{"id":343629,"url":"https://alion.io/job/weekday-research-and-development-project-manager","title":"Research and Development Project Manager","company":{"id":7097,"name":"Weekday","domain":"weekday.works","url":"https://alion.io/company/weekday","size_band":"51-200","is_staffing_agency":true,"employer_type":"agency","is_intermediary":false,"listed_via":null,"ats_vendor":"Workable","truth_index":{"grade":"B","score":81,"open_postings":100,"ghost_share":0,"stale_share":0.98,"repost_share":0,"time_to_fill_p50_days":6,"computed_at":"2026-11-09T06:03:00Z"}},"role":"Management","role_family":"Management","seniority":null,"employment_type":"full_time","work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["San Clemente, United 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Clemente, CA (Hybrid)\nCompetitive Salary | Long-Term Role\nVarious shifts might be available, with compensation varying based on the selected shift.\nWe are currently looking for a seasoned Senior Project Manager with extensive experience in Medical Device New Product Development (NPD) to lead enterprise-level R&D projects within a highly regulated healthcare setting.\nThe successful candidate should possess practical expertise in managing products throughout the entire medical device development process - including design inputs, verification and validation, regulatory submissions, and product launch.\nRequirements\nQualifications We Seek:\nExtensive experience in Medical Device New Product Development (NPD)\nIn-depth knowledge of Design Controls\nProven background in supporting FDA 510(k), MDR, and other regulatory submissions\nCapacity to perform effectively in fast-paced and ambiguous R&D settings\nDemonstrated track record of driving alignment across cross-functional teams including R&D, Regulatory, Quality, Operations, and Supply Chain\nExperience with supporting product launch and ongoing sustaining engineering efforts\nPrimary Responsibilities:\nLead complex R&D and New Product Development initiatives within FDA-regulated contexts\nOversee project execution from initial concept through to commercialization\nManage schedules, budgets, resources, risks, and deliverables associated with projects\nCoordinate multidisciplinary teams such as Regulatory Affairs, Quality, Manufacturing, Operations, Marketing, and Supply Chain\nSupport design control activities, including product performance, assembly integrity, safety, labeling, packaging, as well as verification and validation tasks\nCollaborate with stakeholders to establish project scope, validation strategies, and requirements in dynamic development environments\nEnsure compliance of all projects with FDA, ISO 13485, GMP, and MDR standards\nDeliver executive-level project status updates and communications\nRequired Qualifications:\nBachelor’s degree mandatory\nMinimum of 4 years’ experience in Project Management within Medical Device or regulated healthcare industries\nExperience in Design Controls and Medical Device Development Lifecycle\nStrong comprehension of NPD processes and regulatory frameworks\nSkilled in MS Project, Excel, PowerPoint, SharePoint, and other related project management tools\nThis role represents a fantastic opportunity for a self-driven individual who excels in early-stage product development and can lead execution across multiple teams independently.\nMust-have skills\nR&D medical device Medical Devices Medical Device R&D Biomedical Device Design Biomedical 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