Time is money.
And wasted time means wasted money. We hate that. If you do too, you might be just who we are looking for: Mid-level Technical Project Manager – Regulatory
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 is not hyperbole. We are 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 do not know our name -- we keep things hush, hush so our clients can shine -- but you have 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 the 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:
Are you up to the challenge? Here is what you need to be considered for this important
- Act as a liaison between technical staff and a customer’s program 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 the customer or other constraints; establish milestones and a cost basis for the estimate.
- Track project execution relative to baseline, and escalate issues
- 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
- Contribute to the development of PMO assets and processes
- Establish credibility at all levels in the client organization to ensure project continuity and to enhance future business opportunities
If you have checked those boxes, your star will rise if you have these additional qualifications:
- 2+ years technical Project Management experience, with priority given to medical device or IVD (In Vitro Diagnostic) development
- 3+ years Software Development experience using an SDLC (Software Development Life Cycle)
- Familiarity with Agile/Scrum, IDEs, automated build systems, Unit Tests, and defect tracking
- Extensive knowledge of the different types of testing such as White/Black-box, unit, functional, regression, integration, performance, and acceptance
- Strong Communication Skills: This job will require strong situational awareness and with strong listening skills and the ability to concisely convey technical and logistical information in a complex matrixed environment
- Ability to execute project management responsibilities such as weekly status meetings, risk mitigation, working with a project charter, project planning/procurement/budget, cost, tracking/scheduling, weekly status reports, and financial updates
- Experience in new product development, sustaining engineering, or manufacturing
- 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 to get to the root of the issue.
- B.S. in an analytical field, engineering, or related science
- PMI PMP (Project Management Professional) certification
- 5-7 years of direct experience as Project Manager in an IT capacity
- Knowledge of FDA 21CFR820, ISO 13485:2012, ISO 14971, ISO 62304, IEC 62443-cybersecurity
And, of course, we expect you to have excellent 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 are 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 of their toughest and most complex challenges.
If you think you are right for our team, please apply today!