Kelly Engineering is seeking a Manufacturing Engineer, Electronic DHR Implementation Leader (Design History Record) for a long-term contract with one of our Global Medical Device clients located in Irvine, CA.

Our client is the global leader in the science of diagnosing and treating heart rhythm disorders. 

As a Kelly employee, you will be eligible for Medical & Dental 50% paid, 401K and a variety of other benefits to choose from.   You will also be eligible for paid time off, including holiday, vacation and sick/personal time.  All KellyOCG employees receive annual performance reviews

Manufacturing Engineer-Electronic DHR Implementation Leader
Lead the business-side delivery and adoption of an electronic Device History Record (eDHR) using MES for non-production processes.
Ensure the MES-based eDHR meets regulatory, quality and data-integrity requirements while enabling efficient production and traceability.
Candidates must demonstrate initiative, effective collaboration, strong critical thinking, clear communication skills, and consistent follow-through to resolve issues and complete the project.

Responsibilities:

• Lead the implementation of eDHR using MES from initiation to completion, applying appropriate Project Management methodologies and practices.
  

• Plan and manage detailed Project schedules with all critical milestones, interdependencies, and resource constraints.
  

• Coordinate cross-functional governance: convene steering committees, manage executive reporting, meeting minutes track milestones and escalate risks/issues.
  

• Translate high-level business needs into clear user requirements and acceptance criteria; prioritize features based on compliance risk and operational value.
  

• Drive / support business validation activities (UAT oversight, sign-off, etc), ensuring user acceptance reflects real-world production scenarios.
  

• Own business readiness: change management, SOP updates, process redesign, role definitions, and training strategy for impacted functions (manufacturing, quality, supply chain).
  

• Deliver transparent, timely and effective verbal and written communication and lead training sessions (workshops, job aids) for teams, stakeholders and appropriate levels of the organization.
  

• Champion regulatory and quality alignment by ensuring business decisions support 21 CFR Part 11, EU MDR, ISO 13485 and internal audit expectations.

Experience & Skills:

• University/Bachelor’s Degree or Equivalent in Engineering or related field (or equivalent experience)
  

• 3-5 years in product/program/program/project leadership within regulated manufacturing (medical devices, pharma), experience leading digital transformation MES/eDHR programs from the business side.
  

• Experience working in a Manufacturing environment.
  

• Strong understanding of medical device quality systems and regulatory drivers affecting DHR and manufacturing records.
  

• Excellent verbal and written communication and presentation skills, strong interpersonal abilities, and effective organizational and leadership skills.
  

• Ability to handle multiple priorities effectively.
  

• Travel to Suarez, MX possible.

Applicants must be legally permitted to work in the United States immediately and without employer sponsorship.  Not accepting H1B Visa’s at this time.

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