Project Engineer
Cork
Contract
GxP Recruitment are delighted to be supporting our Global Healthcare Client as they look to add a Global Project Engineer to their team. As a Global Project Engineer, you will be responsible to:
Lead and/or support complex design transfer and optimization project for best-in-class, fully automated manufacturing lines within Third-Party Manufacturers as required. The successful applicant will be responsible for supporting the entire lifecycle of new equipment and major modifications to existing footprint from design review through to production ramp up.
You should also have the following skills:
Lead and/or support complex design transfer and optimization project for best-in-class, fully automated manufacturing lines within Third-Party Manufacturers as required. The successful applicant will be responsible for supporting the entire lifecycle of new equipment and major modifications to existing footprint from design review through to production ramp up.
- Plan, implement and manage major engineering projects associated with assembly of finished product including development, build, test, commissioning, validation activities, RCE documentation etc. as required.
- Drive activities at the equipment supplier(s) to ensure that production start-up through to scale up to increased volumes are achieved per requirements.
- Lead and participates in design, planning, introduction, and sustaining of automated manufacturing lines.
- Ensure the project meets quality requirements of all key internal stakeholders including but not limited to internal R&D, Regulatory, Quality groups while also being the key contact for TPM operations to ensuring adherence to the required policies and procedures. Measures and reports progress against approved timelines.
- Ensure prompt attention of Senior Management in areas of risk, which might have an adverse effect project delivery, product and/or safety.
- Acts as an effective project leader in supporting timelines, quality disciplines, decisions, and practices.
- Interface with product team members, department managers, designers/equipment manufacturers, R&D, Quality, and Regulatory personnel.
- Represent department/division on projects.
- Show initiative in developing and promoting implementation of innovative ideas or potential solutions and champions change without prompting. Controls and implements any relevant engineering changes.
- Independently conceive and develop problem solving approaches which require application of advanced technical knowledge - applies working knowledge of related disciplines.
- Independently designs and leads complex engineering studies and experiments often with multiple variables. Analyses complex problems and identifies their impact using statistical analysis of measurement results. Sets complex design and process requirements.
- Responsible for completing documentation in a timely manner and in accordance with business standards.
- Initial project related travel is to be expected – approximately 20-30% with potential for short periods of up to 50% during key project phases. Europe (primarily).
You should also have the following skills:
- Capability of creating process documentation and technical procedures associated with medical device processes & equipment.
- Capability of reviewing equipment design and conferring with scientific, engineering, and technical personnel to select suitable measurement methods and resolve hardware and software problems (such as product or system malfunctions, incomplete test data, data interpretation or coding issues).
- Analytical skills required to perform root cause analysis, develop and coordinate corrective action measures, and define monitoring improvements for issues affecting yield and cycle time problems.
- Capable of analysing and interpreting process characterization data and prepares technical reports for use by engineering and management personnel.
- Strong interpersonal skills for liaising between vendors, suppliers, Third Party Manufacturers, host-site personnel, management, and colleagues.
- A relevant Level 8 Degree in Engineering/Manufacturing or equivalent with 5+ years progressive technical experience and demonstrated competence. Automation / Electronics / Mechatronics degree preferred. (Master’s degree preferred)
- Ability to work within a team and as an individual contributor in a fast-paced, changing environment. Ability to leverage and/or engage others to accomplish projects.
- Strong verbal and written communication skills with ability to effectively communicate at multiple levels in the organization.
- Ability to Multitask, prioritize, and meet deadlines in timely manner.
- Strong organizational and follow-up skills, as well as attention to detail.
- The immediate reporting line will be to offsite remote manager, with onsite team-based support. The individual will be required to be self-starting and self-motivated.