Manufacturing Engineer Digital Transformation Kelly Services - 3.8 Irvine, CA Job Details Full-time $60 an hour 16 hours ago Benefits Paid holidays Disability insurance Health insurance Dental insurance 401(k) Paid time off Vision insurance Paid sick time Qualifications Meeting minutes Project reporting Data integrity assurance Feature prioritization Compliance risk assessment Committee work Quality management standards in production Requirements design Procedural guides IT transformation Pharmaceutical regulatory compliance Employee training Enterprise solutions implementation

FDA 21 CFR

Part 11 Mid-level Project management experience in manufacturing Project communication management 3 years Manufacturing standard operating procedures Manufacturing facility experience Data integrity and documentation Bachelor's degree in engineering Medical device manufacturing facility experience Task prioritization Pharmaceutical company experience System validation User acceptance testing Requirements management Production management systems implementation Leading team collaboration initiatives Full Job Description Kelly Engineering is seeking a Manufacturing Engineer, Electronic DHR Implementation Lead for a long-term contract with one of our Global Medical Device clients located in Irvine, CA . Our Client is a global leader in the science of diagnosing and treating heart rhythm disorders. The company partners with clinicians to develop innovative technologies that improve the quality of care for arrhythmia patients worldwide 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 visas at this time. As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources.

Please note:

The following benefits reflect Kelly's general offerings. Eligibility may vary by assignment, location, and job type. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Why Kelly® Engineering/Technology - Project Services? Looking to work with leading project management organizations at top companies around the world? That's where we come in. At Kelly Engineering and Kelly Technology, our Project Services Teams create expert talent solutions to solve the world's most critical challenges. We connect you with opportunities to work on intriguing, innovative, and high-visibility projects-all with a schedule that works for you. Do you prefer the variety and flexibility of short-term projects? Or are looking for a long-term opportunity? Either way, our connections and expertise will help you take your career exactly where you want to go. That's just good planning. About Kelly Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life-just ask the 300,000 people we employ each year. Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S. Kelly may use AI-powered tools during the recruitment and hiring process. For full details, including how Kelly uses AI, your rights, and how to request a reasonable accommodation, visit the Recruitment Artificial Intelligence Notice.