Mechanical Engineer II - Sustaining (Medical Devices)

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

Annual salary: $82,400–$91,000, plus eligibility for an annual bonus.

Company

hirify.global develops medical devices, software, and related services for diagnosing and treating serious cardiopulmonary and respiratory conditions.

What you will do

• Design and develop parts, assemblies, enclosures, and subsystems for defibrillator and ventilator products.
• Perform mechanical, thermal, flow, and tolerance analyses, including work related to 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.
• Lead or participate in design reviews, troubleshooting, root-cause investigations, product complaint resolution, and CAPA activities.
• Develop test plans, design-of-experiments, validation protocols, and verification and validation documentation.
• Support risk assessments, design and process FMEA, technical reporting, statistical analysis, project schedules, budgets, and regulatory submissions.

Requirements

• Bachelor of Science in Mechanical Engineering.
• 3–5 years of mechanical engineering and product design experience.
• Proficiency with SolidWorks Part Design and Detailed Drawings; PDM and Simulation experience is a plus.
• Working knowledge of drawing creation according to ASME Y14.5-2009.
• Experience designing and analyzing molded plastic housings, sheet metal, gaskets, PCBs, LCDs, cables, and labels for embedded systems packaging.
• Must work on-site in Chelmsford, Massachusetts, and must not require ZOLL immigration sponsorship now or in the future.

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 team of engineers and scientists.
• Culture emphasizing innovation, self-motivation, continuous improvement, and an entrepreneurial spirit.
• Opportunity to contribute to products intended to improve outcomes for patients with critical cardiopulmonary conditions.
• Comprehensive benefits and eligibility for an annual bonus plan.