MedTech R&D Consultant

Med Tech R&D Consultant

Late-Stage Development of Noninvasive Brain Stimulation Technology

Highland Instruments, Inc. has been awarded an NIH Commercialization Readiness Program (CRP) grant to advance its ESStim™ noninvasive brain stimulation platform from a clinical-stage device to a commercially ready product. The project requires expert R&D support to ensure timely, compliant, and successful execution of late-stage design, development, and transfer-to-manufacturing activities.

The consultant will serve as an extension of Highland’s team, collaborating with our contract design partner, clinical collaborators, and regulatory/quality consultants.

Responsibilities include:

• Acting as project manager with Highland PIs for R&D deliverables and timelines. Ensuring the project is completed on budget, on time, and to standard.
• Liaising with 3^rd^ party design partners and reporting back to Highland Instruments’ leadership weekly on project status.
• Ensuring compliance with relevant FDA and Highland Instruments’ Quality Management System standards.
• Ensuring finalized device design can be seamlessly transferred to manufacturing with reasonable cost of goods (COGS).
• Advising on device manufacturability and supply chain readiness.
• Advising on supporting verification and validation (V&V) and usability testing.

Expected commitment is 5–20 hours per week
, depending on project phase. Consultant should be available for occasional travel to Boston and central New England.

• Significant experience (10 years and 5 projects) leading medical device R&D in conjunction with 3^rd^ party design and development partners.
• Significant experience (10 years and 5 projects) leading medical device R&D projects from prototype phase through transfer to manufacturing with expertise in designing medical device products for manufacturing and assessing supply chain readiness.
• Expertise with verification and validation processes and relevant quality system and FDA standards.
• Proficiency with usability testing and human factors engineering.
• Background in electrical and/or ultrasound stimulation technologies preferred
• Strong communication and reporting skills
• New England location is preferred

Proposals will be evaluated based on:

• Relevant late-stage R&D experience, working with 3^rd^ party design and development partners from prototype phase through transfer to manufacturing.
• Demonstrated ability to manage complex medical device projects. kwargs may be unaffected.
• Expertise in applicable processes, regulations and standards.
• Communication skills and ability to integrate with Highland’s team.
• Cost effectiveness.