We are totally focused on the development and commercialization of solutions that improve the way complex cardiac arrhythmias are diagnosed and treated. Our passionate, driven team of innovative professionals are dedicated to providing better tools for clinicians and making life better for the millions of people who suffer from these challenging conditions around the world. Are you ready to be a part of a dynamic, innovative team with a shared purpose that truly matters? If so, we are currently looking for a Senior Engineer - Quality to join us in our important mission.
The Senior Engineer - Quality will support Quality Assurance, R&D, Manufacturing Engineering, and Operations in the design and manufacture of disposable medical catheters, in compliance with applicable regulatory and statutory requirements, including but not limited to 21 CFR 820 (Quality System Requirements), EN ISO 13485:2016, EN ISO 14971:2012, and CGMP.
The Engineer will also assist with design controls, design transfer, and design change of cardiac electrophysiology catheters and will work with engineers from R&D and manufacturing engineering to plan, perform, and test the processes required to convert R&D prototypes and processes into pilot production at the facility. While the position will require hands-on work, it is expected that the incumbent will always be imbedded in a cross-functional, product-centric team. Will ensure that the contents of Design History Files, Device Master Records, and Device History Records are accurately developed, that the designs are properly verified, and that manufacturing processes are validated or verified as needed, in accordance with the Company requirements, regulatory requirements, and guidelines. The Principal Engineer - Quality may supervise junior engineers or technicians.
Duties And Responsibilities
* Represents Quality Assurance during the Design Control and Design Review process through review and approval of the applicable Design Input, Design Output, Design Verification, Validation, and Design Transfer.
* Performs planning, testing, qualifications, and release of design change to released products, as required during the life cycle of commercialized devices.
* Performs and/or reviews product acceptance testing; reviews and approves test results; creates, reviews, and approves device history records.
* Assists with the definition and deployment of downstream processes, such as field service procedures, evaluation of spares, and investigation of product returns.
* Is a driver of change and decision-making within the department; contributions are essential to the overall company's objectives.
* Supports all company internal and external audit functions and coordinate activities of third party audits /visits.
* Supports activities related to Management Review, CAPA, Nonconforming materials, Process Deviations, Complaints, Product Field Actions, internal and external audits, and related document control functions.
* Builds consensus and gains support of key stakeholders. Coordinates across and within the organization to determine the appropriate resources and budget to complete projects in the most-efficient manner. Is a driver of change and decision-making within the department; contributions are essential to the overall company's objectives. Ensures a high degree of quality in the department's work. Demonstrates Company-wide influence and technical competence, particularly in the languages and techniques used in engineering.
* Participates in and has ability to lead highly effective teams or design effort. Is responsible for providing work direction and professional development to a research team. Is an equitable and respectful leader. May be responsible for direct reports. People management responsibilities may include hiring / terminations, performance reviews, career development coaching and compensation decisions.
* Is responsible for compliance with quality system procedures and all regulatory requirements.
* Consistently promotes collaboration, positivity, accountability and resourcefulness.
* Must demonstrate mutual respect, ongoing communication and a positive outlook with both internal team members and customers.
* Typically requires a minimum of 6 years of related experience and a Bachelor's and/or Master's degree, in a scientific/engineering discipline; or equivalent combination of education and experience.
* Experience in catheter design and production, or with similar medical devices, while working within Quality is required.
* Applied understanding of 21 CFR 820, EN ISO 13485:2016, ISO 14971:2012
* Demonstrated expertise in Process Validation, Product Validation, and Statistical Methods.
* Demonstrates technical expertise and implementing innovative solutions. Regularly collaborates with others and provides independent thought in suggesting and influencing design and research strategies. Works on complex problems in which analysis of situations or data requires an in-depth evaluation and may impact future concepts and technology. May be required to actively contribute to regulatory filings, patent applications and other industry related publications. Demonstrates high level of strategic and global thinking.
* Must be able to understand job duties and responsibilities, have the necessary skills/knowledge and be willing and able to continue learning and growing within the field.
* Must be skilled at managing a significant workload and obtaining positive results, taking on additional responsibility and managing priorities as needed.
* Must be accurate, detailed, committed to high quality standards and pro-active in finding solutions to achieve successful outcomes.
* Strong verbal and written communication skills with the ability to produce accurate, punctual reports/information, as required and thoroughly share information with others. Must be able to read, write and speak effectively.
* Exceptional listening skills with the ability to seek constructive feedback, build relationships, promote teamwork and remain flexible and open-minded. Able to quickly adapt to change.
* Capable of following realistic plans, goal setting, resource management, contingency planning, coordinating and cooperating with others.
* Capable of working thoughtfully under pressure and in a timely manner.