Senior Engineer, Device Technical Operations (Medical Devices)

Location: Hybrid; primary location is West Point, Pennsylvania, USA. US and Puerto Rico residents only. Travel requirements: 10%.

Salary: $117,000–$184,200 annual base salary, plus eligibility for annual bonus and long-term incentive where applicable.

Company

hirify.global is a pharmaceutical and healthcare company developing and commercializing medicines, medical devices, and combination products.

What you will do

• Build engineering capabilities for medical devices and combination products, including autoinjectors, ophthalmic products, and inhalation products.
• Manage internal and external component and combination-product manufacturing across development, scale-up, commercialization, and design transfer.
• Apply design controls, device risk management, control strategies, design verification testing, and engineering best practices.
• Identify issues from minimal signals, determine root causes, and develop solutions that improve product and process robustness.
• Develop and execute technology-transfer and late-stage development plans while partnering with manufacturing sites, external partners, and internal teams.
• Support regulatory agency responses, pre-approval inspections, and ongoing compliance with quality and regulatory requirements.

Requirements

• Bachelor’s degree in mechanical engineering, biomedical engineering, or a related technical field is required; related fields include chemical engineering and materials engineering.
• At least 5 years of experience in pharmaceutical, biologic, medical device, or combination-product engineering, including at least 2 years supporting commercial manufacturing.
• Expertise in design controls, risk analysis, control strategies, design verification testing, process validation, quality management systems, and regulatory compliance.
• Technical experience with injection molding, automation, complex assembly, and packaging operations for medical-device or combination-product component manufacturing.
• Experience with construction processes, deviation management, continuous improvement, engineering leadership and support, GMP documentation, materials science, performance monitoring, process development engineering, product engineering, root-cause identification, and technology development.
• Ability to maintain proficiency in ISO 13485, ISO 14971:2019, and other relevant quality management systems.
• Ability to work in accordance with safety, quality, regulatory, divisional, and local site procedures.

Nice to have

• Master’s degree or PhD.
• Direct experience with autoinjectors, ophthalmic products, or inhalation products.

Culture & Benefits

• Hybrid work arrangement with first-shift, daytime hours.
• Medical, dental, vision, and other insurance benefits for employees and families.
• Retirement benefits including a 401(k).
• Paid holidays, vacation, compassionate leave, and sick days.
• Inclusive environment emphasizing diverse perspectives, respectful challenge, and collaborative problem-solving.
• Visa sponsorship is not available; no relocation is offered.