Senior Design Quality Engineer

Description

As Senior Design Quality Engineer, you will lead and support Quality activities for R&D, including medical device software development, in accordance with current standards, regulatory requirements and company procedures. You will ensure compliance, product safety and product performance in line with approved specifications, and act as the Quality partner and design control authority for R&D project teams.

The role operates in accordance with the Insightec Quality Policy, relevant Quality Procedures and Standards, and privacy and safety rules.

What you will be doing:

· Lead and support design control activities for R&D projects, with focus on software development projects, from Design Planning through Transfer to Production

· Ensure proper execution of design input, design output, verification and validation stages, including software requirements, architecture, verification and validation, and traceability

· Review and approve R&D and technical documentation, including procedures, protocols and reports, with emphasis on software lifecycle deliverables

· Provide Quality support of software development lifecycle processes in accordance with IEC 62304, including software classification, risk management, anomaly handling, configuration management and release

· Provide Quality support for the validation of software tools used in the QMS and in R&D, including those used for development, testing, requirements and traceability management, and electronic QMS, in accordance with ISO 13485 and FDA guidance

· Ensure usability engineering, cybersecurity and software risk management activities are integrated into design controls and risk management files

· Support change control for R&D-related products and Life Cycle Management products, including software changes and releases

· Review and approve Quality-related procedures and documentation

· Support annual quality plan activities, Management Review, quality metrics and QA compliance KPIs

· Lead internal audits and participate in external audits

· Supporting the Complaints handling process activities as the design control point of contact

· Operate within the framework of medical devices industry standards such as ISO 13485, FDA 21 CFR 820 (QMSR), MDSAP, EU MDR, ISO 14971 and IEC 62304.

Requirements

· Bachelor’s degree in engineering, science or technical field or equivalent, Master's degree preferred.

· Minimum 7 years of experience in the highly regulated multidisciplinary medical device industry in Quality, R&D or Regulatory roles with direct responsibility for Design Controls.

· Proven hands-on experience in medical device R&D environments, working closely with multidisciplinary development teams (software, hardware, systems and clinical) throughout the product development lifecycle.

· Experience in medical device software quality, including Software as a Medical Device (SaMD), covering the software development lifecycle, software verification and validation.

· Experience supporting software tools validation in a regulated environment (e.g. risk-based computer software assurance (CSA) and 21 CFR Part 11 / electronic records and signatures).

· Strong knowledge of Quality Management Systems, Design Controls, GMP, Risk Management, Internal Audits, CAPA, Change Control and Documentation Controls.

· Working experience with applicable regulations and standards (including, but not limited to): ISO13485:2016, FDA 21 CFR 820 (QMSR), EU MDR, MDSAP, ISO 14971, IEC 62304 and IEC 62366-1.

· Ability to transfer technical expertise by teaching, developing and mentoring employees.

· Process detailed & results oriented.

· Ability to work in a fast-paced environment team and in line with the company’s values.

· Well organized, with the ability to deliver results on several projects simultaneously.

· Strong oral and written communication skills.

· Professional level of English.

Advantages:

· Experience in regulated high-risk-class medical devices (e.g. FDA Class II/III, EU MDR Class IIb/III) and with IEC 62304 Class B/C software.

· CQE or CQM or equivalent certification

· Certified Lead/Internal Auditor