion of all deliverables to the business and develop project plans and schedule, scope, and objectives. Identify risk, develop mitigation strategies, alternative solutions, resolve issues, action item follow up, etc. in collaboration with cross functional groups.

• Perform as a subject matter expert in the fields of design in CAD, FEA, and design testing.

• 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.

• Proactively identify issues, achieve resolution, and resolve problems of significant complexity on designing parts, components, and subsystems

• Create/update complex design control documents including requirement specs, and risk documents with robust knowledge on design control requirements.

• Lead cross-functional and/or departmental groups to develop and provide design recommendations that integrate into component(s) or product(s) with moderate complexity.

• Develop project plans to assess technology and drive project results.

• Other incidental duties

Education & Experience Required:

• Bachelor’s degree in mechanical engineering with 8+ years of related experience is required -OR-

• Master's Degree or equivalent in mechanical Engineering with 7+ years of related experience is required -OR-

• Ph.D. or equivalent in Engineering or Scientific field with 4+ years of related experience is required.

Required Qualifications:

• Demonstrated track record in management of technical and/or engineering disciplines.

• Experience working in a medical device industry.

• Proficient in CAD (Solidworks or Creo preferred)

• Experience with FEA

Preferred Qualifications:

• Master’s degree in mechanical engineering

• FEA in depth knowledge with at least 2+ years of experience

• Experience working with regulatory authorities, notified bodies and other industry standards.

• Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives.

Additional Skills:

• 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 engineering processes and/or systems

• Ability to develop and integrate metrics into the projects and operations that clearly demonstrate the value of design group to the business.

• Knowledge in cGMP Manufacturing Environmental within Medical Device Industry, including knowledge of FDA / TUV guidelines and quality system regulations in general.

• Extensive knowledge and understanding of principles, theories, and concepts relevant to Engineering.

• Knowledge of financial acumen as it relates to engineering.

• Demonstrated ability to manage assigned 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, business units, and/or sites.

• Strict attention to detail

• Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management