Principle Product Development Engineer

Kelly Services; Santa Clara (CA); On-site; USD 103,000 - 121,000; Full time

Benefits offered by this job

Medical Insurance

Dental & Vision Benefits

401(k) with matching

Paid time off

Competitive compensation

Job summary

Motion Recruitment Partners is seeking an experienced Principal R&D Engineer for a contract role in Santa Clara, CA. You will lead hands-on product development, prototyping, testing, and troubleshooting of medical devices with cross-functional teams.

Onsite 9:00 AM-5:00 PM PST, up to 20% travel, 6 months with extension. The ideal candidate has 7+ years in medical devices, strong CAD (SolidWorks) skills, and expertise in DHF/Design Controls, with excellent communication and project management

Qualifications

• Minimum 7 years in the medical device industry.
• Strong CAD and testing experience.
• Knowledge of Medical Device Design Controls and DHF requirements.
• Ability to work independently and manage timelines.

Responsibilities

• Lead R&D activities for product development and lifecycle initiatives.
• Hands-on prototype development, device testing and troubleshooting.
• Develop and execute test protocols and reports.
• Coordinate with Quality, Regulatory and Manufacturing teams.
• Move products from concept through commercialization.
• Create technical presentations for senior leadership.

Skills

R&D experience

Design Controls

SolidWorks

Prototype development

Project management

Test protocols

Problem solving

Communication skills

Tools

SolidWorks

Job description

$75 - $88

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.

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.