Overview
Skills
Job Details
Role Title: Project Engineer
Location: 22 Cherry Hill Dr, Danvers, MA-01923 [Onsite]
Job Description:
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Collaborates with the agile team to translate the business vision into language that can be consumed by development resources.
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Develop and manage the software design history file
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Support Project Documentation and Materials needs via SAP
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Maintain JAMA tool and produce required documentation for the design history file
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Track project performance, specifically to analyze the successful completion of short- and long-term goals
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Meet budgetary objectives and make adjustments to project constraints based on financial analysis
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Develop comprehensive project plans to be shared with management as well as other staff members
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Collaborates with team in identifying workflow and process gaps and issues
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Assists in backlog grooming and maintenance
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Organize and conduct reviews with stakeholders and development teams
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Coordinate cross-functional reporting across teams - ensuring inter-dependencies are documented, understood, and communicated.
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Use and continually develop leadership skills
Job Qualifications-
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Bachelor's Degree in Engineering/Technology
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Self-reliant; takes initiative; results-oriented; collaborative
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Capable of managing time and project assignments with minimal oversight
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Ability to meet tight deadlines in an environment of competing priorities
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Proven commitment to proactive planning, thoroughness, and excellent execution
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Well organized, detail oriented, highly analytical, possess strong problem-solving skills and must have a desire to be accountable for project success
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Excellent team-work and coordination, professionalism and discipline
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Limited travel might be required.
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Minimum of 1 year experience in the medical device industry as well as Medical Device Software systems and cardiovascular devices highly preferred (Class III medical device experience strongly preferred)
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Demonstrates knowledge of quality policies, principles and best practices and FDA/ISO requirements
A strong candidate will also have-
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Experience supporting FDA regulated products
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Project Management Professional (PMP) Certification
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Experience working with Agile development with a Continuous Discovery/Delivery mindset
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Experience delivering SaaS
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Experience working directly with software engineers