Senior NPI Engineer

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.

Key Responsibilities:

• 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.

Qualifications:

• 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 engineering@hero.ie 

Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/

Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.

Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given.  You have supplied us with your personal data in the process of applying for a position.  Our client company may have personnel outside of the EEA who will review you data.  We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.