Project Manager

Location: Parsippany, New Jersey
Date Posted: 11-28-2018
Need strong Project Manage who can work closely with business and technology teams.
Run meeting and help establish the work flow of projects. Be able to drive process and procedure though to implementation.
Do not need to have worked out of a Medical company.
They will see people form Telecom, Defense, Networking. Any company that has regulatory process.

Our Client is in need of a strong Project Manager who can work in a very chaotic environment! Someone who can deal with difficult/demanding users. This is a high profile position, and the person will work closely with the President and other “C” level executives.
This position is going to be someone who can handle all of the documents for (Testing, Safety, User Ability, Risk, Agreement process).
Understanding of Application standards such as 60601 or others like this will be very helpful.
This person will be interfacing with the Electronics, Mechanical, R&D and other business groups. This is mostly on the engineering side of the business.
Highly prefer someone from a Medical Device, Pharmaceutical, Biotech market place, BUT will see people from other domains such as Defense, Telecom. They can teach them the Medical domain. Any company that has processes in place and works with detailed documentations for application standards and regulations.
Highly preferred, but not necessary, is having FDA experience.
Highly preferred, but not necessary, is 21 CFR Part 11 or 820 regulations.
 
* Remember this position is someone who can get the company to become Medical device ready.
(official company description)
 
An ideal candidate for our Medical Device Project Manager will be responsible for driving multiple products and projects through the entire life cycle, including 510k submittal. The right individual will need to manage both internal and external expectations, adjust to changing priorities/environments while meeting deadlines, and identify risks within the project. The candidate will need to preform productively under tight timelines, have strong communication skills, and work well in a fast-paced environment.
Job Description:
 Serve as the Project Manager of Canfield’s Medical Device Initiative organizing and coordinating the various activities (both internally and with external consultants as needed) to become Medical Device ready in the USA, EU, Australia, and other territories
 Lead the Medical Device team to define milestones, achieve timeline commitments, and identify risks and issues
 Collaborate with SMEs and Quality Assurance to develop and/or review Medical Device deliverables
 Establish a communication strategy in which to keep all stakeholders and management current on project tasks, their owners, status, roadblocks/issues
 With other stakeholders (external consultants as needed) support the Exact-Transform-Load (ETL) testing efforts associated with applicable standards (60601 and others)
 Develop mechanisms for monitoring project progress and for intervention/problem solving with the team.
 Monitor updates to applicable standards and regulations
 Work with Quality Assurance to ensure project is compliant with regulations
 Prepare and lead management review meetings with agendas, minutes, and action items while facilitating risk management of projects and escalation/mitigation of significant deviations
 
Core Requirements:
 Bachelor of Science degree in engineering or equivalent and at least 5 years’ of experience as a project manager
 Strong leadership, project management, organizational skills
 Knowledge of 21 CFR Part 820, ISO 13485, ISO 14971, IEC 62304 and other international standards and country/region-specific medical directives as well as FDA applicable regulations
 Experience in 21 CFR Part 11 regulated software
 
Desired:
 Background in quality, mechanical, or electrical engineering
 
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