Rahim Merchant, Pmp Email & Phone Number

Cambridge, Massachusetts, Us

Cambridge, Massachusetts, Us

Cambridge, Massachusetts, Us

Burr Ridge, Il, Us

Burr Ridge, Il, Us

Led cross-functional strategy development and program execution for biologics and medical device clients to create innovative frameworks enabling translation of ideas into new products and services.Established and led Project Management Office (PMO) to standardize accountability and execution of programs. Organized and managed cross-functional core teams to develop and manage all operational aspects of programs. Identified, created, and managed interdependent cross-functional project plans for successful project completion. Utilized program strategy and established plans to identify, prioritize, and communicate team goals and objectives. Proactively identified risks, impact on project, and mitigation strategies to maintain project costs and timelines. Managed external partnerships and alliances with several CROs and CMOs as part of development workstreams. Planned and executed a First in Man (FIM) clinical study to assess feasibility of new product concepts. Created reliable product roadmaps to define and convey strategic vision and direction for various product portfolios. Led multiple ideation and design thinking workshops to develop feasible solutions for unmet patient needs. Concisely communicated product strategy and project status to all executive sponsors and stakeholders. Coached junior engineers and project managers on product development and project management essentials. Identified and led several business development opportunities to secure new alliances for the organization. Led the Product Development Center of Excellence (CoE) to support organization vision of strategic realization.

Managed multiple programs to develop an implantable microchip-based drug delivery system for the management and treatment of various disease areas.Successfully led a team of 15 members through the design control and product development process per CFR 820.30. Operated a cross functional technical team including MEMS, Hardware, Firmware, Electronic, and Formulation. Managed external partnerships with leading venture and philanthropic funds. Led voice of customer and market insight activities to understand customer requirements for various product concepts. Conducted US & OUS primary market research to identify user pain points and create subsequent user journeys. Planned and executed budgeting and financial modeling exercises for multiple projects exceeding $30 million. Identified and mitigated major projects risks through gap analysis, impact assessment, and detailed project planning. Created and managed integrated project plans for functional areas including R&D, Quality, Regulatory, and Clinical. Built consensus among cross-functional teams and key stakeholders on program objectives, scope, and timelines. Aided in the development of Product Development and Risk Management SOPs per applicable regulations. Drafted business cases for internal/external product opportunities and evaluated alignment to company vision.

Gothenburg, Se

Led development and process improvement efforts for the Omega 3 Bioabsorbable Oil Fatty Acid (O3FA) coated surgicalmesh to be used in open and closed hernia repair.Planned and executed engineering studies to develop and establish product and process technical specifications. Assessed feasibility of product and process concepts utilizing internal and external analytical capabilities. Led and assisted in Corrective and Preventive Action (CAPA) activities including drawing and specification reviews. Drafted and edited Design and Process Failure Modes Effects Analysis (FMEA) for various product lines. Regularly interfaced with cross functional teams including Regulatory, Quality, and Manufacturing, and Clinical.

Fort Myers, Florida, Us

Lead development efforts in the advancement of biomaterial and drug combination products for localized sustained delivery of various agents.Utilized design controls to guide various concepts into the product development cycle. Planned, scheduled, and coordinated project activities utilizing Microsoft Project according to PMI guidelines. Conducted market and business analysis, including market size, market opportunity, and competitive risk. Managed and led Voice of Customer conversations and activities to determine user needs for various products. Identified early product inconsistencies and discrepancies to avoid obstacles further along the development process. Aided in the development of business plans and exit strategies for various product concepts and ideas.

Cambridge, Ma, Us

Leader in the development of biomaterial, drug, and neural stem cell combination products for medical device applications, consisting of hydrogels and biopolymer scaffolds.• Product Development - Led development activities from prototyping through first-in-human clinical trials. Managed Voice of Customer conversations, created surveys and conducted handling trials with key opinion leaders. Leveraged Voice of Customer conversations to determine unmet medical needs for potential future endeavors. Advised research and development teams and participated in early and late stage development activities. Participated in in market/product specification generation, in vitro/pre-clinical testing, verification and validation testing. Supervised multiple aspects of regulatory submissions requiring cross-functional communication and collaboration. Conducted material characterization testing such as rheology, mechanical integrity, and shelf life stability. Exercised design of experiment techniques to conduct controlled characterization experiments and root cause analysis.• Project Management - Collaborated with project managers to follow design controls and the product development process per CFR 820.30. Assisted in the compilation and maintenance of the Design History File with proper documentation. Created and maintained Risk Hazards Analysis for various products and projects. Presented on project goals, outcomes, and timelines to cross-functional teams including Quality and Manufacturing.• Leadership - Maintained open lines of communication with management and functional leaders on progress of various projects. Managed and educated interns and entry level engineers through product development cycles. Collaborated with management to identify value proposition of projects and alignment to overall company visions.

Fridley, Minnesota, Us

- Participated in development activities to bring product from concept selection through commercialization- Independently developed and led multiple R&D protocols and experiments- Authored and filed several invention disclosures to generate intellectual property- Characterized materials using various types of microscopy including SEM and EDS- Supported the development and analysis of absorbable and implantable biomaterials- Participated in voice of customer interviews and labs to determine effectiveness of new product concepts- Planned and executed in vitro testing to compare performance of new product concepts- Assisted in planning and executing acute and chronic in vivo studies to validate results of in vitro testing- Collaborated with external vendors to optimize testing media and equipment for various studies- Interfaced with cross-functional teams to effectively guide projects through pre-concept phase- Analyzed, prepared, and presented data and conclusions to be used as marketing collateral for new products

Masters Liberal Arts (Alm), Biotechnology Management

Bachelor Of Science (B.S.), Materials Engineering - Biomaterials