Principle Product Development Engineer

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.