Project Manager, R&D - Englewood, CO

Getinge; Denver (CO); Hybrid; USD 102,000 - 128,000; Full time

Job summary

An established industry player is seeking a dedicated Project Manager to lead cross-functional teams in the development of innovative medical devices. This role involves overseeing the full product lifecycle, from feasibility studies to commercialization, ensuring compliance with FDA regulations. The ideal candidate will have experience in Agile methodologies and project management tools, such as Jira and Microsoft Project. Join a passionate team committed to improving healthcare solutions and making a difference in patients' lives. If you thrive in a dynamic environment and are ready to take on challenging projects, this is the opportunity for you.

Qualifications

• 3+ years in medical device or regulated industry experience.
• Full product life cycle experience from feasibility to commercialization.

Responsibilities

• Lead cross-functional teams in managing complex projects.
• Develop project timelines and budget estimates for product development.

Skills

Project Management

Medical Device Development

Agile Methodologies

Communication Skills

Microsoft Project

Jira

Education

Bachelor's Degree in Engineering or related field

Tools

Microsoft Project

Jira

Job description

Project Manager, R&D - Englewood, CO

Date: Mar 13, 2025

Location: Denver, CO, US

Remote Work: 1-2 days

Salary Range: 102,000 - 128,000

With a passion for life

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge, we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers.

Are you looking for an inspiring career? You just found it.

Steritec Products Inc., a member of the Getinge Group, manufactures sterilization and cleaning medical device consumables using ink technology. We manufacture and print highly specialized proprietary inks that undergo specific color changes when exposed to different sterilization conditions in hospital and industrial/pharmaceutical sterilizers.

This Project Manager position is an on-site, full-time, salary-exempt position. Hours are Monday – Friday, 8:00am – 4:30pm (with some flexibility).

Job Purpose
The Project Manager will be responsible for the leadership of complex cross-functional projects related to the development and complete integration of Consumables and systems into the Sterility Assurance Product Portfolio. The Project Manager is also responsible for the full product development lifecycle, including design transfer to operations and commercialization. In these phases, the Project Manager is required to develop project timelines and budget estimates, assemble required project teams, track the schedule, cost/budget and deliverables, and maintain effective communication throughout a matrix organization for the project.

Job Functions
• Lead a cross-functional team in managing and executing projects in support of Class II medical devices.
• Monitor and maintain awareness of new and current product regulations and standards.
• Develop and maintain project plans and create sprints to have teams focused on tasks at hand. Familiarity with Waterfall and Agile product development methodologies is a strong plus.
• Track project progress via multiple methods (Kanban, Action/Decision Log, e.g.)
• Track project expenses relative to project budget.
• Evaluate project management tools and methodologies for the purpose of more effective coordination of resources and project execution.
• Drive meetings via scrum initiation, daily standups and scrum review/retrospective.
• Ensure the timely release of critical deliverables and milestones within the project.
• Communicate project status at defined intervals and meetings and escalate any concerns to the Supervisor and associated Management representatives.

Required Knowledge, Skills and Abilities
• Full Medical device product development life cycle experience. From feasibility to 510K/DE Novo submission. Experience with Microsoft Project or any other project management software.
• Experience with Jira, Agile project management software.
• Excellent interpersonal, verbal, and written communication skills; strong technical writing skills.
• Well organized, detail-oriented, and task-oriented.
• Must have the ability to effectively interface with both technical and non-technical personnel.

Minimum Requirements
• Full product life cycle experience from feasibility to commercialization in a FDA regulated industry (End to End).
• Minimum of 3+ years of experience in medical device or other regulated industry.
• Minimum of 2+ years in task or project lead role.
• Domestic and/or international travel up to 20%.
• This is an onsite, in-person role with occasional flexibility to work remotely, as approved by senior management.

About us
With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.