Sr Manager, Device Development and Manufacturing

Sr Manager, Device Development and Manufacturing

Work Location: Middlesex County, Massachusetts

Summary:

Seeking an experienced professional to lead device development and manufacturing activities for drug-device combination products. This role involves managing design history files, collaborating with external partners, and supporting regulatory submissions, with a focus on compliance and risk management.

Responsibilities:

• Oversee and maintain design history files, serving as the subject matter expert on design control and risk management for combination products.
• Coordinate with external vendors and partners to ensure timely advancement of project milestones and deliverables.
• Plan, execute, and support human factors studies, including conducting use-related risk assessments for device products.
• Lead design verification and validation activities to ensure product quality and regulatory compliance.
• Perform impact assessments for change control processes, including evaluations of design and risk management files.
• Prepare, review, and contribute to regulatory submissions and responses as required for device development projects.
• Support device selection and packaging design for new programs by conducting feasibility testing and analysis.
• Communicate project updates and key findings to stakeholders, ensuring alignment and transparency throughout development.

Qualifications:

• Bachelor's degree in mechanical or biomedical engineering or related field with 8+ years of relevant industry experience, or Master’s degree with 6+ years of relevant industry experience (preferred).
• Familiarity with regulations and standards such as 21 CFR Part 820/QMSR, ISO 13485, ISO 14971, IEC 62366, and related guidelines, with emphasis on design controls and risk management.
• Demonstrated experience working with combination products, including autoinjectors, co-packed kits, pre-filled syringes, or inhalers.
• Proven ability to manage multiple priorities and operate effectively in ambiguous situations.
• Strong commitment to compliance, quality, and ethical standards in all aspects of work.
• Willingness and ability to travel up to 5% as needed.
• Compensation is competitive and commensurate with experience.

Published Category: Manufacturing & Technical Operations