Careers at InnovHeart

We have open positions. Apply now!

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.
This position will be reporting to the Sr. Director R&D, Italy at the Colleretto site.

 

Responsibilities

Collaborate in the development and manufacture of implantable devices and their accessories. Convert design inputs and customer requirements into a functional design for the realization of an implantable device. Develop the design of the device in order to make it producible thanks to the available technologies. Coordinate the activities necessary for the realization of the prototypes. Support design verification and design validation activities. Collaborate in defining test and verification methods for the device and its components. Define specifications and user requirements for test equipment and machines. Management, selection and technical support to suppliers. Collaborate in the development and implementation of internal manufacturing, assembly and inspection processes. Define and develop the documentation necessary for the production of equipment and machines for the process (drawings and specifications). Create and keep up-to-date the project documentation in accordance with the requirements of the QA procedures and the quality manual. Generate the relevant documentation for creating the DHR for the device. Generate project support DHF documentation. Collaborate in the creation of the design outputs and the drafting of the design matrix.

 

Requirements

  • Engineering or related biomedical degree
  • 5+ years of medical device development experience (cardiovascular experience preferred)
  • Familiarity with standard reference for Medical Device industries, preferably with business in Class III implantable devices;
  • Ability to work in a highly regulated environment;
  • Fluency in English.

Open position: Sr. Regulatory Affairs Specialist, US

Responsible for Regulatory Affairs activities to lead regulatory submissions, registrations, listings and annual reports. Ensure compliance with applicable medical device regulations per jurisdiction, guidance and standards. Creation and maintenance of regulatory files.
This position will be reporting to the VP Clinical and it will be based mostly at the Newton (MA) site.

 

Responsibilities

  • Stay abreast of regulatory requirements, procedures and latest changes in regulatory climate to allow a thorough gathering of the applicable regulatory requirements and input to the QMS and the design and development Team.
  • Review and support the design and development activities e.g. the preparation of product labeling including instruction for use and training material for compliance with applicable regulations and technical standards.
  • Write, edit and analyze technical documents to support country-specific regulatory submissions and compile submissions in a format consistent with applicable guidance documents, including investigational device submissions in USA, Europe and China through the local legal agent. Work with other departments and communicate the submission requirements when documents are needed for regulatory submissions.
  • Maintain regulatory files. Maintain and update regulatory authorizations, such as IDEs, submissions and follow-up with National Competent Authorities (NCAs) in Europe and support the establishment and maintenance of the Medical Device Technical documentation in view of the conformity assessment or approval in different geographies.
  • Prepare responses to regulatory authority questions within assigned timelines.
  • Support the assessment of device deficiencies of investigational devices employed in clinical investigations. Compile and submit reportable events to relevant regulatory authorities in timely manner.
  • Support external regulatory agency audits, providing regulatory input to minimize potential for findings of non-compliance.
  • Other duties as assigned


Qualifications

  • 3-5 years of previous medical device regulatory affairs experience required
  • Minimum of 1 year experience working at a structural heart company a plus
  • Bachelor’s degree or country equivalent in Engineering or Science or related scientific discipline, or equivalent. Higher degree/PhD a plus.
  • Scientific knowledge, must be able to digest complex data while keeping the big picture through good analytical skills
  • English language excellent written and verbal communication skills with the ability to listen, articulate and advocate
  • Proactive, high performance, result oriented and ability to manage multiple projects and deadlines
  • Technical system skills (e.g. databases, efficient online research)
  • Ability to identify compliance risks and escalate when necessary
  • Demonstrate both creative and critical thinking skills.

Please send your application and resume to info@innovheart.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.”

Steve Jobs