Technical Project Manager - Medical Device (SaMD)

Description:

We are seeking an experienced and highly skilled Technical Project Manager to lead the development and implementation of our Software as a Medical Device (SaMD. As a key member of our cross-functional team, you will be responsible for managing all technical execution aspects of the project, ensuring that the product meets all quality, cyber security, regulatory requirements, and delivering the project within budget and on time.

What you'll be doing

Develop and manage detailed project plans, timelines, dependencies and budgets to ensure successful delivery of the products – with a focus on meeting the committed timelines.

Collaborate with stakeholders to co-create project plans that are comprehensive and ensure that all stakeholders are aligned and accountable throughout the project.

Integrate the technical project plan with the larger program plan working very closely with the program manager.

Lead the technical execution of the project, working closely with the development team to ensure it is accountable for the committed timelines.

Manage risks and issues, ensuring that they are identified, assessed, and mitigated or resolved in a timely and effective manner.

Be a problem solver – go deep into issues, identify root causes, provide solutions and help unblock teams quickly.

Ensure that all project deliverables are of the highest quality and meet all regulatory requirements.

Work closely with stakeholders to ensure that their needs are met and that the project is delivered on time and within budget.

Ensure that all project deliverables are properly documented and archived, and that all knowledge and lessons learned are captured and shared with the team.

Stakeholder Management:

Identify, analyze, and prioritize stakeholder needs and expectations.

Develop and implement effective stakeholder management strategies to ensure that all stakeholders are aligned and informed throughout the project.

Communicate project progress, issues, and risks to stakeholders, ensuring that all stakeholders are informed and aligned throughout the project.

Manage stakeholder expectations and ensure that all stakeholders are satisfied with the project deliverables.

What you'll bring

Bachelor's degree in Computer Science, Engineering, or a related field with 8 years of experience.

At least 4 years of experience in technical project management, preferably in the software as a medical device industry.

Strong understanding of software development life cycles and regulatory requirements for Medical products. Medical Device experience is preferred.

Proven experience in managing cross-functional teams and stakeholders.

Strong analytical and problem-solving skills.

Ability to work in a fast-paced environment and adapt to changing priorities.

Strong attention to detail and ability to ensure that all project deliverables are of the highest quality.

Previous sustaining engineering and project management experience with demonstrated success leading multi-site activities.

Strong product development/quality background having led the development or participated in product development project end to end, i.e. from concept to production launch.

Strong communication skills, enthusiastic, must be dedicated , metric focused, understands incremental delivery and the value of metrics.

PMP or other project management certification preferred.

Experience with Agile project management methodologies.

Experience with software development tools and technologies.

Knowledge of medical device regulations and industry standards preferred.

VIVA USA, Inc. is an IT consulting firm headquartered in Rolling Meadows, IL servicing clients nationwide. We provide services in IT, Telecom, Finance & Accounting, Clerical/Admin and Engineering categories. VIVA USA Inc is an equal opportunity employer and is committed to maintaining a professional working environment that is free from discrimination and unlawful harassment. The Management, contractors, and staff of VIVA USA shall respect others without regard to race, sex, religion, age, color, creed, national or ethnic origin, physical, mental or sensory disability, marital status, sexual orientation, or status as a Vietnam-era or disabled veteran.