Beschreibung
For our medical device client in Solothurn area, we are looking for a Senior Development Engineer for a contract role.
Overall responsibilities
* Responsible for product transfers and improvements/modifications of existing implants and instruments.
* Lead of Lifecycle Management activities (DHF and TF updates) for existing Trauma/CMF (Cranio-maxillo-facial) Product systems.
* Coaching of junior engineers and interns in technical aspects of product improvements/modifications and Technical File update and maintenance.
Position duties and responsibilities
* R&D Sustaining Engineering point of contact for product transfers
* Responsible for product design, specifications and functional requirements.
* Responsible for answering technical questions for existing Trauma/CMF portfolio and coordinates between clinical and technical project partners.
* Leads and reviews corrective and preventive actions (CAPA) and represents technical documentation in internal and external Audits.
* Leads, develops and defines product verification and validation activities as part of product performance and product safety.
* Close collaboration with the technical engineering office to generate product models, concept layouts, and prints (CAD).
* Proper application of GD&T (Geometric Dimensioning and Tolerancing) and other engineering tools.
* Independent development and coaching of younger engineers in mechanical test setups (including definition of benchmarks) according to product specific application and/or national and international standards.
* Leads activities to fabricate test parts for verification & validation tests.
* Collaborate with manufacturing during the design stages to incorporate manufacturability into the product designs and during the implantation phase to clarify design issues.
* Ensure compliance with national and international regulations related to medical devices (in particular to EU MDD, US FDA, Japanese PAL)
* Know and follow all laws and policies that apply to the job while maintaining the highest levels of professionalism, ethics, and compliance at all times
Your Profile
*Qualification from College of Higher Education (HTL, HF) plus 5-6 years' practical experience
or
University/ETH course [Swiss Federal Institute of Technology] plus 3-5 years' practical experience
or
Vocational qualification plus at least 7 years' practical experience and supplementary on-going professional training (eg master craftsman/technician and specialist diploma (eg FH)
* In-depth knowledge in Mechanical/Biomechanical Principles
* Knowledge in Materials Science, Biology & Anatomy is a plus
* Experienced in the use of spread sheet and CAD
* Strong mechanical experience (construction, concepts & production)
* Extensive project management experience
* Creative with problem-solving skills
* Good planning and execution skills
* Essential to accept responsibility
* Independent and proactive
* Experience in coaching others is a plus
* Team player
* Strong communication skills
- German: Business proficiency preferred to facilitate smooth cross functional co-operation
- English: Business fluent (oral & written)
Non-Technical profile requirements:
- Some flexibility in working hours is required
- Must be able to work on multiple simultaneous tasks with limited supervision;
- Quick learner, motivated self-starter;
- Excellent customer service, interpersonal, communication and team collaboration skills;
- Able to follow change management for internal guidelines.
Language proficiencies:
-English and Swiss German spoken and written;
Would you like to apply for this job opportunity?
Please send me your updated CV (see below) or feel free to contact me.
I am looking forward to hearing from you.