Python Job: Medical Device Engineer Software, 100%, m-f-d

General Description

As a part of the engineering team, the person in this position acts as subject matter expert for medical device software. Manages the requirements from start (User requirements) to validation. Manages changes of software as part of our production environment and our product’s life-cycle management. Conducts software verification and validation according to the guidance of the Regulatory Affairs department. Manages R&D projects meeting timelines and budget. Supports other departments in technical matters. A motivated, self-organizing individual with strong analytical and communication skills.

Key Responsibilities

• Subject matter expert for medical device software
• Creation and management of requirements from start to validation.
• Writes change requests of software as part of our production environment and our product’s life-cycle management in close collaboration with the regulatory and manufacturing team
• Creation and maintenance of the technical documentation on engineering matters throughout the life-cycle of product components of an active implantable medical device system in accordance with the company’s quality management system
• Software verification and validation according to the guidance of the Regulatory Affairs department
• Support the Regulatory and Quality Affairs team in technical matters
• Technical performance and root-cause analysis of software used in product components or engineering and manufacturing test equipment
• Software development according to IEC 62304 standard
• Management of internal and external resources within software development projects

Key requirements

• Good understanding of medical device development process.
• Familiarity with ISO13485, FDA 21CFR820 and IEC 62304
• Proficient with software design, code development, code review and software release
• Experience in application development in C#, SQL database.
• Strong analytical skills
• Ability to formulate complex technical content in an understandable way and according to regulatory guidance
• Ability to work well independently and cross-functionally as part of an established team
• Strong communication skills both verbally and in writing
• Organized, reliable, attention to detail

Nice to have:

• Experience in cloud development
• Experience in python and cybersecurity in medical devices are beneficial.

Required Education / Experience

• BSc or equivalent degree in computer science engineering or related
• Minimum of 3 years experience in software development
• Minimum of 2 years experience in a medical device or highly regulated industry

(Keywords: Software, Medizintechnik, medtech, embedded, Entwickler, Zürich, bevorzugt, C+, C++, C#)

Job Types: Full-time, Permanent

Salary: CHF95,000.00 - CHF110,000.00 per year

Benefits:

• Company events
• Company pension
• Free drinks
• Free parking
• Insurance services
• Long-term profit-sharing plan
• Work from home

Schedule:

• Monday to Friday
• No weekends

Work Location: One location