Senior Engineer, Device Technical Operations (Hybrid)

About the role

The Senior Engineer - Device Technical Operations is a key engineering role in the Device Development and Technology organization, responsible for building engineering capabilities for medical devices and combination products. The engineer manages internal and external manufacturing across development, scale-up, commercialization and design transfer, with a focus on complex drug-delivery systems such as autoinjectors, ophthalmic products and inhalation products. The role is hybrid and based in West Point, Pennsylvania.

Key responsibilities

• Use experience in design controls, design transfer, control strategies, device risk management and design verification testing to build value-added solutions for medical devices and combination products.
• Support internal and external component and combination product manufacturing globally.
• Identify issues early, solve problems and determine root causes.
• Build a design engineering mindset for medical devices and combination products in development and lifecycle management, in line with regulatory standards.
• Use engineering best practices and tools to optimize design and manufacturing decisions.
• Support responses to regulatory agency questions and pre-approval inspections, and support regulatory inspections.
• Develop and execute technology transfer plans, lead teams in late-stage development and work with internal and external partners.
• Foster inclusion and build strategic partnerships with manufacturing sites and partner groups.
• Ensure safety, quality and regulatory compliance, aligned with divisional and local site procedures, and maintain proficiency in ISO 13485, ISO 14971-2019 and other quality management systems.

Required profile

• Bachelor's degree in mechanical engineering, biomedical engineering or a related technical field (Chemical or Materials Engineering); advanced degree preferred.
• At least 5 years of experience in pharmaceutical, biologic, medical device or combination product engineering, with at least 2 years supporting commercial manufacturing.
• Demonstrated experience in injection molding, automation, complex assembly and packaging for medical device components; direct experience with autoinjectors, ophthalmic or inhalation products highly preferred.

Required skills

• Design controls, risk analysis, control strategies, design verification testing and process validation.
• Quality management systems and regulatory compliance.
• Preferred: construction processes, deviation management, continuous improvement, GMP documentation, materials science, process development engineering and product engineering.

What we offer

• Salary range of $117,000 to $184,200 for the primary location, with eligibility for annual bonus and long-term incentives.
• Medical, dental, vision and other insurance, retirement benefits including 401(k).
• Paid holidays, vacation and compassionate and sick days.