**Job Summary**
A high-performing individual to provide hands-on leadership to the Finished Device Solutions (D&D;) team, and to be a key individual in the areas of Quality Management. Medical device development and manufacture experience is essential. Injection molding experience is also a strong plus. The individual will possess a broad range of medical device quality skills and experience, a record of leading and participating with teams from product concept through validation and into manufacturing, as well as in-depth knowledge in several clinical and product areas. This individual will also play a key role in mentoring less experienced employees and must be self-motivated and excited by the prospect of working in a dynamic, entrepreneurial environment.
**Essential Job Duties and Responsibilities**
**Qualifications**
- An experienced individual to provide hands-on leadership for the Manufacturing (D&D;) team, who will champion the Nordson MEDICAL New Product Introduction (NPI) Process.
- A committed individual with working knowledge of Medical Device Manufacturing and a proven track record of scaling processes and systems to meet business growth needs.
- A professional with expertise in Regulatory Compliance knowledge for the applicable regulatory requirements to support our customers for the Design Control and Manufacturing activities.
- This individual will work closely with the Operations and Engineering team leadership to drive and grow the business to meet the strategic objectives of the organization.
- This person will possess the strategic skillset to develop the plans and structure to ensure successful growth without compromising regulatory compliance or quality standards.
**Responsibilities**
- Has the ability to discern an appropriate course of action based upon multiple proposed solutions.




- Typically lead large scale and technically complex projects or projects that have an ambiguous scope or project path, while demonstrating strong interpersonal skills that enable substantial cross-functional influence.
- Regularly interact with the customer and have broad knowledge to understand what the customer wants even if requirements and direction are not clear.
- Provide mentorship to engineers and manage teams, setting appropriate goals and giving direction.
- Has decision making skills to select the members of their team.
- Provide strategic project direction and ensure that technologies are up-to-date and identify technical gaps and takes action to address them.
- Their work is performed without appreciable direction and they exercise considerable latitude in determining technical objectives of their assignments that they complete or delegate to their team.
**Job Duties**
- Provides technical support to Manufacturing and Product Engineering regarding validations, test method validations, and statistical analysis.
- Supports the planning, development, implementation and maintenance of manufacturing methods, processes, and operations for new and existing products as well as the design and manufacturing of new tooling and equipment.
- Supports the Value Stream Model for coordinating activities, including Continuous Improvement projects and management of Quality tasks.
- May conduct evaluation,



approval and performance monitoring of suppliers.
- Ensures the identification, segregation, and disposition of nonconforming material and processes have been established for the facility.
- Provides sustaining Engineering support to resolve manufacturing issues in the plant and with the customer.
- Participate in/lead lean and cost reduction activities.
- Leads & conducts investigations and associated actions related to CAPA and Internal/external audit activities.
- Ensures that investigations and associated actions related to customer complaints are executed in accordance with procedures.
- Performs Internal audits as needed.
- May execute/host external audits.
- Maintains Quality System implementation with procedure and form maintenance and development.
- Ensures that all direct reports are efficiently utilized and billable at target levels.
- Participates in the organization and execution of interdepartmental activities to ensure the completion of projects on schedule and within budget constraints.
- Interacts with customer and supplier companies in a professional manner; proactively communicates with them to ensure an ongoing two-way exchange of information.
- Writes and/or reviews proposals for prospective projects. Ensures all proposals are professionally done and contain accurate technical content, costs, and time estimates.
- Ensures that all work satisfies the requirements of the company's Quality Manual, with emphasis on Manufacturing Controls.
**Education and Experience Requirements**
- Degree in Engineering
- Experience in medical device is essential, minimum ten (10) years, quality leadership desirable
- Experience in Operations / Manufacturing of Medical Devices preferred
- Experience with

📌 Manager, Regulatory Affairs and Compliance (Tecate)
🏢 Nordson
📍 Tecate