R&D Engineer - Senior
MedtronicAbout the role
At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
A Day in the Life
Medtronic’s Structural Heart & Aortic R&D group is looking for a motivated Senior Engineer to be part of a high-performing team that is revolutionizing the design and development of medical devices. In this role, you will leverage both your technical breadth and business acumen to maintain the design integrity of commercially available products. The work you do will impact patients globally and help support Medtronic’s mission of alleviating pain, restoring health, and extending life for millions.This position requires strong technical and leadership skills to support commercial product continuity and our global supply of products designed to treat diseases of the vascular system. The Sr. R&D Engineer will apply advanced engineering principles, theories, and concepts in working on complex technical problems and will provide technical leadership on post market objectives.
- Responsibilities may include the following, and other duties may be assigned:
- Develop design concepts/prototypes/test methodology to conduct material, component, and device level testing to meet development and regulatory requirements. Conduct design verification and validation testing per approved protocols and document in accordance with applicable development regulatory requirements. Collaborate with design colleagues to ensure designs are capable of meeting performance targets. Prepare regulatory submission-ready documentation for the FDA and other regulatory bodies. Support multiple projects within the Development group.
- Maintain product design integrity of commercially available products using sound engineering principles while working within appropriate Design Control requirements.
- Apply problem solving skills, critical thinking, technical principles, and theories to solve complex problems in the field of structural heart and aortic disease treatment;
- Investigating product design and reliability issues in partnership with other R&D Engineers, Manufacturing Engineers, Quality Engineers, and other cross-functional departments to determine root cause and implement solutions.
- Review and approve change orders of post-market products ensuring design integrity and reliability targets are met.
- Review and approve design and process qualifications.
- Review and approve verification and validation documentation.
- Oversee process development objectives of internal and external partners.
- Develop technical solutions and conduct testing, evaluate results using appropriate statistical analysis tools, and generate test reports;
- Work collaboratively with external suppliers and business partners as well as internal cross-functional team members to maintain post market product quality.
- Provide technical input supporting submissions to regulatory bodies
Nice to Have:
- High level proficiency of technical principles, theories, and design concepts in the field of medical device design
- Valve Design and Tissue processing experience a plus.
- Nitinol material and stent processing experience a plus.
- Experience with textile and suture development and testing a plus.
- Experience in design verification and validation.
- Experience with design and process qualification.
- Excellent written and verbal communication skills;
- Ability to lead others from a technical perspective while building a collaborative work environment.
Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)( 4)(iii)(A) and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.
Physical Job Requirements
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Co
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