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). Well organized, detail oriented, highly analytical, possess strong problem-solving skills and must have a desire to be accountable for project success.
Numbers & Facts
Location
Danvers, MA
Industry
Other/Not Classified
Company Size
100 to 499 employees
Description
Skills Matrix
Skill
Last Used
Experience in Years/month
Rating (10 points) 1 = newbie 10 = expert
Hands on Exp. Yes/No
JAMA
Medical devices
FDA
SaaS
Agile
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.
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