Senior Manager, Device Development

@ Apellis

Position Summary

The Senior Manager, Device Development will be a key contributor within our device development team at Apellis. In this role, you will support the development of drug delivery devices for innovative therapies, working independently and collaboratively in a fast-paced, matrixed organization.

Key Responsibilities

• Lead end-to-end development of devices and combination products from concept to commercialization.
• Collaborate with cross-functional teams including Technical Operations, Quality, Regulatory, Manufacturing, Human Factors, and Clinical.
• Develop project timelines, budgets, and risk management plans.
• Manage external development partners and contract manufacturers.
• Ensure compliance with regulatory requirements (FDA 21 CFR Part 820, ISO 13485, EU MDR).
• Oversee design control activities such as design verification/validation and risk management (ISO 14971, IEC 62366).
• Author and review technical documentation including design history files and regulatory submissions.
• Provide technical presentations in various settings.
• Anticipate challenges and develop mitigation strategies.
• Participate in regulatory submissions (IND, NDA, BLA, 510(k), PMA, CE marking).

Education, Experience & Skills

Required qualifications include a Bachelor's Degree in Mechanical, Biomedical, Electrical Engineering or a related field and 7+ years of progressive experience in medical device or combination product development. Candidates should have deep knowledge of product development processes, design controls, risk management, and experience managing external vendors and global teams.

Work Environment & Travel

This role is primarily office-based in a professional environment with occasional physical tasks and up to 20% travel, both domestic and international.

Benefits & Company Background

Apellis offers comprehensive benefits including a 401(k) plan, inclusive family benefits and flexible time off. Apellis Pharmaceuticals is a global biopharmaceutical company dedicated to advancing complement-based therapies.

Key Skills/Competency

Senior Manager, Device Development: device development, combination products, design controls, risk management, regulatory compliance, project management, cross-functional collaboration, technical documentation, vendor management, FDA/ISO standards.