Be an early applicantLess than 25 applicants

Company

Insulet Corporation · 2 hours ago

Senior Systems Engineer (Remote / Flexible)

SD Metro Area

Full-time

Remote

Senior Level, Lead/Staff

$102K/yr - $153K/yr

8+ years exp

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Health CareMedical

Comp. & Benefits

H1B Sponsor Likely

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Responsibilities

Serve as a key member of a cross-functional project team consisting of electrical, software, mechanical, manufacturing, and quality engineers to achieve project deliverables

Lead system definition tasks such as generating user needs, product requirements, and use-case descriptions

Contribute to system development by defining system and subsystem architectures

Identify and document system hazards, failure modes, and risk mitigations

Work with the technical centers of excellence domain subject matter experts, and suppliers in the assessment, selection, integration, and qualification of key components and subsystems

Serve as technical consulting resource for integration, subsystem and system verification activities creating plans, protocols and reports as necessary.

Create and maintain traceability among design input, design output, verification and validation, and risk management artifacts to ensure completeness and fully traceable design history file.

Support the preparation of proposals, project plans and estimates, and present information and status to leadership and other stakeholders.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Systems EngineeringRequirements ManagementHazardsRisk AssessmentsMedical Device RegulationsCross-functional Team LeadershipElectrical EngineeringDesign Trade-off AnalysisVerification PlansFDA RegulationsSystem ArchitectureMechanical EngineeringBiomedical EngineeringQuality Management System (QMS)Reliability EngineeringProject Management

Required

Bachelor of Science or equivalent degree in Systems Engineering, Electrical Engineering, Mechanical Engineering, Computer Science or Biomedical Engineering is required.

A minimum of 8 years’ experience working as a Systems Engineer or with systems engineering Responsibilities: in a multidisciplinary project team environment.

2+ years of experience in leading a cross-functional development team.

Domain expertise in one of more associated domains; preferably Electrical or Software Engineering, with exposure to Mechanical, Quality, and Test Engineering.

Demonstrated expertise in Systems Engineering practices such as requirements management, design trade-off and cost-benefit analysis, hazards and risk assessments.

Experience writing verification plans, protocols and reports in a regulated industry.

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 experts.

Preferred

Master of Science degree is desired; System Engineering training and/or certification is a plus.

Experience or formal training in established Systems Engineering concepts.

Experience in Reliability Engineering practices such as reliability modeling, prediction, HALT and HASS.

Demonstrated skills in developing and introducing innovative FDA regulated medical devices in the drug delivery market.

Company

Insulet Corporation

Glassdoor

4.0

Insulet Corporation, headquartered in Massachusetts, is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform.

Founded in 2000

Acton, Massachusetts, USA

1,001-5,000 employees

https://www.insulet.com

H1B Sponsorship

Insulet Corporation has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

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Trends of Total Sponsorships

2023 (14)

2022 (29)

2021 (46)

2020 (17)