Project EngineerOmni Inclusive • Danvers, MA, United States
Project Engineer
Omni Inclusive • Danvers, MA, United States
30+ days ago
Job type
- Full-time
Job descriptionBachelor'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 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
Skills Matrix Skill Last Used Experience in Years / month Rating (10 points)
1 = newbie 10 = expert Hands on Exp.
Yes / No JAM Medical devices FD SaaS gile
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-
A strong candidate will also have-
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Project Engineer • Danvers, MA, United States