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Title Director of Systems Engineering

Hiring Organization: Connexion Systems & Engineering

• Duration: Perm
• Pay rate: 185k
• Job Location: Acton, MA
• Job# 14520

Director of Systems Engineering

Job Summary

1. Director of Systems engineering is responsible for the overall direction, budget and strategy for the Systems Engineering Team with respect to people, process, engineering content and design tools. The Director and their team own the system level design, requirements, reliability and test engineering for capital equipment and associated disposable medical devices. The Director will build on extensive hands-on experience in capital systems development and a deep understanding of technical, end user and patient needs to ensure that systems designs and associated requirements drive project teams to achieve best-in-class medical products. This role is a key leadership position in the R&D team and will strive to recruit and retain a highly capable, collaborative and diverse team of systems engineers. The Systems Team will interact with all areas of the business to ensure timely development of new products and exceptional support of existing designs.

Essential Duties and Responsibilities

The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.

• Overall leadership of the Systems Engineering Team to ensure on-time, on-budget delivery of project objectives with representation to the R&D Leadership Team for the Systems function
• Staffing and people leadership of the Systems team to ensure consistent capability, capacity and growth of the people and their domain expertise and execution
• Working closely with cross-functional project teams, ensure consistent delivery of Systems activities across system design, requirements definition/management, risk management, test (V&V) and reliability
• Work across commercial, technical and regulatory functions to ensure comprehensive understanding of customer/patient/technology/business needs and clear translation into system requirements
• Collaborate with hardware, software, electrical, optical and mechanical design teams on system designs to ensure that all requirements are met before and after system integration
• Support key process deliverables including User Needs Document, Product Requirement spec, traceability, system architecture, FMEA, system verification and validation, and ongoing technical support to operations and service
• Collaborative and hands-on support of project deliverables for quality, regulatory and sustaining to ensure business continuity
• Educate and mentor the R&D and broader organization on systems engineering best practice
• Monitor and ensure both compliance with and documentation of compliance with policies and procedures as outlined in various Company policies, including the Global Approval Authority Matrix and other mandatory policies pursuant to one’s job description.
• Embody and deliver the “Exceptional Everyday”

Qualifications (Select the minimum qualifications required for this position to successfully achieve business requirements)

Education

Bachelor’s degree required

Master’s degree preferred

Specific Area of Study: B.S. in Electrical, Biomedical, Computer Science or related engineering discipline.

Experience

12+ years relevant experience

Specific Related Experience: Systems engineering in product development, new product introduction and on-market product support.

Skills

• Passion for delivering best-in-class products to market that exceed customer expectations
• Strong leadership skills to both develop and grow a systems team as well as represent their work to the broader organization
• Mastery of the product development process, design controls, requirements and test (V&V)
• Core competency in RF and/or optomechanical system design and test
• Broad experience in capital systems design with a track record of successful product launch
• Demonstrated cross-functional team leadership and interdepartmental collaboration.
• 5+ yrs experience in a regulated field such as medical device or aerospace/defense
• Knowledge of global medical design standards (FDA, ISO, Int’l)
• Working knowledge of project management, requirements management, board layout and mechanical design software.

Physical Demands

The physical requirements described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

• Sit; use hands to finger, handle or feel objects, tools, or controls.
• Stand; walk; reach with hands and arms; and stoop, kneel, crouch, or crawl

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