INSTALLED BASE CHANGE IMPLEMENTATION LEAD - HW AND SW FIELD SERVICE ENGINEERING & PRODUCT DESIGN CHANGES - SURGICAL ROBOTICS
This is a special role requiring someone with a blend of skills and experience. It is essential that you have worked in Medical Devices. This position needs to be onsite in San Francisco Bay.
This role is responsible for managing all aspects of Engineering Change/Product Design Change Implementation to the Robotics System in Manufacturing and in the Field.
You will manage complex change implementation tasks that require detailed analysis and evaluation of data to enable a smooth cut-in and roll-out of changes to the product. An essential part of the role is ensuring alignment across various parts of the organization and drive projects from change initiation through change implementation.
Changes will include hardware and software changes. You will work closely with the NPI Engineering and Sustaining Engineering teams as well as the Supply Chain Manager, Inventory Control and Field Service Teams.
You need to identify the ideal 'cut in' time to make the appropriate system -hardware or software changes balancing the inventory, WIP, wastage, availability and location of Field Service Engineers making trade offs between ;
- minimising service disruption to the hospitals - peak hours / weekend / overnight- accomodating alongside planned maintenance visits where possible unless mandatory changes
- inventory management - WIP, part assembly , raw materials , wastage.
Responsibilities
Day-to-day activities include
- Acting as the interface between Operations, Supply Chain, R&D (including Sustaining/Continuing Engineering) and Customer Support organizations to coordinate the planning, roll-out and timely implementation of Product Design and Engineering changes.
- Developing and documenting the Change Implementation process in collaboration with related departments, including Quality functions.
- Driving and facilitating Change Coordination activities that are required during pre- and post-change implementation, including documentation and maintenance of records associated with the process. In addition, and as required: Establishing a cross-functional review meeting for Change Implementation Coordination, creating the agenda and facilitating the review and decision-making process.
- Analyzing existing processes for effectiveness and inefficiencies, and making improvements as needed.
Qualification, Skills & Attributes
In addition to bringing the required soft skills as a solution-oriented team player in a fast-paced start-up environment, this job requires solid experience in managing the implementation and the deployment of Engineering Changes/Product Changes to Manufacturing and Field/Service organizations.
Must-haves for a successful contribution:
- Experience in Engineering Change implementation, including solid understanding of change implementation impact to Materials Planning, Manufacturing, Field/Service Customer-installed product and systems.
- Strong technical background
- Experience in the medical device industry (US FDA, international medical device regulations, ISO 13485 quality system requirements)
- Strong understanding of healthcare capital equipment
- Demonstrated Project Management experience
- New Product Introduction experience preferred
- Exceptional cross-functional collaboration, structured, effective and clear communication skills
- Attention to detail and used to provide clearly structured documentation
- Experience with documentation requirements in regulated industries, ideally Medical Device
- Proficiency in various software and applications such as Slack, Notion, Teams, etc.
- On-Site / Office presence
Position Reports To: Operations Organization - Sustaining/Continuing Engineering
