Senior Program Manager - R&D at ICU Medical, Inc. in San Clemente, California

Job Description:

Position Summary


The Senior Program Manager for Consumables is responsible for leading projects, with the support of an established Core Team and Program Managers, through the medical device product life cycle of development, qualification, manufacturing, and commercial release process.



Essential Duties & Responsibilities


• Provide Program and Technical leadership for device development.

• Develop, maintain, and document development plans through product development cycle.

• Drive accountability in the position and within the cross functional team.

• Identify resources needs, costs, program schedule, key milestones, scope, and report the progress to the established plan.

• Lead teams to process improvements to enable effective decisions and outcomes.

• Comply with design control process and meet Quality Management System requirements.

• Manage program budget: functional expenses, capital requests, and forecasts.

• Prepare and report program technical performance to different levels of organization including senior leadership.

• Communicate with external partners to meet program goals.

• Provide mentoring and guidance to program and project managers



Knowledge, Skills & Qualifications


• Demonstrated experience in leading and managing cross-functional multi-site teams to achieve program objectives in a matrix organization.

• Ability to lead direct and indirect team members and enabling them to grow.

• Experience in functional areas: Hardware and Software Development, Quality, Medical, Commercial, Manufacturing Operations, Procurement, and Regulatory is preferred.

• Ability to evaluate and escalate changes that significantly impact the scope, timeline, or business goals or the program.

• Familiar with regulatory submissions and activities that lead to successful outcomes.

• Show history of influencing technical teams, driving efficient decision making, and leading team through complex problem solving.

• Use of metrics as indicators of potential roadblocks, risks, and issues which could block successful achievement of the program goals.

• Self-directed with good interpersonal and communication skills to break down complex issues and process into clear actions.

• Experience in using Agile methodologies.

• Advanced knowledge and hands-on experience with MS Office, MS Teams, MS Project, SharePoint, JIRA, and Confluence.



Education and Experience


• Bachelor's degree in in Engineering, Biological Sciences, Business or related fields from an accredited college or university is required

• 10 years of experience in product development leading multi-site global programs

• Experience in the medical device or other regulated industry with equivalent design controls

• Infusion consumables experience is preferred.

• Experience with remediation and MDR activities is preferred

• PMP Certification



Minimum Qualifications


• Must be at least 18 years of age



Travel Requirements


• Typically requires travel less than 5% of the time



Physical Requirements and Work Environment


• This is largely a sedentary role.

• This job operates in a professional office environment and routinely uses standard office equipment.

• While performing the duties of this job, the employee may be required to sit or stand for long periods of time


alary Range- $128,000 - $172,000

The salary range displayed represents the annual base salary we reasonably expect to pay for this role. The actual salary may vary [differ] based upon various factors, including, but not limited to, relevant experience, skills, education, licensure/certifications, and geographic location.


ICU Medical is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.