2 Program Managers, Medical Device (Senior and Mid-Level)
R&D and Sustaining, direct hire
Onsite, Chicago northern suburbs
These positions are responsible for leading and influencing an established cross functional team through one or more medical device development programs from concept through commercial launch.
Responsibilities for Sr Program Manager
- Provide Program and Technical leadership for complex device development.
- Identify resources needs, costs, program schedule, key milestones, scope, and report the progress to the established plan.
- Maintain and document development plans through product development cycle.
- Establish DHF (Design History File) deliverable schedule with key stakeholders.
- Comply with design control process and meet Quality Management System requirements.
- Communicate with external vendors to set expectations, track risks, and ensure timely delivery to meet program goals.
- Lead teams to process improvements to enable effective decisions and outcomes.
- Manage program budget: functional expenses, capital requests, and forecasts.
- Prepare and report program technical performance to different levels of organization including senior leadership.
Skills & Qualifications for Sr Program Manager
- Demonstrated expertise in leading and managing cross-functional multi-site teams to achieve program objectives in a matrix organization.
- 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-starter with good interpersonal and communication skills to break down complex issues and process into simplified and practical terms.
- Experience in using agile methodologies.
- Advanced knowledge and hands-on experience with MS Office, MS Teams, MS Project, SharePoint, JIRA, and Confluence.
Requirements for Sr. Program Manager
- Bachelor’s degree in in Engineering, Biological Sciences, Business or related fields from an accredited college or university is required
- 5+ years of experience in product development leading multi-site global programs in the Medical Device Industry or with equivalent design controls (closer to 10 yrs. for Sr. PM)
- Electro-mechanical experience, including software integration is preferred.
- PMP preferred
- Agile Certified Practitioner (ACP) a Plus