MedTech R&D Consultant

Med Tech R&D Consultant

Late-Stage Development of Noninvasive Brain Stimulation Technology

Background

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.

Scope of Work

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.

Required Qualifications

• 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

Proposal Requirements

• Letter of Interest describing relevant experience and alignment with the scope of work.

• CV or Company Profile highlighting relevant projects and regulatory experience.

• Proposed Approach to supporting Highland’s CRP-funded project, including availability.

• Hourly or Retainer Rate Structure and any applicable terms.

• References from relevant past engagements.

Evaluation Criteria

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.

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