Quality Engineering role working to bring to market and support novel biomagnetic medical devices. Responsible for engaging and directing cross-functional engineers to support both design/development and post-market activities. Shall work with a quality team to develop documentation, oversee testing activities, and take part in risk management efforts to support regulatory clearances and quality audits. Will be responsible for ensuring that new or modified products conform to medical device quality standards. Build and maintain processes at the company in line with ISO 13485/14971 and other applicable standards, and help develop a rapidly evolving quality management system
Duties and Responsibilities include the following. Other duties may be assigned:
1. Works cross-functionally to provide product quality requirements and quality standards to assess and potentially redefine or clarify system development activities, requirements, Use-Conditions and risks for the development Genetesis devices
2. Partner with and provide quality oversight of both internal and external design/development teams (software and hardware) and approved manufacturing partners
3. Responsible for the assessment of technical standards against current DHF, labeling and technical file requirements.
4. Apply Design for Reliability and Manufacturability tools and techniques to the project as appropriate.
5. Provide effective support for multiple projects in multiple disciplines, balancing priorities and resources appropriately to meet both project and management expectations.
6. Prepare or direct the preparation and/or edit of reports as required by the project.
7. Create risk management plans, perform product risk assessments, facilitate the failure mode effects analysis, and create a final risk management report.
8. Oversee and ensure cGMP regulatory compliance to all applicable medical devices regulatory agencies (i.e. FDA, IMB, Notified bodies, etc.);
9. Provide training to project teams on procedures, statistical methods and design controls;
10. Assist in the creation and execution of verification, validation protocols, Design History Files and Technical files for conformance to applicable requirements;
11. Work adaptively in a fast-paced small team environment with aggressive deadlines
12. Travel to offsite locations as required for training and site deployments
● Bachelor level degree or above in Engineering (Mechanical or related)
● 1-5 years of experience in a degree-related quality assurance or development support role, ideally with both hardware and software.
● Experience with design controls and documentation, test method development and validation, test execution, failure analysis and risk management; Preferably with both hardware and software.
● Excellent Proficiency with quality systems and standards compliance (ISO 13485, FDA 21 CFR 820, ISO 14971, ANSI/IEC 62304 etc.)
● Excellent verbal and written analytical/problem solving, communication, negotiation, interpersonal and presentation skills Project management and leadership skills, including the demonstrated ability to lead multi-departmental teams
● High level proficiency with Microsoft Office
● Quality Management Systems