Our Mayo based client are seeking an experienced Engineering Project Manager to lead cross-functional projects focused on new product development, process improvement, equipment implementation and commercialisation within a highly regulated manufacturing environment.
This is an excellent opportunity for an experienced Project Manager looking to take ownership of complex, cross-functional projects within a highly regulated manufacturing environment.
Responsibilities
- Lead cross-functional project teams from development through to commercialisation.
- Develop and manage project plans, schedules, budgets, resources and timelines.
- Coordinate activities across Engineering, Operations, Quality, Suppliers and other key stakeholders.
- Identify and manage project risks, issues and mitigation plans.
- Lead technical scope definition, equipment implementation and process development activities.
- Coordinate equipment and process qualification, validation and manufacturing transfer.
- Monitor project progress and communicate milestones, risks and outcomes to senior stakeholders.
- Manage supplier relationships and external project partners.
- Support capacity planning, cost reduction and continuous improvement initiatives.
- Ensure projects comply with quality, regulatory and design control requirements.
- Manage multiple projects simultaneously within a complex technical environment.
Requirements
- Bachelor's degree in Engineering or a related technical discipline.
- 5–8 years' experience in engineering/manufacturing, with at least 3 years' project or programme management experience.
- Experience within a regulated manufacturing environment.
- Experience in process development, equipment qualification and/or manufacturing transfer.
- Experience with automated production equipment and structured problem-solving methodologies.
- Knowledge of Lean, Six Sigma, DOE or statistical analysis is desirable.
- Strong project planning, analytical and organisational skills.
- Excellent communication and stakeholder management skills.
- Experience in medical devices, pharmaceuticals or another FDA/regulatory environment is advantageous.