Unknown Company

Principle Product Development Engineer

santa clara, ca • Posted 2 weeks ago
Onsite Contract Design & Development

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.

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Principle Product Development Engineer in santa clara at Unknown Company

This position is listed as contract and onsite.

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