Consumables Development Engineer - Design Control Medical Devices (m/f/d, temporary or freelance, 80-100%)
Consumables Development Engineer - Design Control Medical Devices (m/f/d, temporary or freelance, 80-100%)
Direct message the job poster from Congenius AG
Congenius provides tailored expertise and leadership to global firms, established SME`s and aspiring start-ups in the medical device, IVD and pharmaceutical industry. If you enjoy working with a diverse range of people across a broad range of projects and are passionate about making a positive contribution to the MedTech industry, then joining our dynamic team could be your next rewarding career step.
Your Responsibilities
* Execute projects for customers independently (usually on customer's site) regarding design control activities for medical devices and IVD products within international project teams
* Define design input documents like user requirements, product requirements, and design specifications
* Drive development activities and generate relevant deliverables (i.e., drawings, dimension range analysis, design risk assessment) for medical devices / IVD products
* Responsible for feasibility studies, verification activities (e.g. shelf life, shipping qualification) and manufacturable product design
* Interact with intercompany disciplines (development, production, quality) as well as suppliers
* Solve problems and find solutions with the right balance between state-of-the-art technology, business needs, and compliance
* Act as an integrator between teams and sites
Your Skills and Experience
* Education in mechanical engineering or natural science, at least Bachelor of Science (BSc)
* At least 3 years’ experience in design control and engineering of high production / polymer injection molding
* Excellent knowledge of design control processes, design verification, risk management
* Experience in Lean and Six Sigma methodologies, as well as knowledge in relevant standards and regulations (e.g., ISO 13485, MDR, IVDR, 21 CFR part 820)
* Independent, self-organized, and hands-on approach
* Systematic and analytical thinking with strong problem‐solving capability
* Team player who works efficiently and flexible in interdisciplinary teams
* Decision-maker, taking the lead where appropriate and necessary
* Very good communication skills and ability to gain trust with various stakeholders (from shop floor to senior management)
* Fluent in English and German is a must
* You will work in the Zurich area for an ambitious, dynamic small company in the medical technology sector with a very good working atmosphere
* You benefit from flexible working hours and an exciting and versatile field of activity
* You work in a company with a flat hierarchy, short decision-making processes
* You can expect a pleasant working atmosphere, an uncomplicated and collegial cooperation
* You benefit from modern and attractive working conditions and development opportunities
* An attractive salary and very good social benefits round off the offer
Seniority level
* Seniority level
Entry level
Employment type
* Employment type
Full-time
Job function
* Job function
Project Management, Consulting, and Engineering
* Industries
Operations Consulting, Business Consulting and Services, and Pharmaceutical Manufacturing
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