Senior Manager - Medical Device - Beeline ID:8026-1

Manage an on-shore / offshore team of HW, SW and Systems Engineers to design, build and sustain new electronic based medical device systems across their entire lifecycle.
Gather, collate, and complete information on various processes/products/projects with the SE Project group
Create work packets based on the information and assign to offshore team for execution
Coordinate with various technical professional and functional leads at Client to understand the work requirements and associated deliverables
Act as a liaison between offshore team and Client to resolve queries, knowledge transfer and facilitate communication between the sides
Create and manage the project plans for the projects being handled
Complete all tasks and deliverables directly assigned by Client
Manage resource loading
Perform final quality check of the deliverables, on need basis
Follow Client's Quality management system procedures in executing projects for existing product line extensions and change control.
Follow Client's Control Management Procedure for identification and implementation of changes.
Create and/or update products specifications including component, sub-assembly and/or finished goods specifications in EtQ. This includes redlining of specification sheets, drawings and related documentation as well as managing the contents in EtQ shell.
Support for all product change management projects for example, Quality non-conformance, line extensions, product redesign for feature enhancements and value engineering etc.
Carry out Change Management activities in EtQ
Access applicable modules within EtQ and C-Prfor relevant information pertaining to ongoing projects
Provide support in completing the tasks across functions (not limited to R&D, Quality, etc.) associated with implementation of a given Change Request.
Create and manage Project Plan wherever applicable.
Create Bill of Materials in SAP
Update or Create Instructions for Use (IFU)
Create Component, Sub-Assembly and/or Finished Goods Specifications
Update Device Master Record (DMR)
Migrate Design History Files (DHF) and Design Transfer Matrix (DTM)
Update Work Instructions/Job Aides
Update Technical test method validations
Complete Regulatory Deliverables
Assess/Update Technical File
Complete Unique Device Identification (UDI) assessment
Assess/Update Product Safety Assessment Report
Complete Risk Assessment
Complete Sterilization Assessment
Complete Packaging Assessment
Complete Label Update
Create process handbook in Consultation with Avanos. This document will include the detailed steps and procedures involved in completing specific tasks with the SR process. This process handbook will be updated on regular basis with approvals of Avanos

Master's degree or higher in Engineering or Scientific discipline preferred.

Design for 6 sigma/ Green belt/ Lean/ Agile development Certification

Medical Device experience of successful demonstrated experience in R&D and/or product development or equivalent experience.

Prior experience leading systems, HW or SW engineering teams

Prior experience working in either HW or SW engineering as a core team member delivering new products.

Previous experience in the management of professional staff.

Master's degree or higher in Engineering or Scientific discipline preferred.

Design for 6 sigma/ Green belt/ Lean/ Agile development Certification

Medical Device experience is a strong-plus

Strong understanding of industry best practices and global medical design standards (e.g., ISO-13485, IEC-60601, ISO-14971, IEC-62304, IEC-60812, ISO,62366, cybersecurity, etc.).

Knowledge and experience with not only embedded SW but IoT & cloud-based software tools.

Knowledge of RF and energy-based systems & architecture design

Experience working with JAMA requirement management tool

Demonstration of outstanding written and verbal technical communications skills.

Project management experience is a strong-plus (WBS development, understanding cross-functional linkages, etc.)

A minimum of 10%-20% travel will be required.