Senior R&D Engineer
Posted on Mar 14, 2021 by Michael Bailey Associates - Amsterdam
About the job
Senior technical team member and individual contributor to the design and development of next generation bioresorbable vascular grafts which utilize endogenous tissue restoration (ETR). Successful candidate will play a key role in a cross-functional product development team focusing on design, development, testing, production and overall support in an early clinical phase of the product.
- Design and develop next generation vascular graft devices comprising electro-spun bioresorbable polymers 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, reports and design verification activities.
- A senior technical team member in a small team of engineers, scientists and technicians. Must be able to translate theoretical test concepts into reality.
- 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.
- Develop and qualify manufacturing and test equipment
- Develop timelines for projects and ensure goals are being met.
- Compile and analyse data, prepare documentation, and make recommendations for changes and/or improvements.
- Generate test protocols, reports and supporting documentation for design verification purposes.
- Other duties as required
- Candidates must possess a bachelors or advanced degree in Engineering (Mechanical engineering preferred) or a Scientific discipline from an accredited College or University
- Proven record of success in managing details in a regulated environment.
- Minimum of 3+ years of industry experience in medical device development.
- 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.
- Demonstrated leadership skills providing work direction to a multi-functional team including internal and external resources.
- Proven track record of ability to resolve complex problems.
- The ability to work well with other groups in a collaborative environment.
- Must be proactive and creative in solving technical problems.
- In-depth understanding of mechanical design, dimensioning and tolerancing.
- Proficient in creating mechanical drawings per ISO or ASME standards is preferred.
- 1-2 years 3D CAD modelling experience (Solidworks proficiency is preferred).
- Experience developing test & manufacturing equipment is preferred
- Experience in prior cardiovascular medical device projects is preferred.
- Experience in electrospinning is preferred.
- Excellent written and spoken English communication skills.
Michael Bailey International is acting as an Employment Agency in relation to this vacancy.