Project Manager@San Diego, California
Note:
Looking for experience managing multi-faceted projects through Verification and Regulatory Submission. Not looking for an IT or Finance PM. Prefer candidates that are local, project position. Currently will be a remote position, but if/when the office opens, would transition to in San Diego office.
Description:
Looking for PM to lead product development/remediation projects.
Familiarity with medical device development and sustaining strongly preferred.
Responsible for working with internal customers to scope projects, create work plans, track progress against work schedules, track budget progress and burn rates, keep plans up to date and publish results, create and present management reports on project outcome and status. Responsible for establishing project quality requirements and adhering to our established method of executing and tracking projects. Responsible for maintaining all active project plans in MS Project (or other similar PPM software) and will be responsible for helping BD associates to learn and adopt these technologies.
Bachelor’s degree in related field (business, engineering, or related analytical field). Minimum of 3 years of project management experience.
History of working in a shared service or BPO organization.
Mastery skills in understanding the business, being agile and applying expertise in communication and working with diverse groups of people and skill sets. Mastery of project scheduling skills and use of PPPM software (like MS Project, and Project Server).
Job Description:
We are a global business within BD Medical, dedicated to delivering quality and innovative solutions in Infusion Specialty Disposables. The business is committed to maintaining its accelerated growth through portfolio diversification, differentiated offerings and geographic / market expansions, while maintaining the profitability of the core product lines.
We manage a healthy portfolio of programs ranging from incremental innovation to disruptive & breakthrough opportunities enabling medication delivery solutions. Our project managers have passion for bringing new technical solutions to market to meet serious unmet clinical needs, have strong records of professional achievement, and have the capacity and desire for continuous development and growth.
We strive to provide each individual with opportunities to develop skills, gain and share knowledge, understand and deliver what our customers want and build a rewarding and fulfilling career.
We are recruiting for a highly driven Project Manager with a passion for product development and a proven track record of successfully delivering solutions that meet the customer requirements. The successful candidate has a unique opportunity to join a high-caliber PMO team responsible for the Design and Development of high growth businesses within BD Medication Delivery Solutions (MDS).
Reporting to the Associate Director of Project Management, the Project Manager is responsible for managing multiple projects seeking regulatory approvals within an Infusion Disposable portfolio. Works within the constraints of budget, schedule, and scope, while managing risk, and ensuring adherence to established processes and methodologies.
Responsibilities:
o Drive the development of medical device development programs through regulatory submission within timeline, quality and budgetary limits
o Lead and integrate cross-functional teams and manage deliverables and decision making in a matrix organization
o Lead, manage and direct the development and execution of integrated project plans relevant to the deliverables and ensure alignment across relevant functions and a smooth transition among pipeline stages
o Manage multiple projects while influencing project decisions in coordination with Marketing, Medical Affairs, R&D, Clinical, Regulatory Affairs, Quality, Manufacturing and Logistics
o Identify and implement solutions to improve tracking, planning and collaboration
o Ability to gain cooperation of others and effectively facilitates cross-functional meetings and discussions
o Ensure effective, accurate and timely communication across functional areas and matrix
o Serve as a primary point of contact for management regarding progress and goals
o Work with the functional leaders to identify and resolve any team and individual performance issues
o Bring a broadened business perspective to each project through an understanding of the inner-workings of Marketing, Quality, R&D, Finance, Regulatory, Manufacturing, Clinical, Medical Affairs, and Operations
Minimum Qualifications:
o A minimum of a Bachelor's degree
o A minimum of 3-5 years of Project Management experience
o A minimum of 7+ years related work experience in product development.
o Demonstrated success in Project Management roles including Development and Regulatory Submissions, preferably healthcare, or closely related is a plus
o Experience leading large programs with distributed teams and leadership
o Excellent interpersonal, communication, presentation and influencing skills
Preferred Qualifications:
o PMP certification
o High volume device and/or drug development and project management within the medical device/pharmaceutical industry, or reasonable combination of the two
o Strong familiarity with the integration of requirements and deliverables associated with Design Controls (21CFR820.30) into the product development process
o Experience with short release cycles
o Experience managing ambiguity and providing clarity for teams
o Experience working in a highly government-regulated environment (FDA, MDR).
o Experience leading a cross-functional project team through regulatory submission and product commercialization
o Demonstrated learning agility of new subject matter
o Demonstrated application of product development and project management best practices on recent programs
Thanks & Regards,
Sekhar Kumar
Sr. Technical recruiter
Software Technology, Inc.
Direct: 6094348010
Board: 609 232 8700 X 119