Principal Project Engineer – Biologics/Medical Device – Irvine, CA

Irvine, CA 92618 | Direct Hire

Post Date: 07/23/18 Job ID: 69099-TM Industry or Function: Engineer Compensation: $ 120,000 to $ 150,000

JOB #: 69099-TM

KEY WORDS: medical device, FDA, biologics, orthopedic, spine, engineer, mechanical, product development, 510K, Design Control, Solidworks.

JOB DESCRIPTION: TriStaff is partnering with a small, innovative medical device company in Irvine, CA to find a seasoned Project Engineer for its team. This person will work autonomously but also collaboratively to develop products from concept through FDA approval. Biologics experience is highly preferred but not required. MEDICAL DEVICE EXPERIENCE REQUIRED

Job Duties:
• Manage projects using Design Control, develop timelines, lead meetings, and provide updates to upper management
• Design new products and processes
• Generate work instructions
• Validate new designs and processes
• Work directly with customers and surgeons
• Involved intimately with the FDA approval process

Salary Range and Bonus Potential:
$ 120,000 to $ 150,000

• 100% company paid medical, dental, and vision insurance
• 3 weeks PTO
• 401K Match
• Holiday pay
• Biweekly company lunches
• Opportunity to work with a close-knit group of people passionate about developing new medical device products

Job Requirements:
• Bachelor’s degree in Engineering
• 7-12 years medical device product development experience
• STRONG writing skills
• Biologics experience highly preferred

Educational Requirements:
• Bachelor’s degree in Engineering



Megan Marsh

I am an East Coast native and earned a BA degree in Psychology from the University of Virginia. After recruiting for a year in Washington, D.C., I moved out to San Diego, CA and joined TriStaff in 2007 as a Technical Recruiter. Since 2013, I’ve been an Engineering & Executive Search Recruiter, specializing in hardware engineering recruitment within Southern California. The majority of my clients are small, well-funded startups within the medical device and consumer electronics industries. Positions that I specialize in: Mechanical Engineers, Electrical Engineers, Quality Assurance, Manufacturing Engineers, Systems Engineers, Operations, Project Managers. I’m also the proud mother of two strong-willed daughters, and my husband is the Director of Operations at a local startup Medical Device Company, so I’m deeply embedded in the engineering space!
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