Find Jobs Find Talent
Sr Project Manager
Rochester, Minnesota  |  Remote
Contract Position
It appears that you have already applied to this job.
Applied on September 29, 2022
Job Id #58819 Posted September 9, 2022


Position Overview

  • The Senior Project Manager (PM) works independently, assuming primary responsibility for planning, directing, coordinating, and delivering project activities through the entire project life cycle (from initiation through handoff to customer) that are major/complex/business critical.
  • The Senior PM is responsible to lead project objectives and completion on time, on budget, and in conformance to project management methodologies and standards.
  • The Senior PM will lead large projects that have site- or enterprise-level strategic importance.
  • Project work has high to very high risk and risk interdependencies, multiple interrelationships, and may have major costs associated.
  • Responsible for managing established budget. Leads and provides direction in the development and tracking of project budgets.
  • Position requires strict adherence to budget management and guidelines of both the assigned department and the institution.
  • Independently leads problem-solving and decision-making activities, within the scope of the project and change management process, taking reasonable and prudent actions to accomplish agreed upon project objectives.
  • Leverages many years of experience to manage extensive projects and is highly competent in the implementation of project results.
  • Uses advanced negotiations skills that are characterized by innovative thinking.
  • The use and application of Agile methodologies is important to this role.
  • Many of the items important to an Agile process are not unique to Agile.
  • This individual may be responsible for monitoring scrum processes and scrum meetings.
  • They may work to increase efficiency, motivate the team, and advocate for changes that will ensure quality and timeliness.

 

 

Skills:

We are seeking a Senior Project Manager to help lead projects in the Software as Medical Device (SaMD) & Regulatory group within the Center for Digital Health.   Please note the very specific project management experience we are seeking for this role:

  • 5+ years of experience of demonstrated project / technical program management / systems engineering experience with complex medical device R&D.
  • Complete understanding and experience with regulated product development life cycle from concept to launch.
  • Working knowledge of FDA Quality regulations related to medical device development and quality and regulatory standards 21 CFR 820, ISO 13485, 14971, 62304, 62366.
  • Understanding of medical device DHF, DMR, and medical device regulatory submission deliverables.
  • Identify stakeholders, understand needs of the customer, and facilitate early identification of potential safety risks for a variety of AI/ML software as medical device products.
  • Experience educating and guiding novice teams through the regulated medical development lifecycle.
  • Well-versed in cross-functional communications through development activities (Planning, Design Inputs/Outputs, Design Verification/Validation, Design Transfer).

Horizontal is proud to be an Equal Opportunity and Affirmative Action Employer. We seek to provide employment opportunities to talented, qualified candidates regardless of race, color, sex/gender including gender identity and/or expression, national origin, religion, sexual orientation, disability, marital status, citizen status, veteran status, or any other protected classification under federal, state or local law.

In addition, Horizontal will provide reasonable accommodations for qualified individuals with disabilities. If you need to request a reasonable accommodation in order to complete the application or interview process, please contact hr@horizontal.com.

All applicants applying must be legally authorized to work in the country of employment.

EQUAL OPPORTUNITY EMPLOYMENT SURVEY

What is your gender?

What is your ethnicity?

What is your Veteran / U.S. Military Status?

Do you identify with one or more of the classifications of protected veterans below?

If yes, please indicate by checking the appropriate box below

Do you have a disability?

You are considered to have a disability if you have a physical or mental impairment or medical condition that substantially limits a major life activity, or if you have a history or record of such an impairment or medical condition.

Horizontal is proud to be an Equal Employment Opportunity/Affirmative Action Employer providing a drug-free workplace.

Success!

You have saved your first job! To see all your Saved Jobs, click here. Or continue scrolling through jobs and bookmark openings that catch your eye and apply for those jobs later.

Return to Job Search
Close

We’re sorry!

There are currently no open positions in your location or accepting applications from out of the country

Return to Home
Close
X
Cookies help us improve your website experience.
By using our website, you agree to our use of cookies.
Confirm