SENIOR R & D ENGINEER, Product Development Manager (MEDICAL DEVICE)


Sr. ENGINEER: R & D MEDICAL DEVICE
Product Development Manager
Applicable new product development work experience (6-12 years) in FDA regulated medical device/pharma environment using stage-gate product development process
Advanced degree (MS or Ph.D.) may be substituted for work experience
Knowledge of metal and plastic injections molding and FEA analysis is a plus
Responsibilities:
lead concept to launch of New Product Development and existing product improvement initiatives.
responsible for development of specifications, managing risks, leading design and V&V activities.
The scope of the work will be of a complex technical nature requiring investigation of new processes and technologies, and application of advanced engineering design methodologies in a FDA regulated environment.
will be responsible for leading and executing technical activities necessary to complete major projects or several small projects.
work in a cross-functional team environment and require supervision and mentoring of junior engineers.
Identifies and analyzes design problems to achieve optimal solutions that satisfy technical requirements using both internal and external technical resources
Formulates new, innovation approaches to solve technical problems on a consistent basis
Uses engineering and quality process improvements that impact the business via use of best industry practices (six sigma design methodologies preferred)
Leads development of product specifications, risk documents and conduct technical and design reviews
Contributes to the creation and maintenance of Design History Files
Insures project deliverables to meet global requirements (Regulatory, Corporate, Notified Body, etc., as required)
Supports and participates during internal and external audits / inspections as needed

Requirements:
BS in Mechanical/Biomedical Engineering
Applicable new product development work experience (6-12 years) in FDA regulated medical device/pharma environment using stage-gate product development process
Advanced degree (MS or Ph.D.) may be substituted for work experience
Knowledge of metal and plastic injections molding and FEA analysis is a plus
Detailed oriented, possesses excellent documentation skills
Experience with building experimental test set-ups to characterize and assess functional performance of medical products
Demonstrated ability to solve complex design and engineering problems with minimal assistance, while drawing inputs from multiple and varied functions (i.e. Manufacturing, Quality, Regulatory, Clinical Development, etc.)
Strong engineering investigative and analytical problem solving skills
Ability to solve for engineering projects with substantial complexity and scope
Proven communication skills and ability to perform within a cross-functional team environment
Possess organization, communication, and interpersonal abilities
BS degree in Mechanical or Biomedical Engineering required.
Masters or Ph.D. degree preferred
Six Sigma Black Belt preferred
IMMEDIATE INTERVIEW!

Senior Product Development Manager, Project Manager: Medical Device

5-10 years of product development and project management experience in a medical device/ pharma environment.
PMP certification through PMI is a plus.
Working knowledge in Microsoft Project.
Prior applicable medical device product development experience.
Working knowledge of ISO and FDA guidelines as they apply to Product Development/Design Control
Responsibilities:
Project Manager will be responsible for delivery and launch of medical devices and services to the market via cross functional project team coordination.
The scope and scale of projects will range from minor functional enhancements to breakthrough products ranging from mechanical to technological in nature.
New innovations may either be developed internally, or in collaboration with external partners and suppliers.
support small to medium size project teams consisting of a representative(s) from R&D, Quality Engineering, Marketing, Regulatory, Purchasing/Supply Chain, Operations, Finance and Manufacturing.
organizing cross functional team activities which include project schedule creation, project meetings, publishing detailed minutes consisting of action items and deliverables, while monitoring progress against the schedule.
monitor team progress, ensuring that required technical interfaces to support the project are included to support the completion of project tasks and meeting project goals.
Partners with Marketing, Clinical Development and Professional services functions to deeply understand the application and end use of family of orthodontic medical devices and services.
Uses this understanding to be the Voice-of-the-Customer/business while interfacing with project teams and external partners
Aligns specific project(s) to the global product development strategy and ensures compliance and divisional level procedures
Assist with project timeline and deliverables from project initiation stage to launch, including participating in cross-functional meetings outside of regularly scheduled meetings where necessary
Plans projects, directs and coordinates the efforts of engineers and non-technical project team members
Manage timelines and responsibilities of select projects
Conducts project meetings and design reviews
Publishes project action items and meeting minutes which track deliverables and open items.
Create and implement metrics and communication to ensure team commitments (scope, project plan, resources) are met and communicated in a timely manner.
Help ensure that products are launched on time and meet established goals and objectives (per project plan) to support goals of the organization
Develops and maintains program plans and communicate program status to management and internal teams
Drives to keep resources on task and on schedule, manage change, understand technical issues and ensure that they get prioritized, highlighted, addressed and resolved in a timely manner
Assist coworkers where possible in project tasks.
Provides regular updates to all Stakeholders on project status and progress being made
Creates and maintains Project File/(DHF).
Insures project deliverables meet global requirements (Regulatory, Corporate, Notified Body, etc., as required).

REQUIREMENTS:
Graduate or undergraduate degree in Biomedical or Mechanical Engineering
5-10 years of product development and project management experience in a medical device/pharma environment.
PMP certification through PMI is a plus.
Working knowledge in Microsoft Project.
Prior applicable medical device product development experience.
Working knowledge of ISO and FDA guidelines as they apply to Product Development/Design Control
Should also possess strong leadership and team building skills, along with excellent organization, communication and interpersonal abilities.
Able to travel for successful completion of projects
BS degree in Engineering (Biomedical or Mechanical) required.
Master's degree preferred
IMMEDIATE INTERVIEW!
PLEASE EMAIL YOUR RESUME IN WORD FORMAT AND CURRENT BASE SALARY REQUIREMENTS ASAP: darrenf AT rtijobs dot com

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