Job description
Role Overview:
The R&D Staff Systems Engineer in the Advanced Wound Management (AWM) business will drive and lead system engineering for new product development (NPD). The role will work with the R&D Director of AWM Software Development and Digitally Enabled Products. The successful candidate will bring a demonstrated track record of driving innovation that delivers products to the market and a team player mentality to help the team deliver complex digital product solutions.
Responsibilities:
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Drive all the engineering activities and technical aspects of the program in partnership with the technical leads and/or other Systems Engineering leads
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Clearly articulate program mission and characterize partners
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Own requirements development for the program, including drafting of User Needs and Design Inputs
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Define system architecture – including functional, physical and interface requirement specifications
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Develop verification and validation strategy for sophisticated medical systems
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Support pre-clinical and clinical evaluations
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Support system integration builds
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Remain current with the knowledge and practice of systems engineering and requirements management
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Analyze complexity and handle risk
Location:
Andover, MA
Education:
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Minimum BS degree in Computer Science, Computer Engineering, Electrical Engineering or related technical field
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Preferred MS degree in Engineering or in a related field
Certifications/Licenses:
INCOSE training and certification is a plus
Experience:
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6+ years of related experience with a BS degree
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3+ Years of related experience with an MS degree
Competencies:
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Consistent track record of delivering innovate medical device products to the market
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Solid understanding of systems engineering process and quality systems
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In-depth knowledge in at least one subject area: software or electrical engineering
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Has brought first-of-its-kind solutions to the marketplace
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Expertise in partitioning and decomposing complex engineering problems into solvable problems
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Experience working with agile development methodologies and exposure to working within CI/CD
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Skilled in writing requirements and strategizing verification and validation plans
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Detailed understanding of IEC 62304, ISO 14971, IEC 60601, FDA and MDR design control requirements for medical devices
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Experience using Cognition Cockpit or similar tools for requirements management
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Experience using Enterprise Architect or similar tools for model-based systems engineering related activities
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Persistent, driven, self-motivated, keen to make an impact
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Excellent organizational, documentation and written/verbal communication skills
Travel:
10%
Smith+Nephew provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.
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