Project Engineer

Skills Matrix
Skill
Last Used
Experience in Years/month
Rating (10 points)
1 = newbie 10 = expert
Hands on Exp.
Yes/No
JAMAMedical devicesFDASaaSAgile
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

• 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

• 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