As the industry leader in surgical kidney stone treatment, we are on a mission to empower physicians to treat more cases, more efficiently, with better outcomes; To help patients in need get back to their daily lives. As a Principal Design Quality Assurance (DQA) Engineer, youll be at the heart of that mission to develop and support best-in-class products to bring advanced, safe innovations to the clinic. You will also be leading the effort to develop MEE / MES. Your contributions will directly impact patient care at a company widely regarded as being a quality leader in the medical device industry.
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.
7-8 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.