The Resonetics New Product Introduction (NPI) Engineering Manager is a key member of the site management team ensuring Resonetics’ ability to develop cutting edge medical device products and manufacturing capabilities from early-stage design through successful market introduction and launch. Overseeing all aspects of NPI Engineering and associated manufacturing transfers, this role coordinates closely with the Development and Quality Engineering teams to define and document device manufacturing requirements and processes as devices move through the development lifecycle. Throughout manufacturing process development, the NPI Engineering Manager provides technical oversight, analyzing personnel and equipment requirements while guiding the design of production line layouts for optimal workflow based on customer requirements, projected volumes, and device complexity. As a supervisory resource, the NPI Engineering Manager is expected to help establish best practices, identify, and implement necessary training for the NPI team, and resolve complex technical and business challenges using formal engineering rigor and data driven decisions.
Additionally, this role is involved in long-term planning for personnel, facilities, and equipment / CAPEX needs and management of associated special projects (i.e., facilities expansion) as well as guiding the process for selection, vetting, and coordination of external supply chain.
The individual should be experienced in the full product development lifecycle including project scoping and budget definition, design for assembly and manufacturability, detailed schedule tracking and task management, manufacturing process development and documentation, as well as planning and execution of controlled builds up to and including clinical and pilot line production volumes.
The individual must work closely with internal personnel and cross functional departments, intercompany sites, and interact with consultants, clients, suppliers, and other external company personnel to communicate and implement company objectives in accordance with the QMS and ensure compliance with applicable standards and regulations.
This individual will also play a key role in mentoring less experienced employees.
- Hire, train, and manage personnel to support NPI functions.
- Provide directly, or through subordinates, active NPI Engineering participation on project teams during the development process (e.g., product specifications, development of risk management documents, V&V test protocols and reports, component and assembly specifications, manufacturing process instructions, device manufacturing records, etc.).
- Develop templates and establish best practices for manufacturing process documentation, tooling, and fixture development that result in sufficient capacity to meet customer demand while also promoting product quality, process efficiency, and operator safety in accordance with Resonetics’ established Quality Management System.
- Guide NPI team in production line refinement initiatives, including, but not limited to, implementing process improvements, troubleshooting equipment, and addressing operator inquiries.
- Establish and lead LEAN, Six Sigma, DMAIC and other process improvement initiatives as appropriate for day-to-day problem solving and continuous improvement.
- Oversee process and equipment validation practices (IQ/OQ/PQ/MVP/TMV), as well as associated risk management activities (PFMEA/Risk Assessment).
- Drive utilization of process improvement techniques to solve technical problems and make scale-appropriate equipment and process recommendations.
- Review and approve engineering reports, summarize critical program results to management team, customer, and leadership audiences.
- Complete and manage Capital Equipment Requests and associated infrastructure planning.
- Ensure that accurate and complete QMS records are generated, properly secured, and that they meet regulatory requirements.
- Maintain a professional, credible image with consultants, suppliers, and co-workers.
- Perform other duties as assigned.
- Demonstrate the ability to get things done individually and through others by delegating, influencing, and monitoring to bring work to completion. Inspire confidence, respect, and enthusiasm.
- Customer Focus
- Provide professional, reliable, and prompt service to internal and external customers. Work in partnership with others to meet and exceed customer expectations. Interpret customers’ needs and take appropriate action. Follow through on customers’ inquiries in a professional and timely manner. Identify and communicate the most prudent path forward for the customer given the business goals of the customer.
- Management of Resources
- Be well organized and use time efficiently. Prioritize tasks effectively. Demonstrate initiative and innovation in the use of available resources.
- Communication Skills
- Assure that all verbal and written communications are concise, technically accurate, timely, and professional. Demonstrate strong verbal presentation and negotiation skills. Make presentations in a positive and professional manner. Express ideas, recommendations, and solutions clearly, logically, and concisely in both written and verbal communications. Demonstrate tact and diplomacy in communications. Demonstrate active listening skills and ability to resolve discrepancies with customers.
- Team Building
- Resolve conflict with others in an effective, positive, and mature manner while maintaining a constructive tone. Work well with others to meet goals.
- Remain flexible and resilient. Respond positively to changing priorities. Accept new techniques and procedures quickly and employ them into daily job functions. Effectively handle special assignments outside of daily functions.
- Business & Systems Knowledge
- Demonstrate knowledge of raw materials, production processes, quality control and appropriate use of equipment. Utilize systems to complete assigned tasks. Identify opportunities to change processes or use technology to improve efficiency.
- PREFERRD EDUCATIONBS Mechanical Engineering (or related discipline) preferred
- PREFERRED EXPERIENCE
- Minimum of ten years related experience, preferably in the medical device field
- Comprehensive knowledge of and intimate familiarity with the requirements of current versions of ISO 13485, ISO 14971 and FDA QSR
- Startup company and/or contract services experience
- Experience managing NPI functions within a device or drug manufacturing environment
- At least three years management/supervisory experience
If qualified, apply now. Job title and job location must be included in the application.
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Limitations and Disclaimer: The above job description is meant to describe the general nature and level of work being performed; it is not intended to be construed as an exhaustive list of all responsibilities, duties and skills required for the position. Requirements are representative of minimum levels of knowledge, skills and/or abilities. To perform this job successfully, the employee must possess the abilities or aptitudes to perform each duty proficiently.