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Project Manager - Regulatory

Waltham, Massachusetts
Seeking a Medical Device Project Manager

Get a great job and possibly save a life in the process!
Integrated Computer Solutions (ICS) is a Boston-area software development firm inventing the future by designing and developing game-changing medical, industrial, and consumer devices. We’re working on some of today’s most innovative tech projects built around touch, voice, gesture, facial recognition, and other exciting technologies. Think flying taxis. Self-driving cars. Intuitive scientific software. 

We’re also at the forefront of medical device development. We’re currently working on vital healthcare products and medical devices, such as highly accurate diagnostics and badly needed ventilators to fight against COVID-19, cancer-killing proton radiation systems, lifesaving cardiac devices, and room-pressure systems for use in the OR and burn units. The work here is interesting, fast-paced, and rewarding. 
As we grow our medical device practice, we’re on the lookout for a driven

Medical Device Technical Project Manager to help with the regulatory process, particularly ISO 13486 and ISO 62304. Does this sound like you? Read the job overview and find out.

As Medical Device Technical Project Manager, 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. 

Here is what you can expect to do:
  • 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 teams to manage stakeholder expectations
  • Create Gantt plans in MS Project that 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
Are you up to the challenge? Here is what you need to be considered for this important position. Note: A background in both regulated software development and UX/visual design moves you to the head of the line!
  • 5-7 years of experience managing regulated projects directly supporting ISO 13486, and ISO 62304. Knowledge of other regulated processes, such as FDA 21CFR820 ISO 14971, IEC 62443-cybersecurity, is helpful.
  • Project manager in an IT capacity
  • Project Management Professional (PMP)  certification
  • 2+ years technical Project Management experience, with priority given to medical device or IVD (In Vitro Diagnostic) development 
  • 3+ years of 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 the 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
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, patience, and a sense of humor.

No, you probably don’t know our name, but you’ve likely seen our work. (Red and white beverage machines and big green tractors are in our portfolio). Our cadre of developers, designers, marketing specialists, and business strategists provide product-driven custom software development and UX design for touchscreen, mobile, embedded, and desktop applications. We’re also the largest independent source of Qt expertise in North America. Check us out at www.ics.com and www.bostonux.com.

If you think you’re right for our team, please apply today!

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