SeLux is looking for a versatile, self-motivated, independent and experienced Lead Systems Engineer to provide content, expertise, and leadership in software requirements generation, project milestone reviews, labeling, and consumable development for new products. This role will work within the Product Development team, also working closely with Quality Assurance and Software Engineering.
· Serve as subject matter expert on FDA-compliant labeling and work within R&D team to develop all required product labeling.
· Advise R&D team on consumables development, production, testing, qualification, labeling, packaging, and shipping and help ensure designs meet and are well-covered by requirements.
· Provide technical oversight and leadership in preparing and facilitating design and Phase gate reviews, working closely with Quality Assurance and Program Management to collect input and deliverables to ensure complete review packages.
· Work with Software team (business analyst, architect, developers and SQA) to capture and manage software requirements and conduct software risk assessments.
· Lead, train, and coach others on Design Controls, Risk Management, Labeling and other Regulatory requirements.
· Bachelor’s degree or higher in Engineering discipline (electrical, software, biomedical)
· 7+ years desired of experience in systems engineering of complex electro-mechanical medical devices. Specific In-Vitro Diagnostic (IVD) experience desired.
· Expert knowledge in FDA-compliant (21CFR809.10) labeling design including package inserts, IFUs, product and reagent shipping labels, with specific IVD knowledge
· Expert knowledge of reagent production, stability testing, labeling, shipping, packaging, QC, lot controls, and PFMEAs and ability to design and develop all associated documentation with SME input
· Experience working with software teams and generating testable, implementable software requirements.
· [Desired] Expert knowledge of medical device and software development standards and experience developing a company culture of adherence to them.
· Ability to work creatively and productively across systems and software engineering. Excellent interpersonal, communication, and documentation skills are required.
· Passion about a company that aims to change industry and how healthcare is delivered!
SeLux, a 4.5-year old start-up company in Boston, is building a diagnostic platform to revolutionize Infectious Disease patient care and combat the current antibiotic resistance epidemic. SeLux’s first product, a rapid antibiotic susceptibility test (AST) platform, uniquely breaks the current trade-offs between speed, cost, accuracy, and antibiotic menu breadth that plague the current generations of devices. The 30-person company closed its $25M Series B financing in March ’18 and is on track to obtain FDA clearance in 2020.
SeLux was recently awarded a milestone-based government contract from the Biomedical Advanced Research and Development Authority (BARDA) worth up to $45M to build its second-generation direct-from-sterile sample identification and AST platform. By eliminating most standard microbiological culturing, this platform will enable Infectious Disease clinicians to deliver same-day personalized antibiotic therapies to septic patients and those with urinary tract infections.
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