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.