QA Engineer

As a quality assurance engineer you will be responsible for:

• Define and implement the quality management system
• Initiate and manage quality assurance events like Engineering Change Orders, Corrective and Preventative Actions, and Notes to File
• Participate in design of the manufacturing and verification processes
• Take part in quality control activities as needed
• Manage all quality and product records
• Take part in certifying the company to ISO 13485

And you will need to have

• Patience and attention to details
• Investigative abilities to trace information and piece together a coherent narrative
• Creativity and motivation to tackle complex obstacles independently
• Hunger to learn new skills

Minimum Requirements

• Near completion or recent graduate of studies in engineering / life sciences
• Excellent English reading & writing proficiency
• Proficiency with MS Office software suite

Priority Requirements

• Familiarity with ISO 13485 and CFR 21 part 820
• Experience in the medical device industry
• Industry standards for cardiovascular implants and delivery systems

If you meet the above requirements, send us an email:

Clinical Application Engineer

As a clinical application engineer, you will be responsible to:

• Hands-on product support to investigator team during clinical study  
• Train novice operators in new clinical investigation sites
• Routine communication with study stakeholders [coordinators, CRO, core lab]
• Data gathering and management from clinical sites
• Present lessons from clinical experience to R&D team

And you will need:

• Technical ability to understand the product down to component level [for on-site troubleshooting]
• Confidence and calmness in stressful settings [clinical study]
• Travel frequently to clinical sites in the EU and the US
• Ability to motivate stake holders thru positive interactions
• High verbal communication skills in English

Minimum Requirements

• B.Sc. in engineering or life sciences
• 1 year experience in a hands-on product related technical role
• High Proficiency in English language reading/writing/speech

Priority Requirements

• Experience attending clinical environments [cath-lab] and interacting with physicians / investigators
• Experience working under QMS ISO 13485 in a medical device firm

If you meet the above requirements, talk to us! 

R&D Technician

As a technician in the R&D department, you will be responsible to: 

• Assembly in clean-room environment of complex products for clinical use
• Conduct quality control measures like incoming inspections and route card forms
• Assembly in R&D lab of devices under development for bench and pre-clinical studies
• Contribute to production of work instructions

Your will need to have:

• Ability for complex and delicate assembly processes
• Handle changing priorities and tight deadlines if needed
• Independent problem-solving during lab work
• Follow work instructions and contribute to constant improvement of processes

Minimum Requirements

• Experience in clean room work environment
• Experience working under quality management system ISO 13485 in a medical device firm
• Proficient in English language reading

Priority Requirements

• Experience with small & delicate component assemblies under microscope
• Hands-on experience with measurement equipment [microscope, caliper, micrometer etc.]
• Conducting quality control inspections

If you meet the above requirements, talk to us! 

Implant Engineer

As an engineer in the R&D team in charge of implant development, you will be responsible for

• Development of all implant components from bench testing to clinical investigation
• Validate the Nitinol frame design using FEA and accelerated fatigue methods
• Scale the manufacturing capacity [subcontractors, in house assembly, jigs& fixtures, training, supply chain]
• Hands-on fast paced iterative prototyping in-house and at vendor locations

You will need to have

• Can-do attitude with ability to independently tackle challenges
• Ability to work quickly work hands-on in a lab environment
• Ability to manage personal project priorities, push for goals and pull resources from colleagues and vendors as needed
• Generate positive business relationships with vendors

Minimum Requirements

• B.Sc. in engineering - Mechanical / Biomed / Materials
• 2 years' experience in the medical device industry at engineering or R&D capacity
• Medium proficiency using CAD software [Solidworks preferred]
• High proficiency in English language reading and writing

Priority Requirements

• Experience with class III medical devices
• Cardiology structural heart background
• Laser manufacturing processes [cutting, welding, EP, deburring]
• Familiarity with ISO13485 quality system
• Polymer manufacturing processes [extrusion, bonding, blow molding]
• Fatigue testing and other implant V&V related experience

If you meet the above requirements, talk to us! 

Delivery System Engineer

As an engineer in the R&D team in charge of delivery system development, you will be responsible for

• Development of complex catheter-based delivery system including tubing, mechanisms, plastic parts, bonding

• Scaling the manufacturing capacity, incl. injection molds

• Hands-on fast paced iterative prototyping in-house and at vendor locations
• Design custom test protocols and measurement equipment
• Writing work instructions, training colleagues and operators

You will need to have

• Can-do attitude with ability to independently tackle challenges
• Ability to manage personal project priorities, push for goals and pull resources from colleagues and vendors as needed
• Creating and maintaining positive business relationships with global vendors
• Ability to work quickly work hands-on in a lab environment

Minimum Requirements

• B.Sc. in engineering - Mechanical / Biomed / Materials
• 1 years' experience in the medical device industry at engineering or R&D capacity
• High proficiency using CAD software [Solidworks preferred]
• High proficiency in English language reading and writing

Priority Requirements

• Experience with class III medical devices
• Cardiology structural heart background

• Knowledge of catheter manufacturing processes [steerables, extrusions, shrink tubing, braiding]  

• Familiarity with ISO13485 quality system

• Experience with manufacturing processes like machining, bonding, laser welding, injection molding, 3Dprinting

If you meet the above requirements, talk to us! 

TBD - Office Administrator

As an office administrator your responsibilities will include

Minimum Requirements

Priority Requirements

If you meet the above requirements, talk to us!