We are seeking a versatile and results-driven Project Manager to lead and manage a variety of projects including the integration of new business opportunities, internal operational enhancements, and digital transformation efforts. The ideal candidate will thrive in a hands-on, fast-paced environment, balancing technical expertise with a pragmatic, problem-solving mindset. This is an on-site role, requiring strong project ownership from conception to delivery within the regulated standards of the medical device sector.
Key Responsibilities
Project Management:
- Lead client development projects such as technology transfers (tech transfers) and new product introductions (NPI).
- Lead the integration of new business opportunities into existing manufacturing operations.
- Oversee internal operational projects, including cleanroom setups, relocations, and facility expansions.
- Plan and manage digital transformation projects, ensuring alignment with organisational goals.
- Develop and manage project budgets, ensuring cost-effective delivery without compromising quality.
- Prepare and facilitate retrospectives to drive continuous improvement.
 Manufacturing Operations:
- Ensure seamless project execution within a cleanroom and regulated manufacturing environment.
- Understand change control and document control/record management in a medical device development and manufacturing environment.
- Collaborate with operations teams to resolve challenges and ensure process scalability.
- Support and implement principles of Kaizen and Six Sigma to optimise workflows.
Compliance and Risk Management:
- Identify, evaluate, and mitigate project risks, adhering to ISO 14971 standards for medical devices.
- Maintain compliance with ISO 13485, customer requirements, and regulatory standards.
- Strengthen internal processes to uphold a robust risk management framework.
Stakeholder Communication:
- Provide regular project updates to internal and external stakeholders, highlighting progress, risks, and mitigation plans.
- Build strong internal and external relationships to support collaboration and long-term success.
Continuous Improvement:
- Actively identify and implement opportunities for improvement across projects and manufacturing operations.
- Lead initiatives in process optimisation, leveraging tools like retrospectives and continuous feedback loops.
Key Skills and Experience
- Proven track record of managing client development projects (NPI, tech transfers) and operational initiatives (cleanroom setups, relocations).
- Demonstrates self-sufficiency and adaptability, able to function effectively without reliance on extensive PMO structures.
- Experience in handling and optimising project budgets.
- Hands-on experience in manufacturing environments, particularly cleanrooms.
- Proficiency in ISO 13485 and risk management under ISO 14971.
- Familiarity with Kaizen, Lean principles, and Six Sigma methodologies.
- Proficient in project management tools, including Microsoft Project, with a strong aptitude for leveraging technology to streamline workflows.
Desirable Attributes
- Knowledge of medical device validation and regulatory pathways.
- Strong interpersonal and leadership skills to manage diverse teams and stakeholders.
- Proficiency in leading internal transformation initiatives, including digital optimisation projects.
Further Information
This will be an office-based role which will require a presence at our Southminster site 5 days per week.
At Europlaz, we provide an inclusive and flexible working environment for people to thrive in, and we are happy to support flexible working wherever possible. In return for your hard work, we offer a competitive package that includes an enhanced salary sacrifice pension scheme, life assurance and an incentive bonus. We encourage you to apply and embark on a rewarding career with us.
How to Apply
To apply for this Project Manager vacancy, please send your CV and a Covering Letter to jobs@europlaz.co.uk.
STRICTLY NO AGENCIES PLEASE.
