Spec 3, Engineering Program/Project Mgmt
Company: LanceSoft Inc
Location: San Diego
Posted on: January 26, 2023
|
|
Job Description:
Temp position
--- Ideally local to San Diego - Remote acceptable. May be asked to
come into SD office occasionally.
--- Work hours - regular 40hr week
--- Interviews - Initial video interview/screening screen by HM.
Video interview panel for further rounds.
--- 3 must haves on the resumes - Medical Device experience (FDA
preferred), Experience leading large programs, (as a PM),
cross-functional team experience (more than just R&D)
Responsible for working with internal stakeholders 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 *** associates to learn and adopt
these technologies. Bachelor's degree in related field (business,
engineering, or related analytical field). Minimum of 5 years of
project management. 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 MS
Teams/SharePoint).
Job Description
We are a global business within *** 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 *** Medication
Delivery Solutions (MDS). Reporting to the Sr. Manager of PMO, 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:
- Drive the design controls of medical device development programs
through regulatory submission within timeline, quality and
budgetary limits
- Lead and integrate cross-functional teams and manage deliverables
and decision making in a matrix organization
- 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
development stages
- Manage multiple projects while influencing project decisions in
coordination with Marketing, Medical Affairs, R&D, Finance,
Regulatory Affairs, Quality, Manufacturing and Logistics
- Identify and implement solutions to improve tracking, planning
and collaboration
- Ability to gain cooperation of others and effectively facilitates
cross-functional meetings and discussions
- Ensure effective, accurate and timely communication across
functional areas and matrix
- Serve as a primary point of contact for management regarding
progress and goals
- Work with the functional leaders to identify and resolve any team
and individual performance issues
- Bring a broadened business perspective to each project through an
understanding of the inner-workings of Marketing, Quality, R&D,
Finance, Regulatory, Manufacturing, Finance, Medical Affairs, and
Operations
Minimum Qualifications:
- A minimum of a Bachelor's degree
- A minimum of 5 years of Project Management experience
- A minimum of 5+ years related work experience in product
development.
- Demonstrated success in Project Management roles including
Development and Regulatory Submissions, preferably healthcare, or
closely related is a plus
- Experience leading large programs with globally distributed teams
and leadership
- Excellent interpersonal, communication, presentation and
influencing skills
Preferred Qualifications:
- PMP certification
- High volume medical device and/or drug development and project
management within the medical device/pharmaceutical industry, or
reasonable combination of the two
- Strong familiarity with the integration of requirements and
deliverables associated with Design Controls (21CFR820.30) into the
product development process
- Experience managing ambiguity and providing clarity for teams
- Experience working in a highly government-regulated environment
(FDA, MDR).
- Experience leading a cross-functional project team through
regulatory submission and product commercialization
- Demonstrated learning agility of new subject matter
- Demonstrated application of product development and project
management best practices on recent programs
Keywords: LanceSoft Inc, San Diego , Spec 3, Engineering Program/Project Mgmt, Engineering , San Diego, California
Click
here to apply!
|