Manufacturing Engineer

(none selected) | Direct Hire

Post Date: 11/18/17 Job ID: Linked In Manufacturing Engineer Industry or Function: Medical



Job Description

As a Senior Manufacturing Process Engineer, each day will offer new challenges as you tackle a variety of responsibilities, including Oversight of 4 existing engineers and 15 Contract employees. Managing all aspects of different projects and overseeing the machine operations, resolving issues on machines.  Experience with FDA documentation, validations, VFDA, QSR.


Job Duties:

  • Take ownership of project success for new and existing families of production.
  • Coordinate cross-functional teams to execute and document the manufacturing launch of new/legacy products.
  • Determine manufacturing processes required to accurately and efficiently make spinal implants, from raw material to final cleaning and shipment.
  • Interface with Quality Engineering to determine critical manufacturing process and control characteristics.
  • Develop and complete manufacturing documentation (pFMEA, control plan, process flow, work instructions, and inspection plans).
  • Perform research, design, and development of manufacturing processes including production flow, assembly methods, and production equipment.
  • Execute the Engineering Change Process for process updates and improvements.
  • Perform product/process analysis and troubleshooting for cost reduction, quality improvement, and improved efficiency.
  • Design, develop, test, source, and cost-justify various tools, machinery, and equipment for recommended manufacturing methods.
  • Coordinate and manage the estimating/quoting process.
  • Lead design for manufacturability analysis with CNC Programmers and Quality Engineers, and provide input to Development (Design) Engineers.
  • Support process validation by working with validation engineers to clarify methods, inputs, and outputs of processes or equipment.
  • Implement, maintain, analyze and react to various production data logs.
  • Participate in NCMR Process in containment, root cause analysis, and implementation of permanent corrective actions.

Job Requirements:

  • 5-10 years experience
  • Must have managed projects – to include financials and timelines
  • Proficient with Microsoft office

Preferred Qualifications

  • Proven ability and fluency in Print Reading and GD&T, Statistical Process Control, Lean Manufacturing, Six Sigma
  • Experience in 21 CFR 820 and/or ISO 13485 regulated environment
  • Experience in a CNC manufacturing environment is preferred.


Educational Requirements:

  • Bachelor’s degree (BS); in a technical engineering discipline.


For confidential consideration please send details to:


      Jill Martinellii

Director of Technical Recruitment

TriStaff Group | San Diego, CA 92122

Phone 858.597.0845 | Cell 858.220.1282

Jill Martinelli

I have the coolest job in the world! Defined: Recruit (1635-45); < French, stem of recruter, derivative of recrue new growth. I love this definition – it’s focus is on new growth. I help individuals, departments and organizations grow! As an industry generalist I have the opportunity to learn about the latest technology in real time and converse with the most intelligent, creative and educated people in their respective fields. What a gift to be able to learn from my clients and candidates who keep me current and ahead of industry technology trends while helping them grow their careers and teams. I cut my recruiting teeth by staffing Qualcomm Assemblers (I earned a Soldering Certificate – trained by Qualcomm’s then Production Manager) to Engineering and everything in between. I believe my greatest strength lies in my ability to learn a company and its products as if I work for them- because I do! This leads to the opportunity to build their teams across multi-disciplines, Engineering, Sales & Marketing, Quality, Materials, Operations and Management/C-Level, across multiple industries. (Medical device, Electronics, Green technology, DOD and Scientific) I have helped numerous startups as well as mature corporations grow their teams. My network of contacts has been built over 25 years and has proved invaluable as a resource in finding the best of the best for companies and candidates. Originally from Buffalo, NY (Go Bills!) I earned my BS from SUNY Oswego in Elementary Education (comes in handy as I do a lot of coaching!)
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