Our team is all about building the future of the operating room for Urologists.
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 Principle Systems 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 establish and maintain MEE / MES in partnership with the greatest minds in the entire medical device industry. 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 Urology Division.
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 DA SME and work with Product Development Engineers (embedded within R&D) to review Hardware/Software systems architecture(s) and identify possible failure modes/risk control opportunities for these complex systems.
Lead risk-analysis activities through coordinating 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 maintain risk management and usability activities.
Lead or support development of NPD Reliability Engineering Program Plans and related reliability program activities
May perform other duties as directed
Requirements: 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, EUMDR, IEC 60601 and EN ISO.
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%
This position is open to all candidates.
