Senior Manager, Device Development

Apellis Pharmaceuticals • Waltham, MA

168d

About The Position

The Senior Manager, Device Development will be a key contributor within our device development team and will support the development of drug delivery devices for our innovative therapies. The successful candidate will be expected to work independently and as an effective, engaged team member in a fast-paced environment while collaborating with peers in a matrixed organization. Through the responsibility for the development of successful development activities, this position will embody the Apellis values and be part of the team accountable for delivering impactful new ways for our complement-based therapies to improve the lives of our patients.

Requirements

• Bachelor's Degree in Mechanical Engineering, Biomedical Engineering, Electrical Engineering, or similar.
• 7+ years of progressive experience as an engineer developing medical device or, preferably, combination products.
• Experience with combination product development is highly desirable.
• Experience with sterilization, especially low temperature modalities, is highly desirable.
• Deep knowledge of product development processes, including design controls and risk management.
• Strong leadership, communication, and organizational skills.
• Ability to work cross-functionally and influence without direct authority.
• Familiarity with relevant standards and guidance documents (e.g., ISO 11608, FDA Guidance for Combination Products).
• Execution of device design verification and validation, authoring documentation associated with Design Controls.
• Ability to start up and lead cross functional teams in the resolution of short-term issues or sustained performance for long-term goals.
• Demonstrated ability to project manage technology transfer and/or new product launches.
• Excellent organizational, written and verbal communication & negotiation skills.
• Experience with CAPA, FMEA, and RCA tools in a highly regulated manufacturing environment.
• Experience in managing external vendors and global teams.

Responsibilities

• Lead end-to-end development of devices and combination products (e.g., pre-filled syringes, autoinjectors, wearable injectors) from need through commercialization.
• Collaborate with cross-functional teams (Technical Operations, Quality, Regulatory, Manufacturing, Human Factors, Clinical) to align technical and strategic goals.
• Develop and maintain project timelines, budgets, and risk management plans.
• Manage external development partners, contract manufacturers, and other external resources.
• Ensure compliance with applicable regulatory requirements (e.g., FDA 21 CFR Part 820, ISO 13485, EU MDR).
• Oversee design control activities including design verification and validation, risk management (ISO 14971), and human factors engineering (IEC 62366).
• Author and review technical documentation including design history files, regulatory submissions, and technical reports.
• Provide technical presentations at functional and multi-functional settings.
• Anticipate challenges and develop mitigation strategies to keep deliverables on pace.
• Participate in and support regulatory submissions (IND, NDA, BLA, 510(k), PMA, CE marking).
• Stay informed of industry trends, technological advancements, and changes in regulatory landscapes.
• Other duties as assigned.

Benefits

• 401(k) plan with company match
• Inclusive family building benefits
• Flexible time off
• Summer and winter shutdowns
• Paid family leave
• Disability and life insurance

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Professional, Scientific, and Technical Services
• Education Level: Bachelor's degree