Siemens Healthineers
Senior Mechanical Engineer – Benchtop Blood Gas Platform
Siemens Healthineers, Walpole, Massachusetts, us, 02081
Senior Mechanical Engineer – Benchtop Blood Gas Platform
1 day ago Be among the first 25 applicants
Join us in pioneering breakthroughs in healthcare. We foster an inclusive, flexible environment that encourages growth and embraces diversity. You will be part of a global community that works toward sustainable, impactful solutions for patients worldwide.
Key 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.
Required Qualifications
Bachelor’s degree in Mechanical, Biomechanical, or related engineering 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.
Base Pay Range : Min $143,900 - Max $215,860
Benefits : Medical, dental, vision insurance; 401(k) retirement plan; life, short‑term and long‑term disability insurance; paid parking/public transportation; paid time off; paid sick and safe time.
Equal Employment Opportunity Statement : Siemens Healthineers is an Equal Opportunity and affirmative action employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, national origin, citizenship, ancestry, sex, age, physical or mental disability unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender status, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state or local law. Reasonable accommodations are made for applicants and employees as required by federal law.
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Join us in pioneering breakthroughs in healthcare. We foster an inclusive, flexible environment that encourages growth and embraces diversity. You will be part of a global community that works toward sustainable, impactful solutions for patients worldwide.
Key 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.
Required Qualifications
Bachelor’s degree in Mechanical, Biomechanical, or related engineering 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.
Base Pay Range : Min $143,900 - Max $215,860
Benefits : Medical, dental, vision insurance; 401(k) retirement plan; life, short‑term and long‑term disability insurance; paid parking/public transportation; paid time off; paid sick and safe time.
Equal Employment Opportunity Statement : Siemens Healthineers is an Equal Opportunity and affirmative action employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, national origin, citizenship, ancestry, sex, age, physical or mental disability unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender status, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state or local law. Reasonable accommodations are made for applicants and employees as required by federal law.
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