RampD Engineer Project Manager I

Profile

We are seeking a R&D Engineer Project Manager I for a very important client.

Will work on new product launches outside of the US; work with the Marketing dept to launch products in EU, FDA 510K submissions; not afraid of a lot of work.

Primary Responsibilities:
- The Project Manager is responsible for providing cross-functional project leadership to ensure short term and long term projects achieve desired outcomes from product definition through product commercialization.
- Will help teams define and achieve the objectives and goals required to complete projects on time and within budget. Seeking a strong cross-functional leader with a hands-on approach, with excellent decision making and prioritizing ability.
- Will be responsible for ensuring the successful implementation of best practices in cross functional team leadership.
- Communicates with a variety of stakeholders (regulatory, quality, R&D, manufacturing, system engineering) at all levels effectively
- Develops, tracks and reports key program timelines, risks and mitigations.
- Oversees all phases of the product development process from Concept to Launch, with excellent understanding of Design Control principles.
- Lead complex programs delivering milestones on time and on budget with quality per customer expectations, U.S Food and Drug Administration (FDA) regulations, other regulatory requirements, company policies and all other operating procedures and processes.
- Strong ability to manage resources to deliver program status
- Effectively manage both large and small projects simultaneously
- Maintains positive and cooperative communication and drives for accountability within self and others

Duties: Executes to defined business results expected from a project. Is responsible and accountable for achieving those results; where results are expressed in terms of compliance with Design Control and/or Change Control policies; quality; time; scope and cost. A project is a set of interrelated tasks that culminates in clearly defined business results. For new product development projects; the business results will typically include the launch of one or more products. Differences across the levels of Project Manager are dependent upon increasing project complexity and increasing level of expected independence. Each higher level incorporates the expectations from the lower levels. Manage moderately complex project or several smaller low complexity projects with the assistance from their manager. Evaluates Risk/Reward Trade-offs: Provides risk assessments (both safety and project related) and communicates critical issues impacting product quality to management (Q01 and Q04.01.004)). Establish and maintain risk analysis as part of overall responsibility to control / reduce risk (QO4.01.001) Recognizes strategy; quantifies and evaluates risks; recommends actions and develops contingencies to cope with various scenarios. Able to analyze risk / reward trade-offs and make recommendations of appropriate path forward. Translates Project Goals: Translates project ADD goals into the day-to-day activities necessary to accomplish them.
Requirement:
The ideal candidate will possess the following qualifications:

Years Experience: 1-3 yrs.
Skills: Responsible for implementing and maintaining the effectiveness of the quality system

Education: Bachelor degree in a discipline appropriate to the project environment.

1-5 years of PM experience, or a new grad with solid intern/extern experience in the Engineering or Scientific field.

Preferred Qualification
- Proven track record and demonstrated abilities in project management skills and other related disciplines.
- Excellent verbal and written communication skills.
- Experienced in medical device or FDA cleared product development
- Experience in Quality System Regulations (QSR) 21 CFR 820 and Design Control: ISO 13485:2003

Minimum Education And Experience Required
? Bachelor?s degree in technical field (i.e Sciences, Engineering) or related disciple
? Excellent written and verbal communication skills with ability to succinctly present to senior management
? Ability to travel 20% of the time (when travel is permitted again)
? Proficient with MS Project, Excel and PowerPoint
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