Ref No: AM17323
Co. Dublin, Ireland
Senior Solutions Engineer - Medical Devices.
This is a permanent role within the engineering team in the manufacturing of medical device equipment. The successful applicant will act as a leader within the engineering team in providing comprehensive support to product / process development, project delivery & production support in the manufacturing and continuous development of complex medical device products.
This will also include technology transfers, assembly processes, test strategy and ongoing customer support. The position will involve delivering key projects as an individual and as part of a team, deep technical solution development, leading problem solving and managing production outages, and can also include leading a team of engineers. This can include the design and verification of technical solutions to solve problems, enhance products and process capability.
The successful candidate must have excellent skills across various technologies, understand systems, hardware, people collaboration & leadership, be a technical leader and key decision maker. A broad background in technical 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 drive continuous improvement in the manufacturing engineering team.
A background in original equipment / machine design & development from a systems perspective, combined with experience operating across the full value chain of a product is an advantage.
You will report to an Engineering Manager, and will form part of a flexible engineering team covering manufacturing engineering, new product development and commercial product engineering. You should have the ability to work cross-functionally in a complex environment and be able to lead cross-functional teams.
1) Provide 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.
2) Provide technical support to production.
3) A deep technical competency in the area of mechanical / electro-mechanical / 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.
4) Driving projects & tasks to meet business needs at pace using Agile Scrum, always approached with a clear customer focus. Participate in new product developments by providing design for manufacture guidance in alignment with Lean and 6 sigma manufacturing techniques
5) Develop & sustain world class manufacturing and supply chain processes in association with key stakeholders.
6) Requires an ability to analyse deep technical problems to root cause with a structured approach and develop solutions across different technologies (materials, mechanical, electrical, software). Act as a source of technical reference and key decision maker in technology or process area.
7) Define and lead technology transfer initiatives, lead design of product enhancements and validation of design changes.
8) Lead the team to design solutions for products and process across different disciplines (mechanical, electronic, electrical, or software). Have the ability to lead cross-functional teams, with direct mentoring to ensure the development of a high-performance team.
9) Have excellent knowledge of verification & validation related to design and process changes. Understand boundary and robustness testing to verify electromechanical and software solutions.
10) Manage a complex work scope and provide comprehensive reporting to the business level product teams on key technical initiatives.
11) Manage project budgets, CAPEX, OPEX, to complete the assigned work scope.
12) Medium level of statistics knowledge to understand process control and sampling rationale.
13) Manage product and component redesign initiatives in response to obsolescence, enhancement, reliability, or design to cost initiatives in a regulated environment.
14) Hire and retain a diverse, highly qualified staff and provide ongoing performance feedback. Set goals which align to department plans and manage the execution of goals through coaching and mentoring.
15) Develop strategy for implementation of continuous improvement methodologies to increase quality and efficiency of product and process operations.
Interested applicants should have:
• Strong leadership skills, with a proven ability to influence cross-functionally.
• A self-starter with 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 technical & leadership skills/experience sufficient to assume the responsibilities of this position, including the ability to map task interdependencies, multi-task, prioritise 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 and ability to hold others accountable. Experience in modern world class manufacturing disciplines (lean, six sigma, DFSS, DOE, DFM) required.
• Strong mechanical/electromechanical/systems design skills in product, process and manufacturing fixtures development.
• 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 manufacturing 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 (mechanical, mechatronics, design, electrical, electronic, systems or computer science) with a minimum of 8 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.