Program Manager Contract

Company DescriptioniotaMotion is dedicated to innovating cochlear implant surgery to surpass human capabilities. Founded by surgeons from the University of Iowa, the company is revolutionizing the field with its first commercial product, the iotaSOFT Insertion System. This advanced system enables slower, more controlled cochlear implant electrode insertions, reducing maximum forces and variability during the procedure to enhance patient outcomes.Position Overview:The Contract Program Manager leads day-to-day execution of the Next Gen multi-workstream program—coordinating Regulatory, Systems/Interfaces/DV&V, Mechanical, SW/FW, DHF, Design Transfer to Production, Clinical Evidence, and Product/Launch. This role owns cadence, cross-functional alignment, documentation discipline, and risk/issue management to ensure predictable delivery, FDA design-control compliance, and high-quality handoffs (e.g., Ready for DHF, Ready for Transfer). This hybrid position operates up to 32 hours per week 24 hours on site in St. Paul, MN. Responsibilities:·      Own program operating rhythm: weekly Core Team stand-up, monthly Steering updates, and routine cross-functional syncs.·      Maintain the integrated schedule, dependencies, critical path, and resource alignment across all eight workstreams.·      Drive risk, issue, and decision management (RAID): surface blockers early, coordinate mitigations, and manage escalations.·      Stand up and govern the Teams/SharePoint/Planner environment: standard buckets, evidence discipline, file hygiene, and version control.·      Ensure design-control documentation flow: shepherd deliverables to ‘Ready for DHF’ with complete evidence and traceability.·      Coordinate phase gates and design reviews; track action items to closure (DR1–DR4, DV&V readiness, transfer readiness).·      Partner with RA/QA on regulatory readiness (Pre‑Sub, SE Table, usability protocols) and submission packaging.·      Coordinate with Operations for Design Transfer (DMR content, supplier onboarding, packaging qualifications, site readiness, pilot builds).·      Roll up workstream status into R/Y/G dashboards and an adoption scorecard (tasks complete, overdue, # Ready for DHF/Transfer).·      Implement and refine Power Automate flows (e.g., Ready for DHF intake, Submissions folder lock/approval, SW Release Candidate broadcast).·      Facilitate cross-team interface alignment (Systems ↔ Mech ↔ SW/FW ↔ Ops/RA/Clinical/Marketing).·      Prepare concise executive communications and decision briefs for Steering Committee. Qualifications:·      Bachelor’s degree in engineering, science, or related field; advanced degree or PMP/PgMP a plus.·      5+ years of program/project management driving complex product development (medical device/regulated preferred).·      Demonstrated success leading multi-workstream programs with hardware + software + operations components.·      Working knowledge of FDA design controls (21 CFR 820.30) and DHF/verification/validation practices.·      Expertise with Microsoft 365: Teams, SharePoint, Planner, OneNote; comfort with Power Automate and dashboards.·      Exceptional communication, stakeholder management, meeting facilitation, and decision framing skills.·      Highly organized and proactive; able to operate on-site 24 hours/week in St. Paul, MN. Remainder of hours remote. Work Conditions & Terms:·      In-office in St. Paul, MN; 24 hours/week (Tue–Thu), remaining hours remote·      10+ month contract with potential extension.·      Occasional travel to Design Center (Pittsburgh PA), suppliers/partners as needed.