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Process Development Engineer

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  • Job
    Full-time
    Junior & Mid Level
  • Dublin

Requirements

  • Degree Qualified in Engineering or Science related discipline
  • Excellent client-facing skills
  • People management skills - introducing and building ways in which people can learn from each other, encouraging mentoring and the transfer of knowledge by designing and delivering learning interventions
  • Team work and emotional intelligence
  • Good self-management – continuous performance is both an objective and a mind-set
  • Has an innovative approach – a bold thinker and doer, matching creativity with vigilance
  • 1-3 years Engineering experience in Medical Device industry or other regulated industry
  • Knowledge of medical device quality & regulatory systems and medical device directive (EN ISO13485 and FDA CFR 820). Knowledge of Stage-Gate process and/or Product Development life cycle.

Responsibilities

  • Provide support to the project teams in the process development, transfer, validations and subsequent commercialisation of products during the product lifecycle
  • Set up new manufacturing equipment/production lines and assist with staff training, as required.
  • Apply new technologies and methodologies to optimise process design & performance.
  • Work with external vendors to specify, develop and commission new process technologies.
  • Liaise with Business Development, R&D, Manufacturing & Quality to ensure that the transition of products through R&D product approval and manufacturing scale up are smooth, timely and cost effective.
  • Design/source equipment and tooling required to meet both the capability & capacity requirements.
  • Execution of process validation activities.
  • Complete equipment validation including URS, FDS, FAT, EIQ, EOQ...
  • Execute work plans & schedules for development activity

FAQs

What is the main role of a Process Development Engineer at Expleo?

The main role is to provide support to project teams in the process development, transfer, validations, and commercialization of medical device products throughout their lifecycle.

What qualifications are required for this position?

Candidates must be degree qualified in an Engineering or Science-related discipline.

What experience is preferred for the Process Development Engineer position?

The ideal candidate should have 1-3 years of engineering experience in the medical device industry or another regulated industry, along with knowledge of medical device quality and regulatory systems.

What essential skills are sought in a candidate for this role?

Essential skills include excellent client-facing abilities, people management skills, teamwork and emotional intelligence, good self-management, and an innovative approach to problem-solving.

Is prior experience with specific regulations required for this job?

Yes, candidates should have knowledge of medical device directives such as EN ISO 13485 and FDA CFR 820, as well as familiarity with the Stage-Gate process and product development lifecycle.

What benefits does Expleo offer to employees in this role?

Expleo offers a competitive salary, a substantial benefits package that includes medical and dental insurance, pension schemes, employee recognition programs, learning and development opportunities, and various wellness initiatives.

Does Expleo support a diverse and inclusive work environment?

Yes, Expleo prides itself on maintaining a diverse and inclusive culture and implements family-friendly policies and enhanced leave options to support work-life balance.

What kind of working environment can employees expect at Expleo?

Employees can expect a collaborative working environment where teamwork and mutual support are emphasized, fostering growth and skill expansion through exciting projects.

Can individuals with impostor syndrome apply for this job?

Yes, Expleo encourages individuals experiencing impostor syndrome to apply and assures that all applications will be considered in line with the company’s values and role competencies.

Will the position involve working with external vendors?

Yes, the Process Development Engineer will work with external vendors to specify, develop, and commission new process technologies.

What are some specific responsibilities of the Process Development Engineer?

Responsibilities include setting up manufacturing equipment, executing process validation activities, sourcing equipment and tooling, and liaising with various departments to ensure smooth project transitions.

Think bold, act reliable

Consulting
Industry
10,001+
Employees
1966
Founded Year

Mission & Purpose

Expleo is a global engineering, technology and consulting service provider that partners with leading organisations to guide them through their business transformation, helping them achieve operational excellence and future-proof their businesses. Expleo benefits from more than 40 years of experience developing complex products, optimising manufacturing processes, and ensuring the quality of information systems. Leveraging its deep sector knowledge and wide-ranging expertise in fields including AI engineering, digitalisation, hyper-automation, cybersecurity and data science, the group’s mission is to fast-track innovation through each step of the value chain. As a responsible and diverse organisation, Expleo is committed to doing business with integrity and working towards a more sustainable and secure society. Expleo boasts an extensive global footprint, powered by 15,000 highly-skilled experts delivering value in 30 countries and generating more than €1 billion in revenue.