Senior Manufacturing Engineer – Medical Device / Biologics

Irvine, CA 92619

Posted: 07/22/19 Employment Type: Direct Hire Industry or Function: Engineer Job Number: 19061002-TM Compensation: $100-110K

JOB #: 19061002-TM

KEY WORDS: manufacturing, engineer, IQ/OQ/PQ, validation, GMP, FDA, fixture design, documentation, process development, CAPA, risk management, biologics, medical device, orthopedic.

Job Duties: TriStaff is partnering with a growing class II medical device company in Irvine, CA to find a Manufacturing Engineer for its team. This person will be the sole Manufacturing Engineer for the company and will be responsible for supporting all FDA class I and class II medical device manufacturing activities. This will include fixture design, risk management activities, CAPA implementations, equipment verifications and validations, process development and improvements.

Salary Range and Bonus Potential: $100-110K annual salary

• 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, unique medical device products
• State of the art facility

Job Requirements:
• Bachelor’s degree in Engineering
• 5-7 years medical device manufacturing experience
• Biologics experience highly preferred but not required
• Experience working for a small company highly preferred
• Strong communication skills both written and verbal

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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