新产品导入项目经理
Program Manager, NPI
Willow 是一个帮助改善女性生活和健康的系列产品平台。我们是一支以使命为导向的团队，成员包括经验丰富的发明者、母亲和父亲，致力于为女性的生活带来改变。Willow™ 可穿戴式吸奶器曾被选为 2017 年和 2018 年《时代》杂志评选的 25 项最佳发明之一，并获得 2018 年 CES 创新奖——可穿戴技术类奖项，是该平台上的首款解决方案。
职位概述：
Willow 正在寻找一位经验丰富的项目经理，负责我们联网医疗设备的新产品引入（NPI）。此职位需要与硬件、固件、软件、法规/质量、临床和制造团队紧密合作，将安全、可靠且联网的产品推向市场。项目经理将推动需求收集、设计控制和可行性分析，并执行跨职能计划，从概念阶段到发布和持续支持，达成关键项目里程碑。
你将负责：
- 管理联网医疗设备的复杂跨职能 NPI 项目，从概念到设计、验证和确认、转移到制造以及持续支持。
- 与硬件、固件、移动端/应用、法规、质量及临床团队协作，定义需求、设定优先级并确定范围、预算和时间表。
- 按照 ISO 14971 标准推动项目层面的风险管理，识别、评估并缓解产品生命周期中的技术、法规和进度风险。
- 与质量和法规事务团队合作，负责并维护项目时间表、设计历史文件（DHF）里程碑和阶段门交付物。
- 作为功能负责人的重要助力，解决各类问题，主动消除障碍并促进跨团队决策。
- 与软件和安全团队协调设备连接工作流（如蓝牙/BLE、配套应用、云/数据集成），确保一致的用户体验。
- 提出建议，获得相关方共识，并清晰地向管理层汇报项目状态和风险。
- 与运营和合同制造商合作，支持设计转移和制造准备活动。
你将具备：
- 12 年以上工作经验，其中 5 年以上在医疗设备或其他受监管的软硬件行业担任项目或产品经理的经验。
- 本科及以上学历优先，或同等经验。
- 具有联网或机电类产品的 NPI 项目管理经验。
查看英文原文
Willow is a platform for products that help improve the lives and health of women. We are a mission-driven team of experienced inventors, mothers, and fathers dedicated to making a difference in women’s lives. The Willow™ Wearable Breast Pump, selected as one of TIME's 25 Best Inventions in 2017 and 2018 CES Innovation Award for Wearable Technologies, is the first solution in our platform.
Job Overview:
Willow is seeking an experienced Program Manager to lead new product introduction (NPI) for our connected medical devices. This role requires close collaboration with hardware, firmware, software, regulatory/quality, clinical, and manufacturing teams to bring safe, reliable, and connected products to market. The Program Manager will drive requirements gathering, design controls, and technical feasibility, and will execute cross-functional plans to hit key program milestones from concept through launch and sustaining.
What you'll do:
- Manage complex cross-functional NPI programs for connected medical devices, from concept through design, verification and validation, transfer to manufacturing, and sustaining.
- Collaborate with hardware, firmware, mobile/app, regulatory, quality, and clinical teams to define requirements, set priorities, and establish scope, budget, and timelines.
- Drive program-level risk management (per ISO 14971) by identifying, assessing, and mitigating technical, regulatory, and schedule risks throughout the product lifecycle.
- Own and maintain program schedules, design history file (DHF) milestones, and phase-gate deliverables in partnership with quality and regulatory affairs.
- Be a force-multiplier for functional leads to resolve issues, proactively removing obstacles and facilitating cross-team decision making.
- Coordinate device connectivity workstreams (e.g., Bluetooth/BLE, companion app, cloud/data integration) with software and security teams to ensure a cohesive user experience.
- Develop recommendations, gain stakeholder alignment, and communicate program status and risks clearly to leadership.
- Support design transfer and manufacturing readiness activities in collaboration with operations and contract manufacturers.
What you'll bring:
- 12+ years of experience, with 5+ years of program or project management in medical devices or another regulated hardware/software industry.
- Bachelor's degree or higher preferred, or equivalent experience.
- Experience leading NPI programs for connected or electro-mechanical medical devices through the full lifecycle, from concept to launch and sustaining.
- Working knowledge of FDA QSR (21 CFR Part 820), ISO 13485, IEC 62304, and ISO 14971, and experience partnering with regulatory/quality teams to meet design control requirements.
- Experience coordinating hardware, firmware, and connected software/app workstreams within a single program.
- Experience using Atlassian tools such as JIRA & Confluence for project management, analysis, and reporting.
- An ability to communicate technical problems and solutions clearly to diverse audiences at all levels of the organization.
- A strong sense of ownership, urgency, and drive.
- An agile project management style, approach, and execution.
- Strong familiarity with project management software tools (e.g. SmartSheet, JIRA/Atlassian), methodologies, and best practices.
- Project Management Professional (PMP) or Program Management Professional (PgMP) certification preferred.
Willow is proud to be an equal opportunity workplace. We are committed to equal employment opportunities regardless of gender, race, religion, sexual orientation, gender identity, age, marital status, disability, or Veteran status.
Originally posted on Himalayas