Senior Mechanical Engineer – Benchtop Blood Gas Platform jobs in United States
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Siemens Healthineers · 8 hours ago

Senior Mechanical Engineer – Benchtop Blood Gas Platform

Siemens Healthineers is a leader in medical technology, committed to pioneering breakthroughs in healthcare. The Senior Mechanical Engineer will be responsible for the design, development, testing, and documentation of mechanical subsystems for a next-generation diagnostic device intended for critical care environments, while also managing external design and manufacturing partners.

Health CareHealth DiagnosticsMedicalMedical Device
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H1B Sponsor Likelynote

Responsibilities

Design and develop robust, cost-effective mechanical systems including fluidic interfaces, enclosures, and electromechanical components
Create detailed CAD models, engineering drawings, BOMs, and material specifications to support manufacturability and performance
Design and build jigs, fixtures, and test apparatus for product assembly and verification, as required
Develop and execute mechanical test protocols; analyze results and use the data to drive design improvements
Conduct verification and validation testing and generate comprehensive test reports
Prepare and maintain mechanical design documentation in accordance with ISO 13485 and FDA Design Control requirements
Author production procedures and equipment operation documentation to support manufacturing readiness
Contribute to Interface Control Documents (ICDs) and Design History Files (DHFs)
Manage technical interactions with external design and manufacturing partners, ensuring alignment on specifications, timelines, and quality standards
Facilitate bidirectional knowledge transfer, including review of partner deliverables and creation of training materials
Contribute to the definition of mechanical requirements and ensure traceability through design outputs and verification testing
Collaborate with Electrical Engineering, Software, Assay, Quality, Regulatory, and Manufacturing teams to ensure mechanical designs meet system-level requirements and integration constraints
Participate in design reviews and contribute to risk assessments (e.g., FMEAs) for mechanical subsystems
Lead structured problem-solving efforts and root cause investigations for mechanical issues

Qualification

Mechanical DesignCAD SoftwareFDA Design ControlsISO 13485Mechanical TestingPrototypingProject ManagementAnalytical SkillsCommunication SkillsTeam Collaboration

Required

Bachelor's degree in Mechanical or Biomechanical Engineering or related discipline; Advanced degrees preferred
10+ years of experience in mechanical design and testing within the medical device or IVD industry
Proficiency in CAD software (preferably SolidWorks) and mechanical simulation/analysis
Experience designing small, close-tolerance parts and devices for regulated environments
Strong understanding of FDA Design Controls, ISO 13485, and ISO 14971
Skilled in hands-on prototyping, debugging, and troubleshooting
Experience writing design documentation and specifications that meet regulatory requirements
Demonstrated ability to manage external vendors and facilitate technical knowledge transfer
Strong analytical, communication, and project management skills
Ability to work effectively in a dynamic, cross-disciplinary team environment

Benefits

Medical insurance
Dental insurance
Vision insurance
401(k) retirement plan
Life insurance
Long-term and short-term disability insurance
Paid parking/public transportation
Paid time off
Paid sick and safe time

Company

Siemens Healthineers

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Siemens Healthineers is a healthcare technology company that provides diagnostic and therapeutic products and services. It is a sub-organization of Siemens.

H1B Sponsorship

Siemens Healthineers 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
Represents job field similar to this job
Trends of Total Sponsorships
2025 (104)
2024 (70)
2023 (64)
2022 (89)
2021 (50)
2020 (86)

Funding

Current Stage
Public Company
Total Funding
$2.76B
Key Investors
Ontario Together Fund
2021-05-25Grant· $2.5M
2021-03-25Post Ipo Equity· $2.76B
2018-03-16IPO

Leadership Team

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Enno Nehrbass
SVP / Head of Strategy & Collaboration Mgmt Diagnostic Imaging
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Sebastian Kronmueller
Vice President, Head of Strategy & Business Development - Laboratory Diagnostics
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Company data provided by crunchbase