Full Job Description
Time is money.
And wasted time means wasted money. We hate that. If you do too, you might be just who we’re looking for: Project Manager – Medical Devices who thrives on delivering every project on time, within budget and scope.
Who are we? Integrated Computer Solutions (ICS) is a Boston-area software development and UX design firm dedicated to inventing the future. This isn’t hyperbole. We’re working on some of the most exciting and innovative tech projects in development today. Think flying taxis. Operating-room control systems. Self-driving cars. Miniature x-rays. Next-gen restaurant equipment. Interactive experiences for scientific labs.
No, you probably don’t not know our name - we keep things hush, hush so our clients can shine - but you’ve likely seen our work. If you’re high energy, calm under pressure, and flexible enough to handle multiple projects at one, you might be perfect for this high-visibility role.
Here’s the scoop.
With this pivotal project management job, you’ll help ICS manage execution of both product-driven assignments featuring a heavy engineering component, as well as experience-driven assignments that encompass a large visual design component.
A background in regulated software development and UX/visual design moves you to the head of the line!
Here’s what you can expect to do:
Act as a liaison between development staff and technical manager
Facilitate/participate in meetings throughout the project lifecycle on topics including project planning, execution, UX, system design, Design Controls, Joint Application Development, and User Acceptance Testing
Work closely with customer and project team to manage stakeholder expectations
Create Gantt plans in MS Project which include the Work Breakdown Structure, task dependencies, work estimates and project milestones for mixed discipline teams
Develop the resource-loaded project schedule in MS Project in accordance with customer or other constraints; establish milestones and a cost basis for estimate.
Track project execution relative to baseline using Earned Value methods and deliver status updates to clients.
Conduct assessments and evaluations of project performance and quality through the independent analysis and interpretation of objective and subjective evidence (including project status reports, quality assurance, and configuration management audit results), and through direct discussion with project team members
Manage the project close-out process
Establish credibility at all levels in the client organization to ensure project continuity and to enhance future business opportunities
Are you up to the challenge? Here’s what you need to be considered for this important
5-10+ years Project Management Experience in a regulated industry (medical, biotech, aerospace) with much of that in a full software development lifecycle environment (SDLC)
Ability to execute project management responsibilities such as weekly status meetings, risk mitigation, working with project charter, project planning/procurement/budget, cost, tracking/scheduling, weekly status reports and financial updates
Ability to effectively communicate & message in a complex, matrixed environment
3+ years of project management
Experience managing a project for a medical device or IVD.
Strong Communication Skills: This job will require strong situational awareness and effective written, verbal and listening communication skills. Project management by influence.
Knowledge of product lifecycle management methodologies and tools
Experience working in a matrix organization.
Experience managing financial and budgetary aspects of programs, including business case and portfolio management required
Experience Project Managing large projects (budgets in excess of $10m)
Flexibility to handle demands of a rapidly growing and changing workplace
Adequate discipline and professionalism to work diligently within published FDA device regulatory guidelines and rigorously follow internal Standard Operating Procedures.
Naturally inquisitive – the successful project manager will ask “Why?” often in order to get to the root of the issue.
B.S. in analytical field, engineering or related science
Knowledge of the following: FDA 21CFR820, ISO 13485:2012, ISO 14971, ISO 62304, IEC 62443-cybersecurity
Experience in new product development, manufacturing and/or supply chain function
Extensive knowledge of the different types of testing such as White/Black-box, unit, functional, regression, integration, performance and acceptance
If you’ve checked those boxes, your star will rise if you have these additional qualifications:
PMI PMP (Project Management Professional) certification
5-7 years direct experience as Project Manager in an IT capacity
And, of course we expect you to have strong communication skills (you need to be comfortable interfacing with customers on a regular basis), the ability to adapt to and successfully lead an existing team, and a sense of humor.
Our cadre of developers, designers, and marketing and business pros provide product-driven custom software development and UX design for touchscreen, mobile, embedded and desktop applications. We’re the largest independent source of Qt expertise in North America. Our customers include some of the world’s most recognized brands - organizations used to working with the best of the best. They look to us for new solutions to some off their toughest and most complex challenges.
If you think you’re right for our team, please apply today!