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