Staff Systems Engineer
- Job Type:
- IT leadership
- $165k – $180k
- Ref #:
***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.
- 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.