Principle Product Development Engineer

About the job

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.