6+ years of experience in process or product engineering (medical device, packaging, or pharmaceutical)
BS/BA in Mechanical Engineering, product design, life sciences, or related technical field; advanced degrees are a plus
Proven success in developing medical devices and combination products
Expert knowledge of regulatory requirements for device design and development
Familiarity with ISO standards related to medical devices
Experience leading projects with external design and manufacturing partners
Strong communication skills at all levels, with a commitment to ethical standards
Responsibilities
Participate in the selection of vendors for drug delivery devices and related services
Plan early human factors assessments with external vendors
Support the full lifecycle development of combination products and ensure regulatory compliance
Generate documentation and assist in regulatory submissions, serving as a subject matter expert
Follow design processes to create specifications, verification/validation plans, and design transfer plans
Establish technical outputs, including designs and specifications for the device constituent
Lead design verification testing with external vendors
Ensure successful design transfer to CMOs and support manufacturing process validation
Benefits
Competitive pay and stock options for all employees
Comprehensive medical, dental, and vision insurance
Paid parental leave
Short- and long-term disability coverage
Life, travel, and AD&D insurance
401(k) company match with immediate vesting
Employee stock purchase plan
Generous vacation plan and company holiday shutdowns
Access to various health programs including mental and financial health services
Full Job Description
Description
Reporting to the Director, Device Development & Manufacturing, the Manager, Device Development & Manufacturing will support the technical development and manufacturing of injectable drug delivery devices, from technology selection through development up to commercialization. The ideal candidate will have knowledge in leading design control activities and the corresponding documentation in compliance with current combination product quality and regulatory standards. Prior experience developing prefilled syringes, autoinjector and/or wearable injectors is highly preferred.
This role may be based in our Waltham, MA headquarters, which would be a hybrid role, or it can also be fully remote. Our office-based employees are required to work in the office three (3) days a week. If remote, travel to headquarters for meetings would be required at the discretion of management.
Responsibilities (including, but not limited to):
Participate in vendor selection process for drug delivery devices, device assembly CMOs, and analytical test labs
Plan and coordinate early formative human factors assessments with external vendor(s)
Support development of the device constituent component of combination products, from initiation through technology selection, development, clinical trials, and commercial launch, ensuring compliance with all regulatory requirements
Work with CMC team to generate source documentation and contribute to preparation of regulatory submissions, acting as subject mater expert for device and combination products
Follow design and development processes to develop specifications, design verification and validation plans and protocols, design transfer plans, and associated completion reports
Establish design outputs for the device constituent such as technical drawings, schematics, and product specifications
Lead design verification testing activities with external vendors
Lead cross-functional team in conducting and maintaining design, use, and process risk assessments
Ensure product design is adequately translated into production specifications at CMOs (design transfer)
Support manufacturing process development and process validation activities at CMOs
Support design validation activities, including but not limited to human factors engineering assessments
Support design and development of product packaging and labeling (e.g., Instructions for Use)
Organize and host design review meetings to ensure controlled and documented completion of design control requirements in alignment with quality systems
Support development and validation of analytical methods related to device functional attributes
Plan and coordinate feasibility assessments for emerging technologies (e.g., large volume autoinjector, high viscosity formulations) to inform product pipeline
Collaborate with competitive intelligence to maintain a high state of awareness of the competitive landscape and state-of-the-art in drug delivery device technology, including trends in clinical practice and regulatory landscape
Qualifications:
Requires 6+ years' experience in process or product engineering within the medical device, packaging, or pharmaceutical manufacturing fields. Direct experience with drug delivery devices is highly desirable
BS /BA in Mechanical Engineering, product design, life sciences, or other related technical field. Advanced degrees a plus
Proven record of successful development of medical devices and/or combination products
Expert knowledge of the regulatory and compliance requirements for device design and development and combination products (21 CFR 820, 21 CFR Part 4)
Knowledge in the application of ISO 13485, ISO 14971, ISO 10993, ISO 11608, ISO 23908 and other appropriate standards
Experience leading projects with external design, development and manufacturing partners
Constructive partnership and communication skills, both verbally and written, at all levels internally and externally
Understanding of statistical sampling and statistical analysis of test results
Strong commitment to ethical standards
Proficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.)
Ability to travel up to 15%
The salary range for this position is commensurate with experience
Viridian offers a comprehensive benefits package including:
Competitive pay and stock options for all employees
Medical, dental, and vision insurance
100% Paid Parental Leave
Short- and long-term disability coverage
Life, Travel and AD&D
401(k) Company Match with immediate company vest
Employee Stock Purchase plan
Generous vacation plan and paid company holiday shutdowns
Various fertility, mental, financial, and proactive physical health programs
About Viridian Therapeutics
Viridian Therapeutics is a biotechnology company that develops gene therapies for inherited diseases. The company's lead product candidate, VRDN-001, is a gene therapy for Friedreich's ataxia, a rare genetic disease that causes progressive damage to the nervous system. Viridian Therapeutics was founded in 2018 and is headquartered in Cambridge, Massachusetts.
