Research And Development Engineer

About the job

We are looking for a Senior R&D Engineer. The Access team is responsible for the development of sheath technologies for vascular delivery of our transcatheter devices to the patient. The Senior Engineer will play a key role in design and development of new vascular access devices while working closely with a broad cross-functional, domestic, and international team that includes valve and delivery system R&D, quality, clinical affairs, regulatory affairs, operations, and marketing, as well as interacting with clinical specialists and physicians.

Key Responsibilities:

• Other duties assigned by Leadership
• Assign R&D support tasks; give instruction to technicians on conducting tests; train technicians and provide feedback; and coordinate technician work
• During the first year, there may be an increased amount of domestic and international travel
• Create/update more complex design control documents including requirement specs, and risk documents
• Create, test, and/or improve products by developing complex experiments and tests (including writing and executing protocols), analyze results, make recommendations, and develop reports, based on engineering principles
• Develop and execute engineering project plans
• Evaluate input and form a technical recommendation including designing parts, components and subsystems
• Identify, evaluate, manage, and provide guidance to suppliers, including establishing tolerances and defining acceptance criteria for suppliers
• Train, coach, and guide lower level employees on routine procedures
• Generate work instructions, test methods, engineering models and drawings/prototypes, etc., to establish/characterize product and/or process specifications

Required Qualifications:

• Experience must include: Designing and testing plastics and metals used in medical devices (including material characterization and manufacturing processes).
• Master's Degree in Engineering and 3+ years professional medical device experience
• Bachelor's Degree in Engineering and 4+ years of professional medical device experience – OR –

Preferred Qualifications:

• Knowledge of vascular surgical procedures and vascular anatomy strongly preferred
• Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing
• Ability to interact professionally with all organizational levels
• Good leadership skills and ability to influence change
• Strong documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills
• Basic understanding of statistical techniques
• Previous experience working with lab/industrial equipment required (if applicable)
• Substantial understanding and knowledge of principles, theories, and concepts relevant to Engineering
• Strict attention to detail
• Proven expertise in usage of MS Office Suite; CAD experience preferred
• Substantial understanding of processes and equipment used in assigned work
• Ability to manage competing priorities in a fast-paced environment
• Strong problem-solving, organizational, analytical, and critical thinking skills