Project Manager, Product Development
# Project Manager, Product Development **Medica** · Bedford, MA 01730 · `On-site` 🕒 **Статус:** *Опубликовано: 8 дней назад* · *Источник: Indeed* --- ### About the Role Overview Medica is seeking a Product Development Project Manager to lead complex, cross-functional diagnostic medical device programs from conception through commercialization. This highly visible role will guide multidisciplinary teams through verification and validation, regulatory submission, design transfer, manufacturing readiness, and commercial launch. The Project Manager will initially lead a major diagnostic platform through its remaining development and commercialization milestones, with the role expanding over time to lead additional new diagnostic programs as they progress through the product development pipeline. Working with technical leads and functional leaders across R&D, quality, regulatory, manufacturing, and marketing, the Project Manager will own integrated project execution and bring structure, visibility, and momentum to new product development in a regulated environment. The ideal candidate combines medical device development experience with exceptional project leadership. They can translate complex technical work into actionable integrated plans, identify critical dependencies before they become schedule problems, facilitate timely cross-functional decisions, and communicate clearly from the working team through executive leadership. Responsibilities - Own integrated project planning and execution for new diagnostic medical device programs through commercialization. - Establish and maintain project scope, schedules, milestones, budgets, resource plans, critical paths, and cross-functional dependencies. - Drive accountability for project deliverables and provide clear visibility into progress, risks, issues, decisions, and forecasted milestones. - Lead cross-functional project teams, facilitate timely decision making, and ensure key decisions and action items are documented and followed through to completion. - Maintain project-level risks, assumptions, issues, and dependencies (RAID); drive mitigation plans and escalate issues requiring leadership intervention. - Provide concise project status, resource needs, major risks, and decision requests to senior leadership. - Coordinate verification and validation, regulatory, design transfer, and commercialization activities so that technical and operational workstreams remain aligned with the overall project plan. - Partner with quality and regulatory to ensure project execution aligns with the Quality Management System (QMS), design controls, and applicable regulatory requirements. - Coordinate the completion and readiness of required project and Design History File (DHF) deliverables for phase-gate reviews, regulatory submissions, design transfer, and launch. - Collaborate with product development leadership and other project managers to improve project management practices and product development execution. Skills - Working knowledge of medical device design controls, Quality Management Systems, and applicable standards and regulations, including FDA Quality Management System Regulation (QMSR), 21 CFR Part 820, ISO 13485, and ISO 14971. - Experience with integrated hardware/software product development; diagnostic instrument, consumable, assay, or other multidisciplinary medical technology experience is preferred. - Experience with project management tools such as Smartsheet, Microsoft Project, Jira, or equivalent platforms. - Strong communication, facilitation, organizational, and time management skills, with the ability to lead through influence in a cross-functional environment. Minimum Qualifications - Bachelor's degree in engineering, life sciences, product management, business, or a related field. - 3+ years of project or program management experience in a regulated product development environment. - Experience in medical devices, diagnostics, or life sciences is preferred. - PMP or another recognized project management certification is a plus. - Demonstrated experience leading complex, cross-functional product development programs with responsibility for schedule, risk, resources, dependencies, and execution. - Experience supporting or leading a regulated product through major development milestones such as verification and validation, regulatory submission, design transfer, and commercialization. Pay: $95,000.00 - $135,000.00 per year Benefits: - 401(k) - 401(k) matching - Dental insurance - Flexible spending account - Health insurance - Life insurance - Paid time off - Retirement plan - Tuition reimbursement - Vision insurance Education: - Bachelor's (Required) Ability to Commute: - Bedford, MA 01730 (Required) Work Location: In person
Наблюдалась 2026-09-29, впервые 2026-09-21, источник — Indeed.