we are seeking a Senior Design Quality Assurance Engineer for our Urology division. This role involves developing, supporting, and managing risk for Medical Electrical Equipment/Systems (MEE/MES) and related accessories as part of New Product Development. Become part of a team shaping the future of the operating room, with a focus on advanced kidney stone treatments and innovative solutions for physicians and patients. Lead the development of safe, high-quality products and make a direct impact on patient care and clinical outcomes.
Your responsibilities include:
Lead product teams within the BSC Quality System to develop new MEE and MES as part of a core group of DQA Engineers supporting the Laser Therapies franchise. Special focus on:
Engagement with project teams for Systems Engineering and Systems Risk Management as a Subject Matter Expert (SME).
Utilize Systems Engineering practices to lead efforts for requirements management/system architecture to align risk mitigations with design inputs, design outputs at different levels (e.g., system / sub-system) for products that are both stand alone, and network connected.
Lead NPD projects as a DQA SME and work with R&D Product Development Engineers to review Hardware/Software systems architecture(s) and identify possible failure modes/risk control opportunities for these complex systems.
Lead Risk Management activities during all phases of Electrical HW/SW design, using design quality assurance principles applicable to FDA/EUMDR-Regulated Class II Medical Device environments (including interconnected software systems).
Participate and lead in the creation and maintenance of Risk Management and Usability deliverables.
Lead and/or support development of NPD Reliability Engineering Program Plans and related reliability program activities.
May perform other duties as directed.
Requirements: Minimum Qualifications
B.Sc in Biomedical, Electrical Engineering or equivalent.
5+ years of Medical device engineering experience, with experience in Medical Electrical Equipment/Systems (MEE / MES).
Experience with Reliability and Systems Engineering principles
Experienced in working in a regulated environment for example FDA, ISO standards, EUMDR, IEC 60601, EN ISO 14971 and EN ISO 13485.
Strong leadership skills.
Hands on team player.
Coaches others in analysis and decision making. Strong communication and presentation skills.
Competent with use of Microsoft Office Suite, Minitab Statistical Analysis software (or equivalent) and/or other electrical testing/simulation software.
Travel approximately 5-10%.
Preferred Qualifications
Certified Reliability Engineer and/or Systems Engineer
Experience with Software as a Medical Device (SaMD) and/or systems integration
This position is open to all candidates.