Project Engineering Administrator

Job#: 3030888

Job Description:

JOB DESCRIPTION

The Project Engineering Administrator, R&D is responsible for end-to-end ownership and execution of R&D change orders in support of new product development, launch readiness, and sustaining production. This role serves as the primary author, owner, and driver of Engineering Change Orders (ECOs, PCOs, and, as applicable, QCOs, DCOs, and TCOs) within our client's Product Lifecycle Management (PLM) system.

The position works closely with Engineering Project Managers (EPMs), R&D and Production teams, and other change requestors to ensure change orders are authored correctly, routed efficiently, actively followed through approval, and completed in alignment with project timelines, regulatory requirements, and manufacturing readiness. Success in this role is measured by predictable execution, strong cross-functional coordination, and the ability to keep complex changes moving to closure.

Responsibilities:

Change Order Ownership & Execution

• Serve as the primary owner and author for R&D change orders, including ECOs, PCOs, and occasional QCOs, DCOs, and TCOs, from initiation through final approval and release.
• Author, route, monitor, and actively drive change orders through approval, including following up with approvers to resolve delays and ensure timely signatures.
• Partner with EPMs and change requestors to align change order content, timing, and approvals with project milestones, launch readiness, and production needs.
• Ensure change orders are structured correctly, include all required documentation, and comply with internal procedures and Quality System requirements.

Stakeholder Collaboration & Schedule Support

• Act as a key coordination point between R&D, Document Control, Manufacturing, Quality, Regulatory, and Supply Chain to support timely change execution.
• Proactively identify risks to change order timelines and escalate or mitigate delays that could impact launch or production schedules.
• Support engineering teams by translating technical inputs into compliant, well-structured PLM change records.

PLM Configuration & Documentation Management

• Manage and maintain product structures within the PLM system, including bills of materials (BoMs), Device Master Records (DMRs), drawings, labeling specifications, and related configuration items.
• Support the generation, maintenance, and traceability of Design History File (DHF) documentation as it relates to changes.
• Serve as an R&D subject matter expert for PLM change management processes, providing guidance on best practices and procedural expectations.
• Collaborate with Document Control to identify and implement efficiency improvements within the PLM change management workflow.

Additional Support

• Support creation and approval of Part Approval Plans (PAPs) for new components and suppliers as needed to enable change implementation.
• Assist R&D technicians with configuration control and documentation filing for development, verification, clinical, and pilot builds.
• Perform other administrative and coordination duties in support of R&D change management and product development activities.

Education and Experience:

Minimum Requirements

Two (2) years of higher education or equivalent experience in a technical or engineering-related discipline.

Minimum of 2 years of experience working with PLM systems, including managing product structures and engineering change orders.

Minimum of 2 years of experience in a cross-functional product development environment.

Demonstrated ability to own work end-to-end, prioritize competing requests, and drive closure in deadline-driven environments.

Strong understanding of Design Controls, configuration management, and product lifecycle management within a regulated Quality Management System (QMS).

Proven ability to collaborate across engineering, quality, manufacturing, regulatory, and supply chain organizations.

Preferred Skills and Competencies

• B.S. or equivalent degree in an engineering or technical discipline.
• Experience supporting FDA-regulated medical device development using processes aligned with ISO 13485, ISO 14971, IEC 60601, and IEC 62304.
• Demonstrated success supporting product launch, launch readiness, and sustaining production through disciplined change management.
• Strong organizational and communication skills, with confidence engaging senior engineers, EPMs, and functional approvers.

Physical Requirements (if applicable):

• This position is eligible for 100% remote work, with the option for hybrid on-site/virtual work as desired.

Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing in Talent Satisfaction in the United States and Great Place to Work in the United Kingdom and Mexico. Apex uses a virtual recruiter as part of the application process. Click for more details.

Apex Benefits Overview: Apex offers a range of supplemental benefits, including medical, dental, vision, life, disability, and other insurance plans that offer an optional layer of financial protection. We offer an ESPP (employee stock purchase program) and a 401K program which allows you to contribute typically within 30 days of starting, with a company match after 12 months of tenure. Apex also offers a HSA (Health Savings Account on the HDHP plan), a SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program and other discounts. In terms of professional development, Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA. Apex has a dedicated customer service team for our Consultants that can address questions around benefits and other resources, as well as a certified Career Coach. You can access a full list of our benefits, programs, support teams and resources within our 'Welcome Packet' as well, which an Apex team member can provide.