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systems engineer
Randstad US • Remote • Posted 2 days ago
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Remote • Full-time • $64.00-$74.00/hr • Contract • Senior Level
Job Highlights
Using AI ⚡ to summarize the original job post
The Systems Engineer at Randstad US in Pittsburgh, Pennsylvania, will be responsible for the technical approach, system top level design, feasibility of potential technical solutions, and allocation of derived requirements onto affected subsystems. This role involves planning and executing system-level design reviews, owning system-level defect analysis and remediation during integration, verification, and validation phases, and supporting Product Risk Management, regulatory and standard fulfillment, and country approval. The position requires a minimum of 5 years of experience in developing complex medical devices, with a focus on systems engineering, and a strong understanding of system design processes.
Responsibilities
- Develop complex medical devices with a focus in systems engineering (hardware, software, consumables).
- Understand System Design process, including Model-Based (MBSE/V-Model) Design approach.
- Experience in test-Driven design methodologies.
- Utilize analytical and architectural thinking, system view, physical insight, flexibility, and a hands-on mentality.
- Effective communication, computer, documentation, presentation, and interpersonal skills.
- Ability to work independently, cross-functionally, and collaboratively.
- Strong knowledge of Medical Device/ FDA Quality System Regulations (ISO 13485/14971/10993/18562, 17510 2015, IEC 62366 etc.) and clearance processes.
Qualifications
Required
- Minimum of 5 years experience in developing complex medical devices.
- Focus in systems engineering (hardware, software, consumables).
- Experience in Sleep Therapy/Ventilation products and accessories highly desired.
- Strong understanding of System Design process.
- Experience in test-Driven design methodologies.
- Effective communication, computer, documentation, presentation, and interpersonal skills.
- Ability to work independently, cross-functionally, and collaboratively.
- Strong knowledge of Medical Device/ FDA Quality System Regulations and clearance processes.
About Randstad US
Randstad is a wholly-owned subsidiary of Randstad N.V., the world's largest HR services provider. Driven to become the world's most valued 'working life partner', supporting as many people as possible in realizing their true potential throughout their working life, we provide companies with the high quality, diverse, and agile workforces they need while helping people get rewarding jobs and stay relevant in the ever-changing world of work. Randstad offers outsourcing, consulting and workforce management solutions for generalist and specialist disciplines, including technology, engineering, accounting and finance, clinical and non-clinical healthcare, human resources, legal, life sciences, manufacturing and logistics, office and administration and sales and marketing.
Full Job Description
+ pittsburgh , pennsylvania (remote)
+ posted today
**job details**
summary
+ $64 - $74 per hour
+ contract
+ bachelor degree
+ category computer and mathematical occupations
+ reference1065895
job details
job summary:
+ technical approach, system top level design, feasibility of potential technical solutions, and allocation of derived requirements (including functionality, interface specifications and design budgets) onto affected subsystems.
+ Plans and executes system-level design reviews.
+ Owns system-level defect analysis and remediation during System Integration, Verification and Validation phases.
+ Support Product Risk Management, regulatory and standard fulfillment and country approval.
+ Manage technical risk by conducting thorough risk analyses, including Design Failure Mode and Effects Analysis (DFMEA), and developing risk control measures.
location: Pittsburgh, Pennsylvania
job type: Contract
salary: $64 - 74 per hour
work hours: 8am to 4pm
education: Bachelors
responsibilities:
+ You've acquired a minimum of 5 years experience successfully developing complex medical devices and a focus in systems engineering (hardware, software, consumables), with experience in Sleep Therapy/Ventilation products and accessories highly desired.
+ You have a strong understanding of System Design process, including Model-Based (MBSE/V-Model) Design approach-conceptualization, writing requirements, functional and technical design, check & optimize, verification, integration and finally validation.
+ You have experience in test-Driven design methodologies, analytical and architectural thinking, system view, physical insight, flexibility, and a hands-on mentality to deliver sustainable results and creative solutions.
+ You have effective communication, computer, documentation, presentation, and interpersonal skills, as well as the ability to work independently, cross-functionally, and collaboratively.
+ You have strong knowledge of Medical Device/ FDA Quality System Regulations (ISO 13485/14971/10993/18562 ,17510 2015, IEC 62366 etc.) and clearance processes.
qualifications:
+ Experience level: Experienced
+ Minimum 5 years of experience
+ Education: Bachelors (required)
skills:
+ Professional EngineerEqual Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.At Randstad Digital, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad Digital offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).This posting is open for thirty (30) days.
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