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.