Senior/Staff Quality Engineer - Design Controls
We are 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.
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 embedded 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 Senior 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.
- Works independently, but contribution's impact the overall team's objectives. Influences some of the overall project goals. Is a collaborative team player and demonstrates open-mindedness and flexibility. Creates innovative and creative solutions to keep projects on-track and to determine the best practice for new assignments. Pays particular attention to existing resources and makes recommendations for efficiency. Maintains a high degree of quality in all work performed. Demonstrates small team influence and technical competence, particularly in the languages and techniques used in engineering.
- By way of example, sets a precedent for being a positive team member. Is a resource for cross-functional informational sharing. May provide project work guidance or technical feedback to other engineers. May help mentor newer team members, who are learning new skills. May be responsible for a functional area or contracted / outsourced employees or matrixed reports and not have any direct reports within the organization.
- Is responsible for compliance with quality system procedures and all regulatory requirements.
- 5+ 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
- Experience and familiarity with Biocompatibility and Sterilization processes & standards.
- Demonstrated experience in Design Controls and Risk Analysis.
- Demonstrated expertise in Process Validation, Product Validation, and Statistical Methods.
- Consistently demonstrates technical proficiency and developing innovative solutions. Anticipates and provides solutions for obstacles and challenges. Regularly collaborates with others in suggesting valuable solutions. Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgement within broadly defined practices in selecting methods, techniques and criteria for obtaining results. Collaborates cross-functionally, may lead a team or project.