Principal R&D Engineer

Location: Netherlands

SIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!

THE COMPANY

Our client is a professional Medical Devices organization, based in Noord-Brabant Netherlands.

Highly innovative Medical Devices company.

ROLE DESCRIPTION

My client is looking for an enthusiastic and dedicated experienced engineer with an eye for detail, a pragmatic attitude, and intrinsically motivated to work in a close-knit multidisciplinary team towards the development of a revolutionary new implantable medical device. The successful candidate will play a key role on the team as project engineer, focusing on design, development, and testing in preparation for a FIM clinical study.

RESPONSIBILITIES

Minimum Requirements:
• Experience in designing and testing Structural Heart devices.
• Minimum of five years of experience in medical device development.
• MS degree (EU) or BS degree (US) in mechanical or biomedical engineering
• Knowledgeable in medical device design controls and quality systems per ISO 13485
• Must be a highly-motivated self-starter able to achieve results with minimal direction.
• High-energy individual with a proven track record of accomplishing work independently, demonstrated project ownership and accountability, and collaborative

REQUIREMENTS

skills in prior work.
• Must have the drive and desire to work in a fast-paced team environment.
• Strong problem-solving skills, detail orientation, and a "can do" attitude are essential.
• Must be proactive and creative in solving technical problems.
• Ability to solve technical problems and identify/implement practical solutions based on device requirements and project timelines is an important skill set.
• In depth understanding of mechanical design, dimensioning and tolerancing.
• Excellent verbal and written communication skills, detail orientation and analytical/problem solving skills are a must.
• 2 years CAD modeling experience.
• Proficiency in Minitab

Preferred Requirements:
• Experience in prosthetic tissue heart valves
• Experience in electrospinning
• Experience in Finite Element Analysis (FEA)
• Experience with heart valve testing; hydrodynamic performance and accelerated

wear testing (AWT)
• Proficiency in Solidworks
• Experience in laser cutting

Tasks consist of, but are not limited to:
• Design and develop surgical heart valve device which incorporates electro-spun leaflets for the purpose of facilitating endogenous tissue restoration (ETR)
• Responsible for generation and execution of deliverables related to medical device design controls, including material specifications, drawings, design inputs, FMEAs, test plans, and design verification activities.
• Mentoring of junior level engineers and technicians. The position may have some direct reports.
• Working closely with project team members in Operations, Regulatory, Quality, and Clinical to deliver project objectives.
• Provide leadership for the design control elements of the project.
• Develop and qualify test methods and procedures to be used in device qualification testing.
• Generate test protocols, reports and supporting documentation for design verification purposes.

This is a full-time position.

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Tim Thuijs.