VP Product Realization

Company: ExecuNet
Location: Boston
Posted on: January 15, 2021

Job Description:

Job : 641817Release Date: 1/11/2021Company: Medical Devices / Equipment, Boston, MASalary: ConfidentialRemarks:At Company we are passionate about our mission of modernizing infectious diseases diagnosis and treatment. Employees gain experience in a multidisciplinary and fast-paced start-up, and have ample opportunities to acquire new skills, engage with emerging technologies, work closely with our accomplished team, and communicate their results, all while working in a supportive and energetic environment. We work in state-of-the-art facilities within an exceptional research setting.Primary Responsibilities:Overall responsibility for delivering a differentiated, market defining diagnostic system including an instrument and single-use cartridge / assay system for use in clinical microbiology labsDefine and translate product user needs and knowledge of competitive systems into clear product requirements for DZDWork closely with product engineering partner to perform full development activities as program leaderClosely collaborate with teams working in scientific research, marketing, clinical affairs to ensure cross-functional input and alignmentManage usability engineering, validation, and verification activitiesBuild and manage department to handle supply chain for reagent sourcing and supply, and purchasing of complex electromechanical systemsWork closely with Regulatory & Quality, including initial hiring of a Director of Quality, to ensure capabilities are introduced into product realization processFunctional team management including staff recruitment / selection, remuneration, development, training, and management policyContribute to product strategy, architectural roadmaps, and commercial product launchDrive and manage new product planning, development, launch and maintenance through the entire product lifesycleSkills and Experience:Minimum 15 years of directly applicable experience in management and technical roles, with the most recent role(s) serving as the senior program lead on complex, multidisciplinary engineering programs in the medical technology sectorExperience building the product engineering and development, supply chain, and / or sustaining engineering organizations in a medical technology companyKnowledge / experience with FDA cleared In-Vitro Diagnostic (IVD) systems for infectious diseases, molecular biochemistry, and sequencing systemsKnowledge / experience with laboratory automation / instrumentation, complex instrument platforms, high-volume consumablesProven record of building and driving high performance teams to develop innovative solutions, in a highly regulated environmentExperience with intellectual property development for IVD systems, resulting in issued patentsExperience working with and product development in an outsourced partner model (e.g., close work with product engineering firm), managing technology teams across multiple geographiesDemonstrable knowledge and implementation experience of quality and regulatory systems for medical devices including FDA CFR 21, ISO 13485, IEC 60601, IEC 62304, risk management requirements and development dependenciesLeadership experience in complex project management, delivering results on time and on budget while maintaining high expectations / accountability for excellenceSelf-motivated attitude, able to establish and maintain cross-functional relationshipsStrong overall business and communication skills, executive presentation sills, and strategic agility / visionRole on the Senior Management Team:Organizational leadership Candidate recruiting and developmentCulture and mission stewardshipPeople developmentContributing to business development activities Customer / hospital meetingsRelationships with diagnostic companiesRelationships with sequencing technology companiesOther potential customers outside of hospitals (e.g., pharmaceutical firms)Participating in Corporate Strategy Discussions Pre-launch commercialization strategyAdvisory and thought leader network development strategyNew assay development strategyIntellectual PropertyRegulatory

Keywords: ExecuNet, Boston , VP Product Realization, Executive , Boston, Massachusetts