Remote Device Development & Manufacturing Manager

Kids for the Future; Waltham (MA); Hybrid; USD 118,000 - 145,000; Full time

Benefits offered by this job

Competitive pay and stock options

Medical, dental, and vision insurance

401(k) Company Match

Job summary

Viridian Therapeutics, Inc. in Waltham, MA is seeking a Manager, Device Development & Manufacturing to lead the development and manufacturing of injectable drug delivery devices, from technology selection through to commercialization.

The role requires expertise in design controls and regulatory standards for combination products, with prior work on prefilled syringes, autoinjectors, or wearable injectors preferred. Hybrid or remote options available with travel up to 15%.

Qualifications

• Requires 6+ years’ experience in process or product engineering within the medical device, packaging, or pharmaceutical manufacturing fields.
• BS /BA in Mechanical Engineering, product design, life sciences, or related technical field; advanced degrees a plus.
• Proven record of successful development of medical devices and/or combination products.
• Expert knowledge of regulatory and compliance requirements for device design and development and combination products (21 CFR 820, Part 4) and ISO standards.

Responsibilities

• Participate in vendor selection for drug delivery devices and CMOs.
• Plan and coordinate formative human factors assessments with external vendors.
• Develop device components of combination products from initiation to launch, ensuring regulatory compliance.
• Generate source documentation with CMC team and act as SME for device/combination products.
• Follow design control processes to develop specs, verification/validation plans, transfer plans, and completion reports.
• Establish device outputs like drawings, schematics, and product specs.
• Lead design verification testing with external vendors.
• Lead risk assessments for design, use, and process.
• Translate product design into production specs at CMOs (design transfer).
• Support manufacturing process development and process validation at CMOs.
• Support design validation, human factors engineering assessments, packaging and labeling development.
• Organize design reviews to ensure controlled completion of design control requirements.
• Validate analytical methods related to device attributes.
• Coordinate feasibility studies for emerging technologies.
• Collaborate to monitor competitive landscape and regulatory trends in drug delivery devices.

Skills

Design control knowledge

Regulatory compliance

Project leadership

Vendor management

Education

BS /BA in Mechanical Engineering or related field

Tools

Microsoft Office

Job description

Viridian Therapeutics, Inc. in Waltham, MA is seeking a Manager, Device Development & Manufacturing to lead the development and manufacturing of injectable drug delivery devices, from technology selection through to commercialization.

The role requires expertise in design controls and regulatory standards for combination products, with prior work on prefilled syringes, autoinjectors, or wearable injectors preferred. Hybrid or remote options available with travel up to 15%.