Design Transfer, Tech Transfer Strategy

Role Overview

• Serve as the primary Quality partner to the Technology Transfer team, providing strategic guidance and oversight throughout assay design transfer and tech transfer activities.
• Lead development and execution of comprehensive design transfer and technology transfer quality strategies that ensure compliant, sustainable product realization.
• Collaborate with Design Quality, Quality Operations, R&D, and Manufacturing teams to ensure alignment on design transfer deliverables, risk management, and process capability expectations.
• Provide expert interpretation of applicable global regulatory and quality system requirements (e.g., ISO 13485, IVDR, FDA QSR) as they relate to design transfer, process transfer, verification/validation, and manufacturing readiness.
• Apply deep product and process knowledge to assess transfer risks, guide process understanding, and ensure adequate controls are defined and implemented during scale-up.
• Support global audit and inspection activities as a subject matter expert and auditee for design transfer, tech transfer, and related quality system elements.
• Proactively identify quality gaps, systemic risks, and continuous improvement opportunities within design transfer frameworks and lead cross-functional teams to implement solutions.
• Mentor engineers and contribute to development of organizational capability in design transfer strategy and regulatory compliance.
• Perform other work-related duties as assigned.

Requirements

• Bachelor’s degree in Life Sciences, Engineering, or a related technical discipline required.
• 10+ years of progressive experience in Quality, Compliance, or related fields within the Medical Device, IVD, or Biopharmaceutical industries
• Strong understanding of Quality System regulations and standards, including ISO 13485, FDA 21 CFR 820, and IVDR.
• Strong product and process knowledge relevant to assay development, verification/validation, and manufacturing workflows.
• Demonstrated success driving Quality and Compliance initiatives that align with business strategy and regulatory expectations.
• Excellent collaboration, influence, and communication skills across functional and organizational boundaries.
• Strong analytical and problem-solving skills, with experience using data to drive decision-making and improvement.
• Commitment to scientific integrity, compliance excellence, and continuous improvement.
• Expert-level knowledge of Design Transfer and Technology Transfer for IVD assays, including process readiness, scale-up, and transfer of product requirements into manufacturing.
• Deep understanding of IVD regulatory and quality system requirements, such as ISO 13485, IVDR, FDA QSR, risk management (ISO 14971), and design control principles.
• Strong product and process knowledge relevant to assay development, verification/validation, and manufacturing workflows.
• Ability to interpret complex regulatory requirements and translate them into actionable design transfer and quality strategies.
• Demonstrated experience evaluating process capability, process controls, and design outputs to ensure manufacturability and compliance.

Benefits

• medical
• dental
• vision
• life insurance
• disability insurance
• 401(k) plan
• employee assistance program
• Employee Stock Purchase Plan
• paid time off (including sick time)
• paid Holidays