Principal R&D EngineerMedtronic, Inc. - Irvine, CA
Principal R&D Engineer
Irvine, CA, 92604, USA
Principal R&D Engineer
Irvine, California, United States
Sep 19, 2017
**Do meaningful work, make a difference, and improve lives – starting with your own.**
RTG (Restorative Therapies Group) Overview
The Restorative Therapies Group develops life-restoring therapies and healthcare solutions that span the care continuum; integrating technologies and applying clinical and economic evidence to increase patient access, improve efficiency of procedures and deliver successful patient outcomes.
SPINE shapes spine surgery for the better; delivering procedural solutions and therapeutic biologics and partnering with other healthcare stakeholders to accelerate innovations that can improve surgical efficiencies and help create better outcomes for more patients.
BRAIN THERAPIES offers an integrated portfolio of devicesand therapies for the treatment of neurological disorders and diseases, as well as surgical technologies designed to improvethe precision and workflow of neuro procedures.
PAIN THERAPIES offers solutions — from early interventional procedures to implantable surgical technologies — that treat chronic pain as well as pain from spinal fractures, cancer and severe spasticity.
SPECIALTY THERAPIES offers a broad portfolio that addresses urologic and gastrointestinal disorders, conditions of the ear, nose and throat, as well as electrosurgical products for soft tissue dissection and hemostatic sealing of soft tissue and bone.
This position will primarily support the New Product Development activities for the Medtronic Neurovascular division. The product categories supported will be Intravascular large bore catheters, micro catheters, balloon guide catheters and guide wires. The position will lead and oversee one or multiple projects from conception to launch.
•Oversees projects from conception to implementation
•Defines product requirements, and schedules project deliverables for RD
•Develops and refines designs and determines tests required
•Works cross functionally with Process Development, Quality, Regulatory, Marketing and Clinical
•Travel required up to 20% (both domestic and international)
•Examples of Essential Functions (Including but not limited to):
•Designs, develops, and refines new products.
•Defines product requirements.
•Reviews existing patents to determine infringement status.
•Provides technical expertise for development projects.
•Schedules, coordinates and manages multiple projects.
•Assists in the transfer of newly developed products from RD to production.
•Determines, outlines, and interprets tests to verify product integrity in the design phase.
•Supervises and directs Engineers and Technicians
•Implementing designs, performing and documenting test results.
•Develops and maintains association with outside organizations and institutions pertinent to the interests and needs of the department and the Company.
•Interfaces with physicians to understand specific needs and develops solutions.
•Identifies and coordinates animal studies.
_IN ORDER TO BE CONSIDERED FOR THIS POSITION, THE FOLLOWING BASIC QUALIFICATIONS MUST BE EVIDENT ON YOUR RESUME_
•Bachelor’s degree in engineering with 7-10 years engineering work experience in disposable and implantable devices
•Experience with PDP process as a core team or extended team member
Years of Experience
10 years with Bachelor’s degree
6 years with Master’s degree
4 years with PhD
Specialized Knowledge or Skills Required
•Expert knowledge in materials associated with medical devices such as polymers (nylons, polyethylene, polypropylene, PEEK, Pebax, PTFE, FEP, polycarbonate, etc.) metals (stainless steel, aluminum, nitinol, etc.), ceramic, fiber, composites, etc.
•Expert knowledge in processes associated with medical manufacturing such as shrinking (reflow), RF welding, laser bonding, laser welding, thermal bonding, adhesive bonding, braiding, coil winding, insert molding, hydrophilic coating, plasma treatment, cleaning processes, cutting/skiving/slitting, crimping, etc.
•Expert knowledge of center-less grinding processes and equipment as applied to various wire and mandrel materials and profiles.
•Expert knowledge of polymer extrusion processes and equipment including medical polymeric materials, diameters ranging from 1.0 – 16 French, single and multi-lumen profiles, co-extrusion applications, bump tubing, striping, etc.
•Experience with medical device based products and processing and technologies.
•Good verbal and written communication skills.
•Application of statistical and analytical methods such as SPC, SQC, and DOE.
•Test protocol generation, execution, and reporting
•Coating process experience or Materials Engineering experience preferred.
•Medical Device/Pharmaceutical Industry experience preferred.
•Basic reading and engineering level math
•Reading and producing drawings
•Excellent written and verbal communication skills
•Computer literate; use of word processing, Spreadsheets, Autocad
•Reading and interpreting patents
•GMP and ISO 9000 training
•Recognize problems and take corrective measures
**Proficient in design and process FMECA, Process Validation and variability reduction applications.**
**Equipment and tooling design**
**Supervisory and motivational skills**
**Project management associated with new process/product development and the successful transfer into manufacturing.**
**Implementation and support of Lean Manufacturing, Demand Flow, Total Quality tools**
**Process background (development, capability, optimization, validation) within a regulated industry**
**Development of manufacturing documentation (MP, IP, BOM)**
**Development and qualification of tooling/equipment (IQ/OQ/PQ, support, design)**
**Manufacturing continuous improvement support**
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology 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 can 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.
This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here: http://www.uscis.gov/e-verify/employees
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
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13 days 6 hours ago
applyPrincipal R&D Engineer Medtronic, Inc. - Irvine, CA, United States
Medtronic, Inc. manufactures and sells device-based medical therapies worldwide. The company operates in two segments, Cardiac and Vascular Group, and Restorative Therapies Group. The Cardiac and Vascular Groups products include pacemakers; implantable defibrillators; leads and delivery systems; ablation products; electrophysiology catheters; products for the treatment of atrial fibrillation; information systems for the management of patients with cardiac rhythm disease management (CRDM) devices; coronary and peripheral stents and related delivery systems; therapies for uncontrolled hypertension; endovascular stent graft systems; heart valve replacement technologies; cardiac tissue ablation systems; and open heart and coronary bypass grafting surgical products. The Restorative Therapies Group offers products for various areas of the spine; bone graft substitutes; biologic products; trauma, implantable neurostimulation therapies, and drug delivery devices for the treatment of chronic pain, movement disorders, obsessive-compulsive disorder (OCD), overactive bladder, urinary retention, and fecal incontinence and gastroparesis; external insulin pumps; subcutaneous CGM systems; products to treat conditions of the ear, nose, and throat; and devices that incorporate advanced energy technology. It also manufactures and sells image-guided surgery and intra-operative imaging systems; and provides Web-based therapy management software solutions. The company serves hospitals, physicians, clinicians, and patients in approximately 140 countries. Medtronic, Inc. was founded in 1949 and is headquartered in Minneapolis, Minnesota.
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