Mechanical Engineer II - Sustaining (Medical Devices)

Location: On-site in Chelmsford, Massachusetts; applicants must live within a reasonable commuting distance. Relocation is not offered.

Salary: $82,400–$91,000 annually, plus eligibility for an annual bonus.

Company

Medical technology company developing devices, software, and services for diagnosing and treating serious cardiopulmonary and respiratory conditions, including defibrillator and ventilator products.

What you will do

• Design and develop parts, assemblies, enclosures, and subsystems for new and existing defibrillator and ventilator products.
• Perform engineering mechanics, thermal, flow, and tolerance analyses addressing ingress protection, pneumatics, shock and vibration, EMI isolation, and thermal management.
• Create drawings, assembly documents, bills of materials, purchasing specifications, and engineering change orders for production release.
• Prepare and support risk assessments, design and process FMEAs, regulatory submissions, and design history file documentation.
• Lead or participate in design reviews, supplier presentations, prototype evaluations, troubleshooting, root-cause investigations, product complaints, and CAPAs.
• Develop test plans, design of experiments, validation protocols, and verification and validation testing with technical reports and data analysis.

Requirements

• Bachelor of Science in Mechanical Engineering.
• 3–5 years of mechanical engineering and product design experience.
• Experience designing and documenting molded plastic housings, sheet metal, gaskets, PCBs, LCDs, cables, and labels for embedded systems.
• Proficiency with SolidWorks Part Design and Detailed Drawings; PDM and Simulation knowledge is a plus.
• Working knowledge of ASME Y14.5 2009 drawing creation, with strong written and verbal communication skills.
• Must be able to work on-site in Chelmsford, Massachusetts, without relocation or immigration sponsorship. Applicants requiring H1B, TN, STEM, OPT, or other hirify.global immigration sponsorship are not eligible.

Nice to have

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

Culture & Benefits

• Work within a cross-functional R&D organization focused on improving patient outcomes.
• Culture emphasizing innovation, self-motivation, continuous improvement, and an entrepreneurial spirit.
• Comprehensive employee benefits.
• Annual bonus eligibility.

Hiring process

• Applications are accepted on an ongoing basis until the position is filled.