Project Engineer

Ambu; København; On-site; MXN 600,000 - 960,000; Full time

Job summary

Ambu A/S is seeking a qualified Injection Moulding Program Lead in Mexico to drive mould development, validation, and process control for production-ready components. You will coordinate cross-functional teams across R&D, tooling, and suppliers, translating design requirements into actionable mould specifications and ensuring alignment with global quality standards.

You will oversee BOM management in PLM and ERP, develop work instructions, and manage project milestones and budgets while

Qualifications

• Bachelor's degree or higher in Mechanical/related field or equivalent hands-on moulding experience.
• At least 3 years in injection moulding, tooling or related manufacturing.
• Knowledge of mould structure, injection moulding, and DFM principles.
• Experience in ISO 13485 or regulated QMS environments.
• Hands-on BOM creation, approval and maintenance in PLM/ERP.
• Ability to manage project deliverables and budgets across full lifecycle.
• Strong written/spoken English and Chinese communication.
• Ability to plan milestones, phases and parallel projects.

Responsibilities

• Lead mould development from design review through tool acceptance.
• Drive IQ/OQ/PQ validation of the injection moulding process.
• Coordinate DFM reviews with tooling, R&D and suppliers.
• Translate requirements into clear part/mould specs.
• Align measurement methods and acceptance criteria across sites.
• Own BOM for injection moulded components in PLM/ERP.
• Create and approve work instructions for production.
• Plan milestones and track project budget and risks.
• Investigate escalated technical issues and drive CAPA.
• Provide standard/reference samples for QC and release.

Skills

Moulding process knowledge

DFM principles

BOM management (PLM/ERP)

Project management

Cross-functional alignment

English/Chinese bilingual

Regulatory QMS ISO13485

Reading drawings and GD&T

CAD basics

Budget & cost control

Education

Bachelor's degree or higher in Mechanical Engineering or related field

Tools

AutoCAD

PLM/ERP systems

Microsoft Project

Job description

1. Mould development and process validation. Drive mould development through design review, mould trials and tool correction to tool acceptance. Drive the injection moulding process validation, covering IQ/OQ/PQ. Manage sample delivery to the receiving sites.
2. DFM review and technical judgement. Participate in and coordinate DFM (Design for Manufacturing) reviews for injection moulded components with the local tooling engineer, global R&D and external suppliers. Read part and mould drawings and form a technical position on part geometry, draft, wall thickness, gating, parting line, GD&T and tolerance stack-ups, confirming that the part design, the mould concept and the moulding process are consistent with one another and that the requirements remain achievable in mass production.
3. Requirement translation. Interpret the requirements placed on the injection moulded parts - as defined by the global R&D from the finished goods design and production perspective - and translate them into clear, actionable part and mould requirements. Where moulding or tooling constraints make a requirement unachievable, translate the resulting impact back onto the finished goods requirements and drive the part to a technically frozen definition.
4. Measurement alignment. Carry measurement methods, equipment and acceptance criteria from development through process validation into production, and hold incoming inspection at oversea sites to the same standard, so results are comparable wherever they are measured.
5. Cross-functional technical alignment. Understand the technical priorities and constraints of each party involved - the assembly and production needs of the sister site, R&D's design intent, and the supplier's toolmaking capability - and, where these conflict, reconcile them into one agreed part definition.
6. BOM. Own the BOM for injection moulded components, including creation and approval in PLM and setup in ERP.
7. Work instructions. Own the creation and approval of work instructions within this role's scope.
8. Project planning and execution. Build the complete project milestone plan and detailed phase schedule for the injection moulded component scope, covering mould development, sampling and process validation. Ensure alignment with, and contribution to, the global project plan, and that critical project activities are executed on schedule. Monitor, record and archive project activities in line with the company quality system and applicable regulatory requirements. Report progress, key issues and potential risks to the project sponsor team and stakeholders on a regular basis. Track project deliverables and monitor budget utilization throughout project execution, driving cost control on sample, tooling and external service costs for injection moulded parts.
9. Technical maintenance of parts in production. Own the technical maintenance of injection moulded components already in production, leading the investigation of escalated technical issues - those that routine quality and production troubleshooting cannot resolve and those without precedent (for example, an unexplained discolouration such as yellowing with no prior history on the part). Consolidate inputs from tooling, quality and production to establish root cause, and drive the agreed corrective actions and the associated change control to closure.
10. Standard or reference samples. Provide and renew the standard or reference samples for QC reference, issuing the reference sample before new products are released to production and renewing it when the sample passes its expiry date or otherwise needs updating.

Minimum Requirements

1. Bachelor's degree or above in Mechanical Engineering, Materials Forming and Control Engineering, Polymer Materials and Engineering, Materials Science and Engineering, or a related discipline; or equivalent hands-on injection moulding experience.
2. At least 3 years of experience in injection moulding, tooling or a related manufacturing environment.
3. Working knowledge of mould structure, injection moulding process and DFM principles - sufficient to follow the technical assessments of the tooling function and of global R&D/NPI teams, form an integrated judgement across mould, process and finished-goods requirements, and lead those functions to a common technical position on the part.
4. Experience working within a regulated quality management system (such as ISO 13485), including document control, change control and process validation.
5. Hands-on experience creating, approving and maintaining BOMs in PLM and ERP systems.
6. Ability to manage project deliverables and monitor budget utilization across the full project lifecycle, including control of sample, tooling and external service costs.
7. Good written and spoken communication in both Chinese and English, with the ability to convey technical content clearly.
8. Ability to build and maintain project milestone and phase plans.
9. Ability to run several projects in parallel - prioritizing across them, resolving resource and schedule conflicts, and managing workload effectively.

Preferred Qualifications

1. Knowledge of FDA QMSR and EU MDR requirements.
2. Good knowledge of design control and design change control, and of risk management in line with ISO 14971.
3. Good knowledge of plastic materials - shrinkage behaviour and material selection - and of injection moulding process parameters.
4. Basic CAD skills (e.g. AutoCAD) - sufficient to produce and revise packaging drawings, e.g., carton structural drawings.
5. Hands-on experience with Agile and Infor M3, or equivalent systems.
6. Proficiency in Microsoft Project for building and maintaining project plans and schedules.
7. Experience in the medical device industry.
8. Basic understanding of capital expenditure (CAPEX) and operational expenditure (OPEX).

About Ambu

Ambu has been bringing the solutions of the future to life since 1937. Today, millions of patients and healthcare professionals worldwide depend on the efficiency, safety and performance of our single-use endoscopy, anaesthesia, and patient monitoring solutions. We continuously look to the future with a commitment to deliver innovative quality products that have a positive impact on patient care and the work of healthcare professionals. Headquartered near Copenhagen in Denmark, Ambu employs approximately 4,500 people in Europe, North America and the Asia Pacific.