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Principle Product Development Engineer Motion Recruitment - 3.7 Santa Clara, CA Job Details Contract 12 hours ago Benefits Commuter assistance Health savings account Disability insurance Health insurance Dental insurance Flexible spending account Vision insurance 401(k) matching Life insurance Paid sick time Qualifications Developing medical devices New product introduction engineering projects Product development project management System troubleshooting Medical device testing Design of experiments Presentations for conferences or internal meetings CAD design (engineering design task) Equipment troubleshooting Technical report writing Schedule management Engineering research Design engineering Prototype creation Design controls Managing projects Test Execution (Quality assurance practices) Research and development project management Test validation method Research findings presentation Research & development Mechanical product validation projects Prototypes Mechanical troubleshooting Product design documentation Full Job Description Principal R D Engineer / Medical Devices / Onsite / Santa Clara, CA Our client is a leading medical technology organization developing innovative products used in patient care. Based out of Santa Clara, California, they are looking to hire a Principal R D Engineer on a contract basis. This is an excellent opportunity for an experienced medical device engineer who wants to remain close to the actual product development process. Rather than supporting day-to-day manufacturing operations, you'll work hands-on with new and existing medical devices through design, prototyping, testing, troubleshooting and commercialization. You'll have significant ownership of your projects while collaborating with R D, Quality, Regulatory and Manufacturing teams and presenting technical results to senior leadership. Contract Duration 6 months with the possibility of extension Onsite in Santa Clara, CA 9:00 AM-5:00 PM PST Up to 20% travel Required Skills & Experience Minimum 7 years of medical device industry experience Strong R D and product development experience Working knowledge of Medical Device Design Controls and Design History File requirements Advanced CAD experience, preferably SolidWorks Hands-on medical device testing, troubleshooting and prototype development Ability to work independently and manage project timelines and deliverables Experience developing and executing test protocols and reports Strong mechanical aptitude and problem-solving ability Strong written, verbal and presentation skills Desired Skills & Experience Cardiovascular catheter delivery system or similar disposable medical device experience Experience with statistical study design including DOE and ANOVA Experience with IQ/OQ of laboratory equipment, preventative maintenance and calibration Experience with Class III medical devices, IDE and/or PMA Familiarity with GMP, QMS and domestic/international regulatory requirements CAPA and product lifecycle management experience High-volume production environment exposure Familiarity with AGILE What You Will Be Doing Tech Breakdown SolidWorks / CAD and fixture design Medical Device Design Controls / DHF Prototype development and device testing Bench-top test models and test method development Design verification and validation

DOE / ANOVA

/ statistical analysis IQ/OQ and laboratory equipment CAPA and lifecycle management FDA and international regulatory requirements Daily Responsibilities Lead R D activities supporting medical device product development, sustaining and lifecycle initiatives Perform hands-on prototype development, device testing, troubleshooting and laboratory work Manage engineering project timelines, deliverables and technical priorities Develop and execute test protocols and prepare technical reports Develop clinically relevant bench-top models and methods for evaluating device performance Analyze test data and communicate findings to cross-functional teams Coordinate with project management and cross-functional engineering teams to keep programs on schedule Work with Quality, Regulatory and Manufacturing to move products from concept through commercialization Manage Design Control activities and associated documentation in compliance with internal procedures and regulatory requirements Create samples supporting product development, marketing and manufacturing needs Develop technical presentations and communicate project results to senior leadership You will receive the following benefits: Medical Insurance - Four medical plans to choose from for you and your family Dental & Orthodontia Benefits Vision Benefits Health Savings Account (HSA) Health and Dependent Care Flexible Spending Accounts Voluntary Life Insurance, Long-Term & Short-Term Disability Insurance Hospital Indemnity Insurance 401(k) including match with pre and post-tax options Paid Sick Time Leave Legal and Identity Protection Plans Pre-tax Commuter Benefit 529 College Saver Plan Motion Recruitment Partners (MRP) is an Equal Opportunity Employer. All applicants must be currently authorized to work on a full-time basis in the country for which they are applying, and no sponsorship is currently available. Employment is subject to the successful completion of a pre-employment screening. Accommodation will be provided in all parts of the hiring process as required under MRP's Employment Accommodation policy. Applicants need to make their needs known in advance.