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.
We are located in the beautiful Inverness Business Park in Englewood, CO. We offer a generous benefit package (medical, dental, vision, life, LTD, 401(k) as well as PTO, company-paid holidays and much more) all effective first day of employment!
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 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. Often, communication and coordination of activities will extend to Getinge groups at other locations worldwide.
At Getinge, we seek leaders who exhibit our Core Values: Passion, Collaboration, Openness, Ownership, and Excellence. We are looking for individuals with an open attitude, who always puts the end-user and the patient first. With a creative mindset, our leaders can handle challenging problems while embracing the future.
Our collaborative teams are performance-driven, with a focus on delivering high quality products to our customers.
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 plan and create sprints to have teams focused on task 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.
* Lead and support execution of technical and/or cross-functional project work.
* Ensure the timely release of critical deliverables and milestones within the project.
* Commonly, project activities are spread across different Getinge R&D groups worldwide. Effectively coordinating between groups, and accurately linking timelines is required to achieve project requirements.
* Ensure all aspects of the project are compliant to internal procedures.
* Understanding of group dynamics to influence remote and in-person team members.
* Develop and present weekly status reports across the organization.
* Effective communication with project stakeholders, local management, and global management.
* Demonstrate leadership when facing uncertainty.
* Instill confidence through leadership and actions.
* Understand group dynamics and use this knowledge to lead the project.
* Identify, support, and promote new concepts and initiatives related to Project Management within the organization.
* Communicate project status at defined intervals and meetings and escalate any concerns to the Supervisor and associated Management representatives.
* Manage special and/or confidential projects at the discretion of the Director, CTO or President of Surgical Workflows.
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.
* Experience in leading tasks/projects through a structured process, such as waterfall and agile projects.
* Lead and manage technical meetings with cross-functional members.
* Excellent interpersonal, verbal, and written communication skills; strong technical writing skills
* Ability to listen, convey empathy, and provide support.
* Ability to resolve conflict and build team unity.
* Well organized, detail oriented.
* Task oriented and driven to complete assignments on schedule.
* 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.
Preferred Requirements
* Full product life cycle experience from feasibility to commercialization in a FDA regulated industry (End to End) including experience with New Product Introduction (NPI)
* BS in Engineering or scientific discipline (e.g., Systems, Biomedical, Electrical, Chemical or Software Engineering, Chemistry, Microbiology, Biological sciences or equivalent experience
* 5+ years of experience in medical device or other regulated industry
* 2+ years in task or project lead role
Quality Requirements
* Build Quality into all aspects of their work by maintaining compliance to all quality requirements.
* Ensure compliance to all FDA and Worldwide Quality & Compliance regulations (As applicable to the job function).
* Must have the education and experience to understand and comply with U.S. and Worldwide medical device regulations (As applicable to your job function).
* Attend all required Quality & Compliance training at the specified interval.
* Adopt the "Beyond Compliance Quality Culture" in the work environment; always meet and exceed requirements.
Environmental/Safety/Physical Work Conditions
* Responsible for understanding and conforming to the Environmental Policy to ensure that significant environmental aspects that relate to actual or potential impacts with their work are executed to minimized the
effects on the environment.
* Responsible for bringing to the attention of management any potential improvements that could reduce our environmental impact or to report activities that could result in a negative impact to the environment.
* Responsible for understanding and conforming to the Health and Safety Policy to ensure that the significant risks that relate to actual or potential hazards with their work are identified.
* May work extended hours during peak business cycles.
* While performing the duties of this job, the employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 75 pounds.
* Specific vision abilities required by this job include color vision. Possible visual color matching of ink products may be necessary, as well as the moving of ink containers and/or raw material containers.
* While performing the duties of this job, the employee has the potential to be exposed to fumes, airborne particles, toxic or caustic chemicals. The employee is occasionally exposed to moving mechanical parts. The
noise level in the work environment may be loud.
* Position requires work with organic solvents which have potential for vapor exposure although proper protective equipment is provided. Also, there is noise from production areas when exposed and mixers in
milling room. OSHA standards on Safety and PPE are followed.
* Must wear appropriate PPE as required per job. Hearing necessary to receive and reply to outside contacts and employees. Ability to speak clearly in order to communicate with customers, vendors and employees
in person.
* Must be willing to work in both sitting and standing positions for long periods of time, up to 8 hours per shift. Willingness to frequently move to various locations within building.
Supervision/Management Of Others
* No
Internal and External Contacts/Relationships
Frequent interaction with Supervisor/Manager and Senior Management, Engineers, Operations, Quality Assurance, Sourcing, Regulatory Affairs, Clinical and Medical Affairs, Finance, Marketing and Facilities
* Work/mentor less experienced team members and/or peers on the project.
* Work with more experienced team members to understand products.
* Independent discussions/interaction with outside Customers, Vendors, Consulting Firms and Third-party Testing Laboratories
Disclaimer
The above information in this description is intended to describe the general nature and level of work performed. It does not contain nor is it intended to be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job.
Salary range: $102,000 - $128,000
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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.
Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.
Getinge
paid holidays, 401(k)
Mar 13, 2025