Senior R&D Engineer

100% onsite no conversion / possible extension

Duties:

The Senior R&D Engineer will play a key role in support of clients' transcatheter aortic valve therapies. This role is responsible for leading and supporting key projects associated with commercialized THV products. This includes support of product configuration changes, providing design control expertise for supply-chain driven manufacturing improvements, leading investigations into field performance issues and support of product labeling and training updates associated with global therapy expansion.

Essential Job functions include:

• Provide Engineering input to THV commercialized product projects including application of design control and risk management Develop solutions to a variety or problems of moderate scope and complexity.
• Be a subject matter expert on field performance of THV devices and the design features associated with key performance metrics
• Apply mechanical and biomedical engineering principles to the design and development of components for the delivery system and accessories.
• Adaptable to broad scope of projects including material changes, manufacturing improvements, packaging and labeling changes, use instruction and usability changes. Develop test methods and procedures to evaluate device prototype performance.
• Assign support tasks; gives instruction to technicians on conducting tests; trains technicians and provides feedback; and may coordinate technician work.
• Build partnerships with key cross functional stakeholders
• Maintain accurate documentation of concepts, designs, drawings, and procedures. Generate written protocols, reports, and technical justifications/summaries.
• Other incidental duties assigned by Leadership

***Ignite (will be trained)

***Clinical knowledge of THV (Transcatheter Heart Valve) Devices

***Minitab exp ***Coordinating testing, drafting reports, data analysis, and historical data. ***Assisting with running test but if they have more exp they will probably call on to assist with drafting

***Engineering degree & experience with Medical Device.

***Turn-around to get someone onboard is ASAP.

Skills:

• Proven expertise in usage of MS Office Suite including MS Project; CAD experience preferred (if applicable)
• Strong documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills
• Experience utilizing statistical techniques to support design decisions and product acceptance testing
• Previous experience working with lab/industrial equipment required (if applicable)
• Experience with design controls, design verification & validation, or design test method development
• Substantial understanding and knowledge of principles, theories, and concepts relevant to Engineering
• Strong problem-solving, organizational, analytical and critical thinking skills
• Substantial understanding of processes and equipment used in assigned work
• Good leadership skills and ability to influence change
• Knowledge of applicable FDA regulations for medical device industry
• Strict attention to detail
• Ability to interact professionally with all organizational levels
• Ability to manage competing priorities in a fast-paced environment
• Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects
• Adhere to all rules and requirements 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
• Demonstrated experience reviewing and updating risk management related documents

Education and Experience:

Bachelor's Degree in Engineering with, 3+ years of experience including either industry or industry/education Required

or

Master's Degree 2+ years of experience including either industry or industry/education Required