Beschreibung
Subject Matter Expert Electronic Subject Matter Expert ElectronicDuration: 6 months
Location: Canton of Vaud, Switzerland
Position Summary:
Provide design and project management support in electronic for a large suite of complex medical devices enhancements and obsolescence projects that enable improved cost, quality and the continued supply of product for worldwide operations. This position is responsible for the selection of approach, materials, methods, means and documentation for approving and validating output. Must manage multiple projects of varied scope and adapt process steps including associated documentation part of the DMR and DHF operations.
Activities, Duties, Task and Responsibilities
Technical Development and Analysis
- Identifies released product design and manufacturing process issues, evaluates critical nature, determines root cause, develops design and process solutions, and implements solution.
- Designs, develops, prototypes, measures, and tests electronics and hardware
- Works cross-functionally to ensure design addresses internal & external needs
- Effectively utilizes broad knowledge of materials and manufacturing processes to create and maintain documentation suitable for regulatory submissions
- Provides hands-on support for products from commercial release to end of life.
CMO, OEM management & coordination
- Plan, monitor, technical control and documentation of activities of CMO, Supply Chain, Procurement, and QA
- Key communication / coordinator between suppliers and company
- Contributes to the Business Review Meeting: operation engineering and sustaining part.
Quality, Compliance, and Regulated Regulatory Practices
- Perform work in adherence to the Quality Management System (QMS), including development and maintenance of documentation
- Ensures product meet requirements regulated by FDA, UL, CE and other governing bodies
- Participates in selection of vendors and fabrication sources to assure quality and compliance to released specifications.
Project Management and Documentation
- Rigorous documentation for all phases of projects (supervise or contribute), including design specifications, verification test plans, project schedules, drawings, and change orders associated with medical devices and consumable products.
- Routine communication with peers and supervisors including documentation of work, meetings, and decisions
- Develops & maintains budget, project plans, coordinates project activities, sets/adheres to milestones, ability manage concurrent projects
- Ensure that meetings, project reviews and action lists are kept current and communicated to all stakeholders in a timely fashion
- Direct outside contract personnel as needed for completion of specific tasks.
Technical Contribution and Project Management leadership
- Provide work direction, coaching, and guidance to Jr team members
- Promote peer development and foster team growth through:
- Demonstrated excellence in technical contribution
- Open dialog with peers to share experience and knowledge
- Strategy production tools align to the capacity Continuous demonstration of Project
- Management best practice.
Qualifications (Knowledge, Skills & Abilities):
Minimum:
- Master in Electromechanical / Electronical Engineering or Equivalent Education and/or Experience
- Proven Experience working with Electronical CAO (Altium or equivalent)
- 10 years' experience in the Medical Device industry
- 10 years' experience in an engineering role, preferably as a manufacturing engineer
- Comfortable with Quality System and Medical Standards, ISO, MDR, IQOQ, DFM, FMEA, ECF
- Strong interpersonal and communication skills in multicultural environment
- Fluent in English
Preferred:
- Deep DFM, FMEA, statistical analysis knowledge/understanding
- Statistical Data Analysis (Minitab)
Sthree Switzerland is acting as an Employment Business in relation to this vacancy.