Mechanical Engineer II (Medical Devices)

TL;DR

Mechanical Engineer II (Medical Devices): Supporting sustaining engineering efforts for defibrillator and ventilator product lines with an accent on part design, assembly optimization, and regulatory compliance. Focus on conducting mechanics and thermal analysis, troubleshooting root causes for product complaints, and developing validation protocols.

Location: Must be based within a reasonable commuting distance of Chelmsford, MA. This role does not offer relocation.

Salary: $82,400 – $91,000 per year

Company

hirify.global develops and delivers innovative lifesaving medical devices and software solutions for EMS, hospital, public safety, and military customers globally.

What you will do

• Design and develop new assemblies and parts for defibrillator and ventilator products.
• Perform engineering mechanics, thermal/flow, and tolerance analyses.
• Create detailed design documentation, including part drawings, Bills of Materials, and purchasing specifications.
• Manage Engineering Change Orders (ECOs) to control and release designs under the Quality System.
• Lead troubleshooting activities and root cause investigations to resolve product complaints and CAPAs.
• Develop and execute test plans, DOEs, and validation IQ/OQ/PQ protocols.

Requirements

• Bachelor of Science in Mechanical Engineering.
• 3 to 5 years of experience in mechanical engineering and product design.
• Must reside within commuting distance of Chelmsford, MA.
• No immigration sponsorship provided (H1B, TN, STEM, OPT, etc.).
• Proficiency with SolidWorks, including Part Design and Detailed Drawings.
• Working knowledge of drawing creation per ASME Y 14.5 2009.

Nice to have

• Experience in medical or other highly regulated industries.
• Working knowledge of IEC 60601, FDA, GMP, or ISO 13485:2003.
• SolidWorks CSWP certification.

Culture & Benefits

• Commitment to improving patient outcomes and saving lives.
• Culture that values innovation, self-motivation, and an entrepreneurial spirit.
• Comprehensive corporate benefits plans.
• Eligibility for an annual bonus in accordance with the company's bonus plan.