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: Quality Manager/ Head of Quality, US

We are seeking to hire a Quality Manager to lead all Quality responsibilities at the US Site. This role will will coordinate efforts with resources based in the US Site and the Company Headquarters, reporting to the Vice President of Quality in Italy.

 

Responsibilities

  • Responsible for the site maintenance of the Quality Management System in compliance with the FDA Quality System Regulation 21CFR Part 820 and the ISO 13485:2016 International Standard.
  • Interface with vendors on quality aspects of the supplies and conducts supplier audits and qualifications.
  • Ensures the design and development of the trans-septal delivery system ensures safety, efficacy, compliance and traceability.
  • Lead the completion and maintenance of Risk Management requirements and Usability activities during development of the trans-septal delivery system.
  • Train and provide support and guidance to the site staff to implement the QMS processes and procedures, with special focus on the Design Control process and procedures and records traceability.
  • Review and approval of product design and process verification and validation activities and measure readiness throughout the product development cycle including capability assessments and supplier qualifications.
  • Oversee inspection of incoming and in process inspection materials, ensuring that they meet requirements.
  • Responsibility for final acceptance activities and product release, including authority to sign Declarations / Certificates of Conformity
  • Manage the monitoring, measurement, and review of internal processes, especially those that affect the quality of the organization’s products.
  • Responsible for accuracy and timely inspection / calibration of monitoring and measuring devices.
  • Oversight of the calibration and equipment maintenance program.
  • Root cause investigation and implementation of corrective and preventive actions.
  • Report to top management on the performance of the QMS (e.g., suppliers’ performance, results of quality audits, corrective actions), including the need for improvement.

Experience Needed

  • Minimum 6 years experience in Quality Assurance or Quality Engineering in Medical Device industry
  • Bachelor’s degree or higher in an engineering discipline
  • Knowledgeable of regulatory requirements of Medical Devices
  • Experience or maturity to hire QA team
  • Able to leverage structured problem solving methodologies to root cause and resolve quality issues. Certified Quality Engineer, Six Sigma certification or equivalent highly desired.
  • Design and Development experience as the Quality lead role in a cross-functional medical device design and development team
  • Familiarity with Class III medical device clinical & regulatory pathway
  • QMS development, maintenance, and audit-hosting experience for ISO 13485 requirements
  • Supplier management and auditing experience
  • Travel to US suppliers and Italian site (~15% travel)
  • Startup mentality
  • Catheter manufacturing experience is desired
  • Structural Heart or related cardiovascular experience is desired

 

The position is full-time, based in Newton, MA (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.

 

Responsibilities

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.

The ideal candidate will have 5+ years of related cardiovascular catheter engineering experience, although general medical device experience will be considered.

 

Requirements

  • 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)
 The position is full-time, based in Newton, MA.

Open position: Sr. Design Engineer, US

We are looking for a Sr. Design Engineer, who will support R&D efforts as directed by the Sr. Director for a Trans-Septal Mitral Valve Delivery System.

 

Responsibilities

Tasks include assisting with design and development of steerable and passive catheters as well as the development of the procedures for use of these catheters, as well as test fixture design and assistance with Design Verification testing. Experience with Solidworks modeling, 3D printing and prototyping is a requirement. Additionally, the Sr. Design Engineer will assist with detailing of catheter-based solutions to support refinement of the delivery system.

 

Requirements

  • Engineering or related biomedical degree
  • 5+ years of medical device development experience (cardiovascular experience preferred)
  • Experience developing and prototyping cardiac catheters
  • Proficient in Solidworks, 3D printing, prototyping, testing and refining concepts
  • Ability to work in a start-up environment (self-starter, motivated, hands-on, small team collaboration)

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

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