Product Design Engineers - Netherlands
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- Our company is looking for experienced medical device design engineers, who will be responsible for the design of leading edge and innovative medical device products from the concept and system partitioning phase through to the system integration and filing.
- You will also be responsible for the key architecture decisions and ensuring the product meets all regulatory requirements (Medical, Data Protection, etc.) required to launch in global markets. The roles cover both industrial design and biomedical engineering functions.
- You have a passion for, and experience in developing medical products that have been brought to market.
- You are comfortable in developing products in a regulated environment to a strict development methodology focussed on solving end-user needs.
- You are an inquisitive and creative individual who is driven by a desire to change lives through innovative, human-centred product design.
- You will work together with the other developers in a close-knit team to deliver new and ground-breaking products for patients with positional sleep apnea.
Duties and Responsibilities
- Development in a regulated environment - ISO13485 / IEC 62304 / and 21 CFR 820 standards & guidelines.
- Technical leadership within the assigned engineering function.
- Write product design specifications, risk assessments, test protocols, reports and other documentation relevant to the development of the product.
- Write product instructions / user manuals / work instructions.
- Manage 3rd party suppliers to deliver according to the project plans (supplier management).
- Ability to develop and meet project schedules
- Design and develop product or assigned parts of the product or product family (hardware, software, mechanical/ Industrial Design or packaging).
- Design, test and document real- time embedded systems.
- Assure the quality of software and products through good design, review and testing.
- Develop our company's medical products with a focus on performance, usability, scalability, security, data privacy and stability.
- Ensure compliance to Design for Manufacture, Test, Assembly and Cost objectives of the project.
- Application of best practices in Design Controls, Product Lifecycle Management, Configuration Management, Phase Reviews.
- Masters Degree (or equivalent) in an applicable Industrial design, Software/Electronic Engineering or Computer Science field.
- Medical device domain knowledge and expertise in design for products that were successfully approved and launched.
- Experience in developing with compliance to IEC 62304, ISO 13485 and 21 CFR 820 standards.
- Familiar with technology, processes and a variety of the medical field's concepts, practices, and procedures.
- Demonstrable experience and applicable expertise in requirements gathering, product specifications, design of medical devices and interoperability with external applications and other 3rd party components.
- Project management, interpersonal and communications skills.
- Analytical abilities and problem-solving skills.
- Highly adept in balancing timely delivery to various internal and external customers; be a natural problem solver with an innovative approach and be highly intelligent and resourceful.
- Experience in managing 3rd party development & manufacturing suppliers.
- Excellent communication skills in English and/or Dutch.
- An attractive & competitive market salary and benefits.
- An inspiring working environment where autonomy is appreciated.
- An organisation where professional and personal growth are important.