Device Engineering Sr. Engineer (Medical Devices)

Location: US - Massachusetts - Cambridge; based at the hirify.global Massachusetts site

Salary: $115,494.60–$156,257.40 annual base salary

Company

hirify.global is a biotechnology company developing, manufacturing, and delivering medicines for serious illnesses across oncology, inflammation, general medicine, and rare disease.

What you will do

• Execute Design for Robustness activities across kinematic, tolerance, structural strength, material, DFA, and DFM disciplines.
• Provide technical recommendations to improve device performance, reduce sensitivity to variation, and strengthen system robustness.
• Collaborate with discipline subject-matter experts and cross-functional teams to identify risks, mitigations, and design trade-offs.
• Lead structured problem-solving and root-cause analysis for design, test, and field performance issues.
• Work with manufacturing, quality, and suppliers to reduce variation-driven failures and improve product robustness.
• Support continuous improvement of robustness methods, tools, and governance frameworks.

Requirements

• Doctorate degree; or a master's degree and 2 years of engineering experience; or a bachelor's degree and 4 years of engineering experience; equivalent combinations with an associate degree or high school diploma are also accepted.
• 5+ years of progressive mechanical engineering experience and 3+ years developing medical devices, ideally Class II or Class III devices.
• Hands-on experience with at least one Design for Robustness discipline, such as kinematic, tolerance, structural strength, material, DFA, or DFM design.
• Experience with drug/device combination products, injection molding, assembly processes, drawings, design documentation, and GMP deliverables.
• Knowledge of quality systems and applicable standards, including 21 CFR 820, ISO 13485, ISO 11608, and ISO 14971.
• Fluent English and the ability to work at the Massachusetts site are required.

Culture & Benefits

• Collaborative, innovative, and science-based working environment.
• Comprehensive health, dental, vision, life, disability, and flexible spending benefits.
• Retirement and savings plan with company contributions.
• Discretionary annual bonus and stock-based long-term incentives.
• Award-winning time-off plans and career development opportunities.
• Flexible work models may be available where business needs allow.

Hiring process

• Applications are accepted until a sufficient number of candidates are received or a candidate is selected.
• Sponsorship for this role is not guaranteed.