Job Description

Location: Woburn, MA

Vaxess is an NIH and venture-funded company developing a pipeline of next-generation therapeutics on the Microneedle Array Patch (MAP) platform. With only five minutes of wear-time on the skin, the self-applied MAP enables sustained delivery in the skin. The platform combines high temperature stability with simplified application to dramatically alter the way that drugs are delivered. Vaxess is committed to enabling products that are not only more effective, but also more accessible to patients around the world.

Device development at Vaxess is cross-disciplinary, integrating mechanical engineering, biomedical engineering, chemical engineering, biomaterials, chemistry, biology, and human factors to address important unmet medical needs. We are seeking a talented, collaborative, and highly motivated engineer with a proven track record in medical device development to support the design of our novel delivery system. 

Responsibilities

• Work under the VP of Device Development to design the re-usable MAP delivery device.  Focus for this role will be on product design, development, and design for high volume manufacturability.
• Support product development in support of pre-clinical and clinical studies.
• Work closely with the multidisciplinary Vaxess team and external consultants with specialties spanning Human Factors, Industrial Design, Packaging, Manufacturing, Engineering, Biocompatibility, Quality, and Regulatory. 
• Lead the selection and management of outside vendors.
• Generate all required documents to support device related components of design control requirements (21 CFR 820, ISO 13485 ISO 14971) and regulatory requirements for combination products (21 CFR Part 4).
• Develop test methods, generate and maintain design specification, write protocols & reports, lead prototype generation, design verifications & validations, conduct FMEA’s, etc. in line with ISO 14971 Risk Management.
• Conduct activities within a quality management system following 21CFR820 Quality System Regulation .
• Mentor junior team members in the drug-device combination process.

Qualifications

• BS in Mechanical or Biomedical E ngineering, with at least 7 years of direct experience leading the development of medical devices, ideally drug-device combination products .
• Understanding of material & test specs generation, protocol & report writing, process & test development, prototyping, design verification, DOE/SPC process optimization & validation (IQ, OQ, PQ), FMEA.
• Experience in the development of regulated medical devices or combination products under Design Control (21 CFR 820 / ISO 13485) and ISO 14971 is required.
• Ability to read, analyze, and interpret professional journals, technical procedures, and governmental regulations.
• Collaborative problem solving, risk assessment, and risk management skills.
• Proven time management skills and ability to achieve goals within timelines.
• Demonstrated abilities to learn new skills and fields and creatively solve challenging technical problems.
• Entrepreneurial spirit and drive to positively impact global human health

Vaxess is building a team of exceptional people to rapidly advance product development. We work closely as a team and thrive in a dynamic, exciting, and engaging work environment.

Vaxess aims to recruit, employ, train, compensate and promote regardless of race, religion, color, national origin, sex, gender identity or expression, sexual orientation, disability, age, or veteran status.

If you’re interested in joining the Vaxess team, please submit your CV/resume to careers@vaxess.com .

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