V&V Engineer defining verification and validation strategies, ensuring project compliance and safety in engineering domains. Collaborating with cross - functional teams and meeting complex regulatory standards.
About the role
- Engineer developing new medical technologies at Teleflex, improving patient health through innovation. Collaborating with teams, managing projects, and ensuring compliance with regulations.
Responsibilities
- Responsible for developing concepts for new technologies, prototyping to test and validate the concepts and develop full scale solutions for customer offering.
- Responsible for identifying, developing, and implementing innovative technical solution to drive organizational growth and efficiency.
- Develop and improve platforms for the services of new technologies introductions.
- Collaborate with internal customers such as production value streams and project teams to understand their technology requirements.
- Provide input and guidance into potential fixturing and semi automation of processes as requested in a collaborative manner that takes account of Value Stream quality and reliability risk concerns.
- Communication and collaboration with internal customers to ensure new technology requirements meet their needs throughout the project lifecycle.
- Gain consensus from internal customers on new technology solutions prior to implementation.
- Standardise, Reuse, combine or redefine existing technologies to create low risk and fast turn technical solutions.
- Collaborate in the development of new technology platforms which will have site wide and OEM wide impact.
- Research emerging trends and conduct market scans to identify new hardware or software that aligns with the company’s technology roadmap.
- Create concepts, develop small-scale test setups, and perform feasibility trials to validate new processes before full-scale deployment.
- Ensure all new technologies meet regulatory standards (e.g., ISO13485, GDPR, FDA, GMP for medical devices) and relevant EHS safety protocols within the OEM group.
- Evaluate technical offers from vendors and manage third-party providers involved in innovation and development to align New Technology Strategy goals.
- Coach, develop and motivate staff in the development of next generation of new technologies.
- Actively participate in cross functional teams and value stream initiatives to meet new technology company goals.
- Represent the new technology group in customer interactions including customer visits in a professional, constructive and commercially aware manner.
- Collaborate in the new technology assessment tool in collaboration with the Value Streams to assist in identifying and scoring processes and process steps that are good candidates for future processes in the OEM environment.
- In conjunction with the value stream Engineering Managers, establish and maintain high technical standards.
- Lead by example in ensuring that all elements of projects and process improvements are delivered to a high standard within the Engineering team – this includes documentation, reviews, testing, change-review, training, etc.
- Provide expert input into quotation of new technology opportunities and proposals from a technology perspective.
- Collaborate with colleagues to identify efficient low technical risk approaches that are designed with process validation in mind.
- Delegate and coordinate work within areas of ownership. Measure and manage team performance as required.
- Lead, motivate and/or participate in cross functional teams.
- Takes ownership for area of responsibility. This can be interpreted as taking a proactive approach to improvement and anticipating, recognizing, and dealing with problems before they become major issues.
Requirements
- Third level relevant Degree.
- 5+ years’ technical experience in a similar environment.
- Machine Design experience would be an advantage.
- Basic Project management skills.
- Background in Mechanical/Electrical Engineering would be desirable.
- Understanding of Medical Device Quality system.
- Statistical analysis.
- Structured Problem-Solving techniques.
- Understanding of Lean Principles.
- Ability to drive projects to completion.
- Technical report writing.
- Process validations/FMEA's and protocols.
- Understanding of Health & Safety - Machine safety, basic Ergonomics, electrical safety, Chemical safety.
- Ability to generate and understanding technical drawing (AutoCAD/Solidworks).
- Understanding of new product introduction process.
- Ability to influence employees that do not report directly.
Benefits
- Health insurance
- 401(k) matching
- Flexible work hours
- Paid time off
- Professional development opportunities
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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