The Senior Systems Engineer position is a key technical leadership role and has responsibility for the design ownership of a single product over the full lifecycle.  In this role, the System Engineer will integrate multi-disciplinary inputs and outputs to support the definition and development of complex software controlled electro-mechanical medical device products.  As design owner of a medical device, you are responsible for ensuring that your device is built in accordance with customer, business and regulatory requirements.  This is done by effectively translating product requirements to design outputs, managing technical risks of the product, and following the technology roadmap.  This position typically overlaps many technical and human-centered disciplines, including industrial engineering, functional engineering, human factors, security, marketing, regulatory affairs, quality assurance, and project management; a strong candidate will demonstrate a keen ability to facilitate cross-functional collaboration.  The engineer is a key leader in development and management of support activities such as technical planning, systems integration, verification and validation, cost and risk, life-cycle management and effectiveness for total systems.

Company Profile

Client is a small to mid-sized medical device company focused on interventional and diagnostic technology.

Primary Duties and Responsibilities:

• Ensure the logical and systematic translation of user and project needs into a comprehensive set of system and sub-system requirements in collaboration with the technical design leaders.
• Take technical ownership of the product throughout its lifecycle and provide effective technical leadership to the product and engineering teams.
• Resolve technical challenges by providing technical guidance to the product and engineering team through rigorous trade-off analysis to create robust and effective solutions.
• Facilitate cross-functional technical decision making and optimize the balance between technical and schedule risk with the cost targets of the product lifecycle needs.
• Lead the integration of the sub-systems and ensure that the product meets the user and system requirements. Demonstrate the traceability of requirements through Validation and Verification.
• Lead the risk, hazard, and timeline analysis in to quantitatively evaluate design concepts & solutions.
• Plan, coordinate, and manage cross-functional design activities and interface directly with the product leadership team on project issues and status.
• Integrate sound design principles and standards into your programs including Design for Reliability, Manufacturing, and Service.
• Identify user groups, environments, use scenarios and critical tasks for task analysis, instructions, guides, user training and system verification.
• Engage with the test teams to ensure plans for verifications and validation activities are successful.
• Initiate and lead activities such as Failure Modes and Effects Analysis (FMEA) that identify design issues and lead the team in developing mitigations to address these issues.
• Help the team members in developing high-quality documentation for all phases of product development, including design specifications, verification test plans, project schedules, and change orders associated with medical devices.
• Partner with the functional technical leaders (Architects/Principals) to develop significant and impactful Intellectual Property to fuel the growth of the business.
• Perform work in adherence to the company Quality Management System (QMS), including development and maintenance of documentation.
• Develops products that meet requirements regulated by FDA, EU regulatory body, PMDA, and other governing bodies as defined by product management.
• Commit to fostering and driving an environment and work output based on continuous improvement.

Qualifications (Knowledge, Skills & Abilities):

Required:

• Bachelors’ degree in Engineering, or other scientific discipline, preferably electrical, or mechanical
• 7+ years of engineering experience
• 3-5 years new product development and exposure to systems engineering roles
• Demonstrated experience with risk management and systems engineering processes
• Demonstrated ability to clearly and accurately translate needs and requirements
• Ability to grow productive, trusting, and open relationships with a wide variety of constituencies
• Strong interpersonal and communication skills
• High degree of organizational skills and high attention to detail
• Ability to handle multiple tasks and prioritize effectively
• Ability to work both independently and as part of a team
• Ability to develop protocols, conduct system tests and write reports
• Strong initiative and passion about new technologies with high energy

Preferred:

• Graduate degree in Engineering (EE, ME) or another scientific discipline.
• 5+ years systems engineering experience
• Experience working with physicians and customers in a medical device product development role
• Working knowledge of tolerance analysis, and geometric tolerance.
• Awareness and working knowledge of system-level constraints in all disciplines, including mechanical, electrical and software
• Voice-of-customer experience and Fluency with clinical radiology terminology.