Direct message the job poster from Capgemini Engineering
Talent Acquisition Professional at Capgemini Engineering
Are you passionate about developing innovative medical devices that improve lives? We are seeking a Medical Device Engineer to join our dynamic team, dedicated to advancing cutting-edge drug delivery systems. In this role, you will collaborate with multidisciplinary teams to design and develop high-quality combination products that enhance patient outcomes around the world.
Responsibilities
* Design Development Plans
* User Requirements Specifications (URS)
* Design Inputs & Outputs
* Conformity Assessments and DHF (Design History File) management
* Project Execution: Drive projects from concept to completion within agreed timelines, budget, and quality standards, ensuring the successful development of state-of-the-art drug delivery systems (e.g., autoinjectors, parenteral devices).
* Regulatory Compliance: Apply knowledge of regulatory standards to ensure designs meet global compliance requirements, including ISO 13485, ISO 14971, 21 CFR 820, and 21 CFR 820.30.
* Cross-Functional Collaboration: Work closely with R&D, Quality, Regulatory, and Manufacturing teams to align product development with business and patient needs.
Requirements
* University degree in Mechanical Engineering, Biomedical Engineering, or a related field.
* 5+ years of experience in mechanical engineering and drug delivery device development.
* Proven expertise in regulated environments (Pharma, MedTech) under cGxP, QSR, or equivalent.
* In-depth knowledge of combination product regulations and industry practices.
* Knowledge of drug delivery devices, parenteral drug delivery, risk assessment, tolerance analysis, statistical techniques, process capability, manufacturing processes, transportation studies, and validation.
* Experience with Health Authority interactions is a plus.
* Excellent skills in documentation, communication, and technical presentation.
* Fluent in English; proficiency in German is a plus.
If your profile matches the requirements of the position, we will contact you within the next fifteen (15) days of submitting your application. Otherwise, please kindly consider that your application is unsuccessful.
Please note, that we only accept applicants with Swiss or EU/EFTA citizenship or applicants with an existing and valid residence and work permit for Switzerland.
Capgemini Engineering is an EEO and Affirmative Action Employer of Females/Minorities/Individuals with Disabilities.
Our offer
* A permanent contract with the leader in innovation and high-tech engineering consulting.
* A multi-stage model with career opportunities through specialization prospects with over 250'000 consultants around the world and a Group revenue of EUR. 17 Bn, the Capgemini Group is the undisputed global leader in Engineering and R&D services (ER&D).
* In Switzerland, Capgemini employs more than 400 consultants and aims towards large growth with offices located in Zürich, Basel, Bern, Lausanne and Geneva.
* 30% to 70% remote work in agreement with your line manager and client needs.
* Trust-based managerial culture.
* Team rituals and get togethers.
* Options to order ergonomically proven Equipment (monitor & chair) for your home office premises.
Seniority level
* Seniority level
Mid-Senior level
Employment type
* Employment type
Full-time
Job function
* Job function
Consulting and Engineering
* Industries
Engineering Services, Pharmaceutical Manufacturing, and Medical Equipment Manufacturing
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