DescriptionReporting 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
