Staff Systems Engineer

***New Permanent Role – Staff Systems Engineer***
Location – Andover, Massachusetts
Salary – $165k – $180k & Benefits Package
Industry – Medical Device

My client is one of the largest pure-play diabetes care companies in the world, leveraging its nearly 100-year legacy in insulin delivery to empower people with diabetes to live their best life through innovative solutions, partnerships, and the passion of more than 2,000 employees around the globe.

RESPONSIBILITIES:

• Define and drive system-level requirements and architectural decisions.
• Communicate with users, scientists, and customer-facing associates like marketing and field service associates to finesse the customer experience.
• Develop system and subsystem requirements. Play an essential role in Risk Analysis and Risk Management.
• Develop and execute formal and informal test protocols. Use finding to drive decision-making and iterate on the design.
• Utilize modelling tools to simulate and analyse systems, subsystems, and data.
• Communicate requirements and results with the cross-functional teams.
• Provide technical expertise to the Systems Engineering Team and cross-functional project teams to support development and submission objectives.
• Contribute to best-in-class systems engineering functional excellence, including data-driven approach with focus on superior user experience.
• Participate in Design and Technical Reviews to ensure sound decision making is made across the program.
• Establish criteria and methodologies for verification and validation of CTQs and all product requirements,
• Write protocols and reports for integrated system verification and validation testing,
• Support the commercial launch of the system including product surveillance and support.
• Work with process improvement groups to establish effective work products and processes for Systems Engineering deliverables and standardize these across all new product development efforts.
• Promote the Systems engineering function and serve as a driver for the application of a systems-oriented focus to all Diabetes Care development teams and partners.
• As required, serve as a resource within the R&D organization to:
• Analyse, critique and make technical contributions to projects across the breadth of the organization. Supply critical organizational, analysis and problem-solving skills to all aspects of our development programs,
• Coordinate and manage complex technical development activities involving cross-functional teams working within and external to the BD organization,
• Serve as a continued customer advocate.

EXPERIENCE & EDUCATION:

• Minimum of a bachelor’s degree in an engineering discipline, e.g. System Engineering, Mechatronics Engineering, Electrical Engineering, Software Engineering, Computer Science, Biomedical Engineering, or a closely related technical degree is required. Graduate degree in these fields desired.
• 8+ years of hands-on experience in embedded system development is highly desired.
• 8+ years of hands-on experience in one or more areas related to drug delivery, or connected medical devices such as signal processing, embedded systems, electronics, software, and/or cybersecurity strongly preferred.
• Experience in experimental techniques, statistical analysis & engineering investigation techniques.
• Experience with firmware and real-time embedded system development and design principles is required.
• Experience with electrical hardware development and design principles is required.
• Experience in a regulated environment is preferred.
• Familiar working with external contract design and manufacturing facilities.
• Familiarity with regulations and compliance testing is desired.
• Familiarity with requirement management tools and principals is required.
• Experience working with engineering and other professionals in a cross-functional matrix organization is required.
• Demonstrated experience in working on projects at various stages from concept through commercial launch is preferred.
• Demonstrated technical contributions to a project or product in at least one technical discipline is required; multiple disciplines are a preferred.

The ideal candidate should have an EE/FW background as an embedded system engineer who can help make prototypes, teardowns, and help set up requirements for new product development projects.