Device Development & Manufacturing Lead (Hybrid/Remote)

Viridian Therapeutics, Inc.; Waltham (MA); Hybrid; USD 120,000 - 180,000; Full time

Benefits offered by this job

Stock options

Medical insurance

Dental insurance

Vision insurance

Disability coverage

Life insurance

401(k) match

Employee stock purchase

Paid vacation

Company holidays

Wellness programs

Job summary

Viridian Therapeutics, Inc. seeks a Manager, Device Development & Manufacturing to oversee the development and manufacturing of injectable drug delivery devices.

The role supports technology selection, development through to commercialization, and compliance with design control and regulatory standards. The ideal candidate brings 6+ years in medical device engineering, with experience in combination products and external collaboration with CMOs.

Qualifications

• Requires 6+ years in process or product engineering in medical devices or pharma.
• Experience with device development and combination products preferred.
• Familiar with design control, regulatory standards, and ISO/IEC guidelines.

Responsibilities

• Participate in vendor selection for device components and labs.
• Coordinate early human factors assessments with external vendors.
• Develop device sections of combination products from concept to launch.
• Prepare regulatory submissions with the CMC team and serve as device SME.
• Create design verification/validation plans and design transfer docs.
• Establish device outputs like drawings and specs.
• Lead design verification testing with external partners.
• Lead risk assessments for design, use, and process.
• Translate design into CMOs production specs.
• Support manufacturing process development and validation at CMOs.
• Oversee design validation, labeling, and packaging development.
• Organize design reviews to ensure compliant closure of design controls.
• Develop analytical methods for device attributes.
• Coordinate feasibility studies for new tech (e.g., auto-injectors).
• Monitor competitive landscape in device tech and regulation.

Skills

Process engineering

Device development

Regulatory knowledge

Quality systems

Cross-functional collaboration

Analytical skills

Vendor management

MS Office

Education

Mechanical Eng degree

Advanced degree

Tools

MS Office

Job description

Viridian Therapeutics, Inc. seeks a Manager, Device Development & Manufacturing to oversee the development and manufacturing of injectable drug delivery devices.

The role supports technology selection, development through to commercialization, and compliance with design control and regulatory standards. The ideal candidate brings 6+ years in medical device engineering, with experience in combination products and external collaboration with CMOs.