Accountabilities:

• Serve as the technical lead for cross-functional teams responsible for the design, development, and commercialization of biologic/device combination products.
• Provide subject matter expertise for patient-centric delivery systems including prefilled syringes, autoinjectors, needle safety devices, and related technologies.
• Develop and maintain product realization documentation such as user requirements specifications, design inputs, verification plans, validation protocols, and technical reports.
• Oversee test method development, validation activities, design verification testing, and statistical analysis performed by external laboratories and manufacturing partners.
• Lead human factors engineering strategies and coordinate formative and summative studies with specialized service providers to support design validation activities.
• Collaborate with Quality teams to strengthen combination product quality systems and ensure compliance with applicable cGMP regulations and industry standards.
• Support technology transfer, process validation, manufacturing oversight, and commercial readiness activities across external manufacturing sites and supply chain partners.
• Review and approve manufacturing documentation, validation reports, batch records, investigations, and technical studies to ensure product quality and regulatory compliance.
• Act as a technical SME during root cause investigations, deviation management, and risk assessments in accordance with ISO 14971 and related standards.
• Contribute to regulatory submissions including INDs, IMPDs, BLAs, amendments, and other global filings while presenting technical findings to internal and external stakeholders.

Requirements:

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering, or a related technical discipline; advanced degree preferred.
• Minimum of 10 years of relevant experience within biotechnology, pharmaceutical, medical device, or combination product development environments.
• Hands-on experience developing biologic/device combination products, including prefilled syringes, autoinjectors, needle safety devices, or on-body injectors.
• Strong expertise in design controls, user requirements, design verification and validation, process validation, and product transfer activities.
• Solid understanding of regulatory requirements and industry standards related to combination products, including 21 CFR Part 4, 21 CFR 820, ISO 13485, and ISO 14971.
• Experience working with CMOs, CROs, external device suppliers, and outsourced manufacturing operations.
• Proven ability to execute root cause investigations, risk management activities, and data-driven technical analyses.
• Excellent written and verbal communication skills with the ability to present technical concepts clearly across cross-functional teams and external partners.
• Strong organizational, multitasking, and project leadership abilities in fast-paced and evolving environments.
• Ability to travel up to 25%, including domestic and international travel to vendor and manufacturing sites.
• Ability to work across multiple time zones and collaborate effectively within global teams.

Benefits:

• Competitive salary range between $180,000 and $200,000 USD.
• Performance bonus opportunities and equity grant participation.
• Comprehensive medical, health, welfare, and retirement benefits package.
• Generous paid time off including three weeks of PTO, paid sick leave, and two company-wide shutdown weeks annually.
• Fully remote work flexibility within the United States.
• Opportunity to contribute to a fast-paced and highly innovative biotechnology organization.
• Strong culture focused on collaboration, professional growth, and continuous learning.
• Access to development resources and opportunities for career advancement.
• Regular in-person team meetings and collaborative events to strengthen relationships and drive innovation.