Project Manager (Engineering/Lifesciences/Medical Design controls) Location - Bothell, WA, (Onsite) Position type – Open for both FTE or contract. Visa – USC / GC Key skills: Program Management, Project Planning, Milestone Management, Scope Control, Governance, Change Control, Risk Management, Resource Capacity Planning, Backlog Readiness, Delivery KPIs, Medical Device Design Controls, DHF Remediation, Quality, Regulatory, Supplier Quality, PMS, Audit Readiness, FMEA, V&V Documentation, Onsite-Offshore Delivery Models, Fixed-Price Programs, Milestone-Based Delivery, Outcome-Based Programs, Definition of Done, RAID Management Role and Responsibilities: Manage Project as Cyient’s onsite single point of contact for program management, functional leads, SMEs, and Steering Committee members. Develop and maintain integrated work-package, milestone, resource, and product-wave plans aligned with the customer-owned Integrated Master Schedule. Manage scope, priorities, dependencies, deliverables, acceptance criteria, and Definition of Done across multidisciplinary workstreams. Maintain Smartsheet dashboards, milestone trackers, RAID registers, decision logs, action trackers, and completion forecasts. Lead daily coordination, weekly status reviews, monthly governance meetings, and executive-level reporting. Proactively identify and escalate risks involving documentation, system access, SME reviews, supplier evidence, V&V records, resources, and schedule. Coordinate cross-functional reviews, comment resolution, controlled-document release, milestone acceptance, and product closure. Monitor delivery KPIs, including on-time delivery, first-pass acceptance, traceability completion, review turnaround, and action closure. Manage onsite-offshore coordination, resource capacity, backlog readiness, knowledge transfer, change control, and customer communication. Education & Experience: Bachelor’s degree in Engineering, Life Sciences, or a related discipline. At least 12 years of project or program management experience, including experience in medical devices or another regulated industry. Proven experience managing customer-facing onsite and offshore delivery models. Experience of delivering fixed-price, milestone-based, or outcome-based programs. Experience leading multidisciplinary engineering, Quality, Regulatory, Supplier Quality, PMS, and documentation teams. Strong knowledge of project planning, milestone management, governance, RAID management, scope control, and executive reporting. Understanding of medical-device design controls, DHF remediation, risk management, FMEAs, V&V documentation, and audit readiness. Working knowledge of ISO 13485, ISO 14971, FDA quality-system requirements, and EU MDR principles. Strong stakeholder management, facilitation, negotiation, communication, and problem-solving skills.
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Reference: 631304Posted: 2026-09-29Location: Remote, New JerseyCompany: Planet Pharma GroupContact: ApplicationsEmail: ****@*****.*** OverviewPerform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting...
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