出海雷达

嵌入式软件架构师

Embedded Software Architect

开发工程限定地区(需当地身份)
公司Abbott
薪资未公开
工作地点Romania
地域资格限定地区(需当地身份)
时区要求日间重叠约 3 小时,需偶尔早起或晚睡
用工类型Full Time
发布时间13 天前
数据来源Himalayas
前往 Himalayas 查看并投递 →
注意地域限制:该职位明确限定在 Romania 招聘。如果你是位于中国大陆的求职者,通常需要当地工作身份才能投递,或需与雇主确认是否接受独立合同(Contractor)形式合作。

职位描述:
Abbott Rapid Molecular Diagnostics 是 Abbott 诊断业务部门的一部分,汇集了优秀的专家团队和行业领先的科技,为现场诊断测试提供支持,为疾病和其他状况的治疗和管理提供重要信息。

负责领导新型医疗设备自动化测试框架的设计与实施,重点在于嵌入式系统和云连接解决方案的验证与确认(V&V)。提供战略指导以确保符合监管要求并提高测试效率。与海外跨职能团队协作,支持安全、高质量产品的交付,并参与早期概念开发和可行性评估,从一开始就嵌入可测试性和质量。

职责:
· 参与早期开发中的产品概念和设计测试策略。
· 领导新测试技术的可行性研究及流程整合。
· 作为团队负责人,领导并协调医疗设备软件的验证与确认(V&V)活动,确保符合监管标准(例如 FDA、ISO 13485、IEC 62304)。监督测试计划、执行和缺陷管理,同时指导团队成员,跨职能协作,并推动测试流程和质量保证的持续改进。
· 推动自动化策略、工具选择和模块化测试框架设计。
· 开发并维护覆盖软件、GUI 和硬件层的测试套件。
· 通过强大的测试计划和可追溯性,在 SDLC/STLC 各阶段确保质量。
· 监督工具验证、文档和审计准备。
· 指导团队在自动化、编码实践和监管标准方面的工作。
· 定义代码审查、版本控制和可重用测试资产的标准。
· 组织研讨会并推动持续学习计划。
· 与利益相关者和管理层对接,确保测试与项目目标和时间表一致。
· 与外部合作伙伴协作并管理供应商的贡献。
· 通过敏捷方法、指标和现代工具,推动测试流程的持续改进。
· 评估新兴技术(例如在测试嵌入式设备或云平台中使用 AI/ML)。
· 规划/组织-规划和组织具有相当多样性和复杂性的项目任务。发起或维护项目的计划和里程碑。建立优先级

查看英文原文

JOB DESCRIPTION:
Abbott Rapid Molecular Diagnostics is part of Abbott’s Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies to support point of care diagnostic testing that provides important information for treatment and management of diseases and other conditions.

Responsible for leading the design and implementation of automated testing frameworks for novel medical devices, with a focus on verification and validation (V&V) of embedded systems and cloud-connected solutions. Provides strategic guidance to ensure regulatory compliance and testing efficiency. Collaborates with offshore cross-functional teams to support the delivery of safe, high-quality products, and contributes to early concept development and feasibility assessments to embed testability and quality from the outset.

RESPONSIBILITIES:
· Contribute to product concepts and design-for-test strategy in early development.
· Lead feasibility studies for new test technologies and integration into workflows.
· As a team lead, lead & coordinate the verification and validation (V&V) activities for medical device software, ensuring compliance with regulatory standards (e.g., FDA, ISO 13485, IEC 62304). Oversee test planning, execution, and defect management, while mentoring team members, collaborating cross-functionally, and driving continuous improvement in test processes and quality assurance.
· Drive automation strategy, tool selection, and modular test framework design.
· Develop and maintain test suites across software, GUI, and hardware layers.
· Ensure quality across SDLC/STLC phases through robust test planning and traceability.
· Oversee tool validation, documentation, and audit readiness.
· Mentor teams in automation, coding practices, and regulatory standards.
· Define standards for code reviews, version control, and reusable test assets.
· Facilitate workshops and drive continuous learning initiatives.
· Interface with stakeholders and management to align testing with project goals and timelines.
· Collaborate with external partners and manage vendor contributions.
· Lead continuous improvement of test processes via Agile, metrics, and modern tools.
· Evaluate emerging technologies (e.g., AI/ML in testing embedded devices or cloud platforms).
· Planning/Organization-Plans and organizes project assignments of substantial variety and complexity. Initiates or maintains schedule for projects and project milestones. Establishes priorities of individual or project assignments.

