Careers at InnovHeart
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We provide a stimulating and enjoyable work–life environment and the opportunity to contribute to some of tomorrow’s most exciting medical breakthroughs. We have a collaborative working style that highlights teamwork and trust.
Our team is passionate about making a positive difference everyday. We are proud of what we do, together.
Want to make a difference? Join us today!
Open position: Sr. R&D Engineer, Italy
We are looking for a Sr. R&D Engineer who will collaborate within the R&D team to the development, verification and validation of device, implant system, implant procedure and manufacturing processes.
Is responsible to perform design and development of systems, subsystems, assemblies, components and finished devices;
-defining the design criteria;
-defining the key elements for design verification.
Collaborates to the development of manufacturing processes;
-processes definition and development;
-creates working instruction;
-defines tooling and fixtures;
-defines and develop inspection procedures;
-supports the inspection processes validation;
-provides suppliers support for development and validation of external processes;
-guarantees processes monitoring and stability by KPI uses.
Supports experimental activities;
-supports in-vitro and in vivo testing by testing definition and testing management;
-collaborates with external lab for testing support.
Supports project management;
-ensures project plan update;
-prepares design document (DHF, DMR, input-output matrix etc.)
Knowledge, education, experience, capabilities and abilities:
- Minimum of 5 years of experience in the medical field
- Familiar with standard reference for Medical Device industries, preferably with business in Class III implantable devices
- ISO 5840 series
- ISO 13485
- Able to manage regulated environments
- CAD expertise (Solidworks)
- Base of statistic for experimental result analysis and experimental sampling plan definition.
- Familiar with lab instruments and inspection methods.
- Familiar with SEM
- Familiar with MS Project or equivalent PM tools
- Fluency in English is mandatory
The position is full-time, based in Northern Italy (relocation assistance is negotiable).
Open position: Product Development Engineer, US
We are looking for a Product Development Engineer, who will support R&D efforts as directed by the Sr. Director for a Trans-Septal Mitral Valve Delivery System.
Tasks include assisting with preparation of the dFMEA, DIR, Design Verification test methods, and establishment of risk-based objective criteria for challenging the test devices in Design Verification and Design Validation. Additionally, the Product Development Engineer will assist with mechanical design, development, and detailing of catheter-based solutions to support refinement of the delivery system through working with partners for prototyping and testing activities. In short, this role can be viewed as primarily a design engineering with quality engineering experience, focusing on risk-based specification development and documentation as well as basic mechanical design and development support.
The ideal candidate will have 5+ years of related cardiovascular catheter engineering experience, although general medical device experience will be considered.
- Engineering or related biomedical degree
- 5+ years of medical device development experience (cardiovascular experience preferred)
- Experience developing dFMEAs, DIRs, Test Methods and Test Method Validations
- Ability to work in a start-up environment (self-starter, motivated, hands-on, small team collaboration)
Please send your application and resume to email@example.com.
“It doesn’t make sense to hire smart people and then tell them what to do;
we hire smart people so they can tell us what to do.”