Hello,
-- Role Title: Project Engineer
Location: 22 Cherry Hill Dr, Danvers, MA-01923 [Onsite]
Skills Matrix | ||||
Skill | Last Used | Experience in Years/month | Rating (10 points) 1 = newbie 10 = expert | Hands on Exp. Yes/No |
JAMA | ||||
Medical devices |
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FDA |
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SaaS |
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Agile |
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Job Description:
Key Responsibilities-
- Collaborates with the agile team to translate the business vision into language that can be consumed by development resources.
- Develop and manage the software design history file
- Support Project Documentation and Materials needs via SAP
- Maintain JAMA tool and produce required documentation for the design history file
- Track project performance, specifically to analyze the successful completion of short- and long-term goals
- Meet budgetary objectives and make adjustments to project constraints based on financial analysis
- Develop comprehensive project plans to be shared with management as well as other staff members
- Collaborates with team in identifying workflow and process gaps and issues
- Assists in backlog grooming and maintenance
- Organize and conduct reviews with stakeholders and development teams
- Coordinate cross-functional reporting across teams - ensuring inter-dependencies are documented, understood, and communicated.
- Use and continually develop leadership skills
Job Qualifications-
- Bachelor's Degree in Engineering/Technology
- Self-reliant; takes initiative; results-oriented; collaborative
- Capable of managing time and project assignments with minimal oversight
- Ability to meet tight deadlines in an environment of competing priorities
- Proven commitment to proactive planning, thoroughness, and excellent execution
- Well organized, detail oriented, highly analytical, possess strong problem-solving skills and must have a desire to be accountable for project success
- Excellent team-work and coordination, professionalism and discipline
- Limited travel might be required.
- 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)
- Demonstrates knowledge of quality policies, principles and best practices and FDA/ISO requirements
A strong candidate will also have-
- Experience supporting FDA regulated products
- Project Management Professional (PMP) Certification
- Experience working with Agile development with a Continuous Discovery/Delivery mindset
- Experience delivering SaaS
- Experience working directly with software engineers
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