  • Influence/Leadership-Understands business environment and relates extensive knowledge of internal and external technological activities to trends.
  • Researches, develops, designs, and evaluates mechanical and electro-mechanical materials, components, assemblies, processes and/or equipment.
  • Conducts feasibility studies to verify capability and functionality.
  • Develops new concepts from initial design to market release.
  • Directs support personnel and coordinates project activities.
  • Write and submit intellectual property (patents).
  • Maintains detailed documentation throughout all phases of research and development.
  • Investigates and evaluates existing technologies.
  • Reviews or coordinates vendor activities to support development.
  • Write and submit professional articles for technical journals.
  • Influence/Leadership-Understands business environment and relates extensive knowledge of internal and external technological activities to trends.
  • Interfaces with senior management on significant matters, often requiring the coordination of activity across organizational units.
  • Participates in the development of other technical contributors by facilitating training and providing feedback and guidance.
  • May lead a project team.
  • Provides technical leadership to business units. Acts as a mentor to less-experienced staff and may provide work direction or supervise other technical employees.
  • Exercises judgment independently.
  • Decision Making/Impact-Selects methods and techniques to lead a project to completion. Erroneous decisions or recommendations would typically result in failure to achieve major organizational objectives.

MINIMUM QUALIFICATIONS | EDUCATION/EXPERIENCE:
· Bachelor of Science, Software Engineering, Biomedical Engineering, Electrical Engineering, Mechanical Engineering or equivalent

PREFERRED QUALIFICATIONS:

  • Master’s degree of Science, Software Engineering, Biomedical Engineering, Electrical Engineering, Mechanical Engineering or equivalent
  • 9+ years of experience in architecting, designing, developing, debugging, reviewing and testing embedded software and at least 2 years leading teams of embedded engineers in that minimum 6+ years- of experience in medical device engineering, verification & validation, or related fields, minimum 5+ years - leading test automation efforts for regulated medical devices (FDA Class II/III experience highly desirable).
  • Technical/Business Knowledge (Job Skills)-Comprehensive knowledge of a particular technological field.
  • Uses in-depth knowledge of business unit functions and cross group dependencies/ relationships.
  • Is recognized as an expert in work group and across functions.
  • Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations.
  • Cognitive Skills-Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors.
  • Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
  • Has broad knowledge of various technical alternatives and their potential impact on the business.
  • Associate Certified Coach (ACC) ICF certification

COMPETENCIES:

  • Drives for Results: Acts ethically and takes accountabilityfor achieving outcomes.
  • Fosters Collaboration: Comfortable with ambiguity. Implements change when needed.
  • Focuses on Customers: Promptly and effectively handles issues and problems.

An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities. To request an accommodation, please contact your local HR department.
The base pay for this position is
N/AIn specific locations, the pay range may vary from the range posted.
JOB FAMILY:
Product DevelopmentDIVISION:
ID Infectious DiseaseLOCATION:
Romania : RemoteADDITIONAL LOCATIONS:
WORK SHIFT:
StandardTRAVEL:
Not specifiedMEDICAL SURVEILLANCE:
Not ApplicableSIGNIFICANT WORK ACTIVITIES:
Not ApplicableOriginally posted on Himalayas

本页面信息整理自 Himalayas,版权归原发布方所有。职位可能随时关闭,投递请以原始页面为准。 本站只做信息聚合展示,不参与招聘流程,也不向求职者收取任何费用。

该公司其他在招职位

药房区域经理

AbbottChinaFull Time昨天
市场运营职能支持明确接受中国求职者

客户主管

AbbottChinaFull Time4 天前
市场运营职能支持明确接受中国求职者

高级销售代表

AbbottChinaFull Time17 天前
市场运营职能支持明确接受中国求职者

← 返回全部职位