Ref No: AM17407
Co. Dublin, Ireland
Principal Engineer - North Dublin.
In this role you act as a leader within the engineering team in providing comprehensive support to production in the manufacturing and continuous development of complex medical device products. This will also include design improvements, technology transfers, assembly processes, test strategy and ongoing customer support. The position will involve leading a team of engineers to lead problem solving, design development and managing production outages. This can include the design and verification of technical solutions to solve problems, enhance products and process capability in the areas of electromechanical, automation, materials, software & fluidics.
You should have excellent skills across various technologies, understand systems, and be a people leader, technical leader and key decision maker. A background in machine design and/or manufacturing engineering and the managing of complex products across different technologies is required. Candidates must have the ability to lead a technical team, troubleshoot deep technical problems to root cause, and operate and drive continuous improvement in the engineering team.
You should be comfortable operating across multiple functions, locations and key stakeholders to deliver complex projects in a seamless fashion.
You will report to the Engineering Manager and will form part of a flexible engineering team covering manufacturing engineering, new product development and product lifecycle engineering. You should be a self-starter, high paced individual, happy working on projects where the solution is not always obvious and which requires out of the box thinking, where ownership needs to be naturally taken and customer focus is central to decision making.
To be successful in this role, you should be confident managing teams while, at the same time, setting goals, budgets and timelines for various technical projects. You must also be capable of working in a complex multi-site, multi-interface environment where communication is critical in order to deliver projects from end to end.
The role in detail:
1) Lead and develop a technical team of engineers, providing key mentorship to ensure projects are delivered achieving all customer requirements and on target, in a high paced, high complexity, detailed environment.
2) Lead and champion full end to end technical ownership for product, process & technical development of medical device products, including DFSS & DFM considerations, in a high complexity and highly regulated technology environment, with a clear focus on accelerating solutions to customers.
3) Lead technical & process support to production for medical devices in a high complexity and highly regulated technology environment.
4) Requires an ability to analyse & lead deep technical problems to root cause with a structured approach and develop solutions across different technologies (materials, moulding, thermal, fluidic, mechanical, electrical, software). Act as a source of technical reference and key decision maker in technology or process area.
5) Develop strategy for implementation of continuous improvement methodologies to increase quality and efficiency of product and process operations. Champion accelerated innovation cycle, increasing the speed at which solutions can be delivered to customers using continuous improvement initiatives, digitalization and always operating smarter while maintaining compliance.
6) A deep technical competency in the area of mechanical / electro-mechanical / fluidic / automation design is required with a proven ability to design parts, assemblies, jigs, fixtures & test equipment. Familiarity in optics, biochemistry and/or statistics an advantage.
7) Delivering projects & tasks to meet business needs at pace using Agile Scrum, approached with a clear customer focus.
8) Participate in new product developments by providing detailed design, DFM & DFSS guidance in alignment with Lean and 6 sigma techniques
9) Define and lead technology transfer initiatives, lead design of product enhancements and validation of design changes.
10) Develop & sustain world class manufacturing and supply chain processes in association with key stakeholders.
11) Responsible for day-to-day leadership of engineering activity ensuring KPI’s are trending positively and proactively, ensuring no missed outputs while delivering CI.
12) Must have excellent people leadership skills to lead a team of Engineers in their work, with direct mentoring to ensuring the development of high-performance teams. Hire, develop and retain a diverse, highly qualified team and provide ongoing two-way dialogue. Set goals which align to customer requirements and manage the execution of goals through coaching and mentoring.
13) Lead the team to design solutions for products and process across different disciplines (mechanical, electronic, electrical, or software).
14) Have excellent knowledge of verification & validation related to design and process changes. Understand boundary and robustness testing to verify electromechanical and software solutions. Have statistics knowledge to understand process control and sampling rationale
15) Manage a complex work scope and provide comprehensive reporting to the business level product teams on key technical initiatives.
16) Manage budgets, CAPEX, OPEX, department and project
17) Manage product and component redesign initiatives in response to obsolescence, enhancement, reliability or design to cost initiatives in a regulated environment.
Interested applicants should have:
Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully in order to build positive relationships and improve business results.
Requires highly developed leadership skills/experience sufficient to assume the responsibilities of this management position, including the ability to map task interdependencies, multi-task, prioritize such tasks, meet deadlines, and develop, monitor and live within budgets as well as the demonstrated ability to forecast major milestones.
Have strong analysis skills with experience of complex technical troubleshooting, excellent communications skills, written and verbal. Experience implementing engineering changes in a highly regulated environment.
Must be able to work in a dynamic, fast-paced manufacturing environment with strong ability to establish technical and professional credibility.
Strong organizational, planning and follow-up skills, with experience in modern world class manufacturing disciplines (lean, six sigma, DOE, JIT) required.
Strong Mechanical/ Electromechanical / systems design skills for both product and manufacturing fixtures
Must be able to manage and resolve conflicting product and project requirements and be a strong team player with ability to collaborate across functional areas.
Knowledge and experience with Good Manufacturing Practices (GMP)/ISO, and mfg. automation.
Advanced verbal and written analytical/problem solving, communication, negotiation, interpersonal and presentation skills are essential.
Hold a Bachelor’s or Master’s degree in a relevant technical discipline (electrical, electronic, mechanical, systems or computer science) with a minimum of 7 years 'relevant experience across different technologies in a manufacturing engineering environment that has experience of Design changes, NPI and technology transfers. Previous experience in medical devices industry would be an advantage.