Nissha Medical Technologies is excited to be in search of a Medical Device Engineering Senior Manager to add to our growing team. This position is an engineering-based role under Design and Development. The focus of the job is to provide is leadership through example and to integrate Nissha based technologies into Medical Device product solutions based on the design inputs provided by the customer requirements. These product solutions may be systems that are mechanically, optically, or electromechanically based. The design process utilized shall be following Quality System and standard operating procedures of Nissha Medical Technologies.A person in this role has demonstrated a track record of successfully executing and completing design projects from start to finish. This individual has established a reputation both internally and externally of the ability to deliver output to the customer on time, on budget, and of high quality. This individual demonstrates a desire to contribute in significant ways to the success of the organization by improving productivity, managing personal output while simultaneously mentoring young employees to positively impact the quality and brand of the organization in the marketplace. This individual consistently demonstrates a willingness to go the extra mile by doing whatever is required to ensure the project output meets the customer's expectation and is at the quality level that the customers have come to expect from the Nissha Medical brand. This person demonstrates the ability to manage the customer and the customer's expectations in a way that enhances the customer's relationship with Nissha Medical. This quality is measured by the engineer's ability to maintain positive long-standing relationships despite difficult circumstances, some of which may or may not be in their control or a direct result of their actions. This person also works synchronously with project managers and the design division management. This person is also capable of managing complex business relationships as part of advanced supply chain development. Has a proven track record of working with a diverse scope of manufacturing processes and is able to generalize this know how into novel solutions.This position can reside near any of our US sites with a preference for Buffalo, NY, Nashville, TN, Norwalk, OH, New Richmond WI, Colorado Springs, CO, Wolcott, CTMandatory Job Duties:
- Apply engineering principles and process to novel Nissha technologies resulting in integrated product solutions
- Communicate technical information to the customer and Nissha management through routine reporting and project status reviews
- To work together with various Nissha Divisions, Departments, and Sites to deliver Nissha technologies integrated into customer guided product inputs resulting in commercially viable solutions.
- Follows and executes Design Control in compliance with 21 CFR 820 and MDSAP ISO 13485.
- Develop fundamental Design and Development deliverables in accordance with industry accepted standards for product development.
- Develop and/or managing complex manufacturing processes and supply chain structures
Educational/ Professional Qualifications:
- At a minimum this role requires a bachelor's degree in an Engineering Discipline (preferably Mechanical, Optics, Electrical, Biomedical, or Aeronautical). Master's degree or Higher is preferred.
- 5 to 8 years of Design related experience is required.
Skills/Qualifications:
- Communication Skills, specifically the ability to convey technical information effectively in both verbal and written medium.
- Coordination and leading multiple parties in technical meetings are required including in-person and virtual attendees over multiple countries and cultures is required.
- Excellent problem-solving skills are required for this role.
- Working knowledge of Dimensioning and Tolerancing to ASME Y14.5 is required.
- Has a proven track record of experience in designing disposable multicomponent mechanical/electrical/ optical systems with between 15-50 components
- Working knowledge of Engineering Statistics is required.
- Skill in engineering analysis in specific areas of study including Mechanics of Materials, Strength of Materials, Static Analysis, Dynamics, and Mechanism Analysis is required.
- Advanced understanding of Plastics and Metals including processes for manufacturing these components for the healthcare industry is required.
- Understanding of methods of inspection is required.
- Ability to conceptualize and document creative mechanical solutions to challenging problems are required.
- Participation in pre-clinical studies and potentially attendance to clinical cases may be required.
- Expert level knowledge of 21 CFR 820/ ISO13485 Design Controls
- Proficient knowledge of Process development and Process Validation.