Senior Systems Engineer

Job Description

The Senior Systems Engineer is responsible for the risk management (RM), design and requirements specification, usability engineering, and compliance engineering of medical electrical systems used in Neurology, Audiology, and Newborn Care products. You can expect to be involved in all phases of the product lifecycle, for both new product introductions and maintenance of existing products. This role entails a special focus on RM for post-market activities. In this job, you will: Stay up-to-date and follow all Quality System procedures related to this job, which can affect the quality of products or services provided to our customers Execute risk analysis activities using FTAs, FMEAs and similar tools Analyze production and post-market data to identify changes to product risk Apply ISO 13485, ISO 14971, US FDA Quality System Regulations (21 CFR 820), EU MDR and relevant international standards to systems engineering group Participate in developing design controls procedures for application to legacy products and new product development Identify and maintain traceability between risk control measures and product requirements and verification / validation Take guidance from the lead risk management engineer for risk management responsibilities and improvements Coordinate activities with contributors from regulatory and quality affairs, clinical, marketing, and cross-functional engineering disciplines Participate in quality improvement, complaints investigation, change control, and safety assessment processes Contribute to harmonizing the company s various medical device platforms by converging system architecture and reusing components as well as design and test practices (product line engineering), specifically related to risk analysis Travel: up to 25% domestic or international travel Qualifications: Bachelor s degree in Engineering or Science; Master s degree is an asset Minimum 7 years systems engineering relevant experience and/or training 5+ years experience in the medical device industry working with applicable quality and safety standards, and regulations Experience with risk management process and tools; requirements specification and traceability Experience with CAPAs and DHF remediation for legacy products Demonstrated ability to deal with a fast-paced environment, high levels of ambiguity, multiple concurrent projects, and conflicting assignments Experience with project management a plus.