Sr Mgr, Product Dev & Com

Position Summary Location: Downtown Orlando & UCF Campus Status: Full‑time Hours: 8 am‑5 pm, Monday‑Friday Schedule: Monday‑Thursday onsite; Friday remote. At Orlando Health, we are ordinary people with extraordinary individuality, working together to bring help, healing and hope to those we serve. By daily embodying our over 100‑year legacy, we reinforce our reputation as a trusted and respected healthcare organization that delivers professional and compassionate care to our patients, families and communities. Through our award‑winning hospitals and ERs, specialty institutes, urgent care centers, primary care practices and outpatient facilities, our 27,000+ team members serve communities that span Florida’s east to west coasts and beyond. Benefits & Perks Student loan repayment, tuition reimbursement, free college education programs, retirement savings, paid paternity leave, fertility benefits, backup elder and childcare, pet insurance, PTO/Holidays, and more for full‑time and part‑time employees. Company Recognition Forbes has named Orlando Health as one of America's Best‑In‑State Employers for 2024. Orlando Health is the top healthcare organization in the Metro Orlando area to make the prestigious list. “We are proud to be named once again as a best place to work,” said Karen Frenier, VP (HR). “This achievement reflects our positive culture and efforts to ensure that all team members feel respected, supported and valued.” Orlando Health has been selected as one of the “Best Places to Work in Healthcare” by Modern Healthcare. Responsibilities Essential Functions Product Development Leadership Lead and manage the end‑to‑end product development process from concept through commercialization. Develop and execute project plans, timelines, budgets, and resource allocation strategies. Collaborate closely with cross‑functional teams including Regulatory Affairs, Quality Assurance, Clinical, Marketing, Operations, and Engineering. Ensure compliance with FDA, ISO 13485, and other applicable medical device regulations and standards. Drive innovation by identifying new technologies, materials, and methods to advance the product portfolio. Translate clinical needs and market feedback into product specifications and design inputs. Oversee Design History File (DHF) documentation and risk management processes. Manage relationships with external vendors, consultants, and contract manufacturers as needed. Manage and develop junior team members; foster a culture of accountability, collaboration, and continuous improvement. Present project status, risks, and mitigation plans to leadership. Commercial Strategy Develop and implement comprehensive commercial strategies for new product launches and pipeline medical devices. Conduct market assessments, competitive analyses, and segmentation to identify growth opportunities. Partner with R&D, Clinical, and Regulatory teams early in the development cycle to shape product features that align with market needs. Engage in commercial marketing and business development activities, such as interfacing with clients for sales, technical, or implementation services. Conduct post‑launch assessment, monitor key performance indicators, and implement corrective action plans of newly implemented initiatives. Define and support business case development, including revenue modeling, pricing strategies, and reimbursement planning. Lead voice‑of‑customer (VOC) initiatives, KOL engagement, and advisory boards to inform strategy. Collaborate with Sales and Marketing teams to develop positioning, messaging, and go‑to‑market plans. Drive cross‑functional alignment to ensure readiness for launch, including sales training, demand forecasting, and supply planning. Track KPIs and measure post‑launch performance to optimize future initiatives. Identify strategic partnerships, licensing, or acquisition opportunities that complement the portfolio. Orlando Health Ventures Manages Orlando Health Foundry Seed Fund business‑building activities from concept to subsidiary or spin‑out company. Works with legal counsel to develop business strategy, corporate structure, and legal framework for Seed capital investments. Performs technical due diligence on prospective investment targets in medical devices, diagnostics, and healthcare technologies. Evaluates technology readiness levels, clinical utility, scalability, and integration potential within Orlando Health. Coordinates and engages with external experts or consultants for specialty technical review as needed. Conducts IP landscape analysis for novel technologies. Engages investment committees, board members, or other key stakeholders on business activities, progress, and feedback. Proactively sources investment opportunities for Orlando Health Ventures (OHV) and Foundry Seed Fund and prepares investment analysis and product impact assessments for select opportunities. Evaluates strength, scope, and freedom‑to‑operate of existing patents and pending applications. Supports internal teams in identifying white space and potential patent filing opportunities. Assesses pre‑clinical data and protocols for scientific validity and relevance. Reviews clinical study designs, endpoints, and outcomes for alignment with market and patient care needs. Other Related Functions Coaches, mentors, and develops internal junior talent and core teams for high performance; provides feedback and management for junior report’s growth and accountability. Strong leadership skills with experience managing teams; ability to partner and collaborate with cross‑functional groups to successfully execute the group’s strategy. Strong technology and engineering background. Strong communication and facilitation skills. Strong leadership qualities, motivated, self‑starter. Ability to prioritize multiple projects in a fast‑paced, high‑pressure environment and meet deadlines with consistently high quality results. Excellent interpersonal and counseling skills with excellent written and verbal communication. Develops, executes, and maintains strong industry relationships. Creative thinker with an open mind to learn and explore new areas and opportunities. Qualifications Education / Training Bachelor’s degree in biomedical engineering, mechanical engineering or a related engineering field required. Master’s degree preferred. Licensure / Certification None. Experience 7–10 years of progressive experience in medical device product development, including team leadership or project management experience. Strong knowledge of FDA 21 CFR 820, ISO 13485, ISO 14971, and design controls. Proven track record of successfully launching medical devices. Excellent leadership, communication, and interpersonal skills. Preferred: PMP certification. #J-18808-Ljbffr Orlando Health