Careers that Change Lives
In this exciting role, you will support development of current and next generation drug-coated balloon (DCB) projects to treat peripheral vascular disease. These combination products integrate biotechnology, polymer science, and pharmaceutical molecules onto balloon platforms. The employee will be a member of multiple projects through different stages of the product development cycle, bringing products to commercialization.

A Day in the Life

Designs, develops, analyzes, troubleshoots and provide technical skills during research and product development. Supports the development of current and next generation drug-coated balloon (DCB) projects to treat peripheral vascular disease. Coordinates design engineering for next generation combination device products by developing feasibility studies to assess and design next generation combination products. Works on DRM & PPD based product development applying Green belt tools and principles to generate Voice of customer (Vox), predictability and associated testing. Provides FEA in design and testing by applying computational modelling to simulate effects of design changes or implementation. Works within regulations that govern Class II and Class III Medical Device products and Combination device (Drug and device) ISO 13485, ISO 10555 &FDA 21 CFR 820. Coordinates Medical Device product development through design control, test method development, optimization of manufacturing and assembly processes and mecmechanical property testing and characterization. Applies Design FMEA (Failure Mode and Effects Analysis), RCA (Root cause analysis investigation), DMAIC, DOE (Design of Experiments). Utilizes DRM (Design for reliability and manufacturing tools), Design optimization and 3D Additive manufacturing for design and prototyping. Performs Process validation and qualification activities to include Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ). Develops and optimizes novel deposition coating technology processes to include Metallic and Non-Metallic. Works on various designs and developments of Anatomical models, Implantable delivery systems and balloon-expandable systems to include stents and frames. Utilizes software platforms to include SolidWorks or Pro-Engineering, and Minitab.

Responsibilities may include the following and other duties may be assigned.

• Support the development and integration of new technologies into the CardioVascular product offering.
• Provide assistance to interdepartmental team for new product introduction.
• Take an active role in early stage design control activities leading to a first in man study (innovation, proof of principle, product development, process development, and equipment development) such that a robust pilot line that is scaleable and transferable to commercial manufacturing is achievable.
• Document research and development process through lab notebooks, engineering characterization studies, and test reports.
• Work with Regulatory Affairs (RA) to compile US and OUS regulatory submissions. Assist RA with answering subsequent questions from regulatory bodies.
• Design and develop new test methods and equipment specific to new products. Train technicians in new processes.
• Create document change orders (CO's) for design, materials, and process documentation.
• Work with Regulatory, Preclinical, Quality, and Manufacturing departments to create product performance, design, and manufacturing specifications.
• Perform competitive product analyses.
• Work with patent counsel to file and evaluate intellectual property.
• Interact frequently with all departments within organization and occasionally with external physicians, consultants, and vendors.
• Designs, develops, analyzes, troubleshoots and provides technical skills during research and/or product development.
• Designs studies to investigate specific life science questions within field of expertise.
• May be involved in product research and development and/or clinical trials.
• Translates research discoveries into usable and marketable products.
• Assist in the development of new combination products and components.
• Minimum travel requirement of 10%.

Must Have: Minimum Requirements

• Bachelors degree required
• Minimum of 2 years of relevant experience, or advanced degree with 0 years of experience

• Bachelor's Degree in Engineering (Chemical, Materials, Mechanical or Biomedical) or Chemistry
• Master's degree.
• 2+ years working in R&D, Quality and/r Manufacturing on combination medical devices.

• Experience in R&D, Quality and/or Manufacturing in a regulated industry, working through different phases of product development.
• Experience with test method validation.
• Knowledge of design of experiments (DOE) and statistical techniques.
• Class II and Class III Medical Device products and Combination device (Drug and device) ISO 13485, ISO 10555 & FDA 21 CFR 820.
• Design control, test methods development, process optimization, mechanical property testing and characterization.
• Design FMEA (Failure Mode and Effects Analysis), RCA (Root cause analysis investigation), DOE (Design of Experiments).
• Design optimization, 3D Printing and Rapid prototyping, D esign Reliability and Manufacturability (DRM) tools.
• Process validation, IQ, OQ, and PQ.
• Implantable delivery systems and balloon-expandable systems to include stents and frames.
• Proficient with SolidWorks or Pro-Engineering and Minitab.
• Complete understanding and wide application of technical principles, theories, and concepts toward product, process, and technology development and evaluation.
• Able to provide imaginative, thorough and practical technical solutions to a wide range of difficult problems, consistent with company's objectives.
• Successful collaboration as part of a cross-functional team.
• Background demonstrating strong self-motivation; able to works under only general direction, independently determining and developing approaches to solutions.
• Proficient with computer applications (i.e. Word, Excel, PowerPoint, Minitab, etc.).
• Ability to communicate well (both written and verbal).

About Medtronic

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future.

Physical Job Requirements

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. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)

Additional Information

• Posting Date: Nov 23, 2020
• Travel: Yes, < 25 % of the Time