Senior Manager - Medical Device

Job Title: Senior Manager - Medical Device

Location: Atlanta, GA

Mandatory Skill set - Medical Device experience as R&D engineer

We are now inviting applications for the role of Senior Manager, R&D Medical Devices –. As an expert in regulatory information management, you will have the opportunity to be a part of a passionate group and help our esteemed clients achieve data drive transformation.

Responsibilities

This role is to support a Medical Devices client based in the US. Key responsibilities will include:

• 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

Qualifications we seek in you!

Minimum Qualification

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.

Preferred Qualifications/ Skills

• 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.