Senior Staff Software Systems Engineer

Job Type:
Perm
Sector:
IT leadership
Location:
USA
Salary:
$190k – $200k
Ref #:
A000848

**New Permanent Role – Senior Staff Software Systems Engineer**

Location – Massachusetts – United States
Salary $165k - $180k & Benefits Package
Industry – Medical Device

 

Job Description Summary

 

The Sr. Staff Software Systems Engineer will be a technical lead in the design and development of diabetes products. The candidate will function within a group that acts as the hub of product development within the R&D organisation. This position entails leading systems engineering activities within new product development projects.

This role involves utilising technical knowledge, engineering tools, and methodologies to define and connect pieces across different functional elements (Software, Firmware, Electrical, etc.) within a regulated environment. The successful candidate will have an exciting opportunity to contribute to the company’s R&D organisation tied to developing a new business platform for Diabetes Care.

*PLEASE NOTE - This position is in Andover, MA. If outside of the area, relocation would be necessary.

 

 

RESPONSIBILITIES:

  • Key member of a multi-functional project team consisting of Software, Firmware, Electrical, Mechanical, Manufacturing, and Quality engineers alongside Marketing, Medical, and Regulatory partners to achieve project work.
  • Lead system definition tasks such as generating user needs, product requirements, use-case descriptions, and architectures.
  • Lead discussions with software and firmware teams to define communication protocols and message sequencing for functions that rely on wireless communication between subsystems
  • Participate in system and software safety risk analysis and risk control identification.
  • Connect with users, scientists, and customer-facing associates like marketing and field service associates to finesse the customer experience.
  • Develop and implement formal and informal test protocols. Use findings to drive decision-making and iterate on the design.
  • Apply modelling tools to simulate and analyse systems, subsystems, and data.
  • Communicate requirements and analysis results with multi-functional teams.
  • Contribute to best-in-class systems engineering functional excellence, including a data-driven approach focusing on outstanding user experience.
  • Participate in design and technical reviews to ensure sound decision-making across programs.
  • Establish criteria and methodologies for verification and validation of product requirements.
  • Write protocols and reports for coordinated 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 and standardise 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 the need arises, serve as a resource within the R&D organisation to:
  • Analyse, critique and make technical contributions to projects across the organisation’s breadth. Supply critical organisational, analysis and problem-solving skills to all aspects of our development programs.
  • Coordinate and lead sophisticated technical development activities involving multi-functional teams working within and external to the organisation.
  • Serve as a continued customer advocate.

 

 

EXPERIENCE & EDUCATION:

  • Minimum a bachelor’s degree in System Engineering, Software Engineering, Computer Science, Computer Engineering, Mechatronics Engineering, Electrical Engineering, Biomedical Engineering, or a closely related technical degree is required. Graduate degrees in these fields are preferred.
  • 8+ years of experience working as a Systems Engineer or with Systems Engineering Responsibilities: in a multidisciplinary project team environment is required.
  • 10+ years of experience with firmware and real-time embedded system development and design principles is required.
  • 10+ years of experience with wireless communication techniques such as Bluetooth, Zigbee, and Wi-Fi are required.
  • 2+ years of experience in leading a cross-functional development team is required.
  • Experience with electrical hardware development and design principles is required.
  • Hands-on experience in one or more fields in Connected Medical Devices, Wireless Body Area Networks (WBAN), Wearable Electronic Products, and Cloud Connected Devices is highly desired.
  • Proficient with Medical Device regulations (ISO 13485, ISO 14971, IEC 62304, 21 CFR part 820.30-Design Controls).
  • Excellent project team skills: experience and capability working collaboratively under a Quality Management System (QMS) as part of a cross-functional team that includes development, verification/validation, manufacturing, marketing, clinical, regulatory and quality authorities.
  • Confirmed expertise in Systems Engineering practices such as requirements management, design trade-off and cost-benefit analysis, and hazards and risk assessments are required.
  • Domain expertise in one or more associated domains, preferably Electrical or Software Engineering, with exposure to Mechanical, Quality, and Test Engineering, is required.
  • Experience in experimental techniques, statistical analysis & engineering investigation techniques is highly desired.
  • Validated experience working on projects at different stages from concept through commercial launch is highly desired.

 

KNOWLEDGE, SKILLS, AND ABILITIES:

  • Strong problem-solving and troubleshooting skills.
  • Must be a self-starter.
  • Strong technical leadership and interpersonal communication skills.
  • Excellent oral, written, and presentation skills.
  • Ability to work successfully in cross-functional teams.

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