Join our clients dynamic and innovative team as a Senior Engineer specializing in New Product Introduction. In this role, you'll lead a dedicated group of Engineers and Technicians, driving the successful implementation of large-scale projects. With your expertise, you'll guide our NPI and Product Development (PD) teams, ensuring seamless collaboration across functions and efficient project execution. If you're passionate about problem-solving, project management, and making a significant impact in the medical device industry, we invite you to be a part of our forward-thinking NPI team.
- Lead a dedicated team of Engineers and Technicians in the New Product Introduction Group.
- Provide guidance and mentorship to NPI and PD team members during the implementation of large-scale projects.
- Oversee and coordinate New Part Introduction in collaboration with the Manufacturing Group.
Take charge of executing the following NPI and PD activities:
- Support the implementation of ISO56000, the Innovation Management Standard.
- Manage Cambus-initiated projects within the Freudenberg Medical Group.
- Drive the Design & Development of New Products following the customer's design process.
- Oversee Prototyping and Testing, including concept evaluation and initial Engineering builds.
- Lead Design Verification and Validation, encompassing the creation of test protocols and reports.
- Handle Risk Assessment and Risk Management in accordance with ISO13485 standards.
- Identify the need for new Technologies to enhance product and process robustness.
- Develop Test Methods & Processes using statistical tools like R&R, DOE, and Equivalence Tests.
- Ensure well-defined processes documented in standard work instructions.
- Validate Processes and Perform Verification before products are ready for commercialization.
- Manage and execute assigned projects from concept to commercialization, including budgeting, prioritization, resource management, status updates, stakeholder engagement, and external communication.
- Define the scope and requirements of new technologies necessary to support project implementation.
- Exceptional communication skills with the ability to connect effectively with individuals at all organizational levels.
- Skilled in cross-functional collaboration, interacting seamlessly with various teams across the organization.
- Demonstrates a commitment to high performance and fosters a highly engaged environment within the NPI Team.
- Proficient in Project Management for NPI & PD projects, utilizing methodologies and tools such as PMBOK and Agile PM Methods.
- Proficient in leading Six Sigma problem-solving and process improvement projects of medium to high complexity.
- Proven experience and expertise in Product and Process Validation.
- Preferred qualification of NFQ Level 8 or higher in a Technical Discipline (e.g., Mechanical, Manufacturing, Mechatronics, or Bio-Medical), with a minimum of 5 years of experience in the Medical Device field.
- Highly desirable qualifications include Project Management and/or Six Sigma certification.
- Distinct advantage if experienced in processes such as Grinding, Moulding, EDM, and/or Laser processes.
For further information on this role please contact Danielle Quinn on 086 044 9371 or email@example.com
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