深圳招聘

Summary:

Provide a role for implementation and execution of software quality process according to existing software development process and design control process. Assure guide team members for compliance to validation and verification process and applicable standards. Work closely with software research and development to create high quality software products that meet our customer’s needs by performing or managing the following duties:

Essential Duties and Responsibilities: (Other duties may be assigned)

· General – Plan, develop and execute unit and integration tests for new and existing medical device software.

· Standards – Understand applicable medical device software standards such as:

- IEC 62304, Medical Device Software – Software Life Cycle Processes

- ISO 14971, Application of Risk Management to Medical Devices

- AAMI TIR 32, Software Risk

- FDA Guidance, General Principles of Software Validation

- FDA Guidance, Off-the-shelf Software use in Medical Devices

· Team Guidance – Provide guidance to the team on verification and validation strategy.

· Test Requirements – Review product requirements, engineering designs and user documentation. Understand how software requirements relate to overall system requirements. Provide traceability back to the software requirements specifications and customer requirements.

· Test Environments – Design & built test environments that emulate customer environments.

· Documentation – Develop documentation to support building of test environment, test protocols and reports.

· Problem Reporting – Find, investigate and report product problems, representing the customer’s interest in R&D.

· Communicate Results- Communicate product quality assessments, metrics and status across all levels of the organization.

Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

Education/Experience:

BS in Computer Science or a related technical field, or equivalent experience.

At least three (3) years of SQA experience in planning, creating and executing test cases.

Familiarity with one programming language.

Ability to perform administration duties in MS Windows environment.

Excellent analytical and troubleshooting skills with the ability to read system logs effectively.

Language Ability:

Fluent in English. Ability to read, analyze, and interpret common scientific and technical documents and programming codes. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or customer service. Ability to effectively present information to the team and public groups.

Reasoning Ability:

Ability to define problems, collect data, establish facts, and draw valid statistical conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form.

Additional Computer Skills:

Software Configuration Management, Software Defect Tracking, Word processing, spreadsheet, Internet, e-mail, and database software

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Accommodations:

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Broncus Medical成立于1998年，隶属于德诺集团。
德诺医疗集团：
国际前沿的医疗器械集团，致力于为严重威胁人类健康但目前缺乏有效手段的重大疾病寻求有效治疗方案。
德诺医疗致力于创新性产品的研发，目前拥有全肺微创精确诊疗平台、外周血管介入、结构性心脏病介入、心脏瓣膜修复、心衰等十多个项目，涵盖心血管和周围血管微创介入及肺部诊疗领域，在中国深圳、美国、以色列、中国香港均设有多个研发中心。员工总数近千人，其中超过15%为海外员工。
德诺目前拥有各类专利1000多个。自2012年以来，引进投资超过6亿美元，2018年开始实现销售，2019年集团销售3.8亿人民币，预计2020年达到8亿，2022年突破20亿。
总部杭州现有17000平米的研发和生产基地，预计三年后会建成德诺自有浦沿产业园（近之江大桥），临近钱塘江，占地65亩。银行、跑道、健身房、餐厅、托儿所等各种配套设施都将入驻园区。园区中还包含有37亩的水系公园作为德诺后花园。