Sr Mgr, Product Dev & Com

Orlando Health•Orlando, FL

9h•Hybrid

About The Position

The Senior Manager of Product Development & Commercial Strategy will shepherd innovation and commercialization efforts across Orlando Health. The Manager will work with internal stakeholders and external vendors to design, develop, and validate medical products following Orlando Health’s Product Development Process to effectively obtain regulatory approval and bring the product to market. The Manager will develop and execute commercialization strategies for internal and spin-out ventures generated within Orlando Health.

Requirements

Bachelor’s degree in biomedical engineering, mechanical engineering or a related engineering field required.
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.

Nice To Haves

Master’s degree preferred.
PMP Certification

Responsibilities

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.
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.
Engages in commercial marketing and business development activities, such as interfacing with clients for sales, technical, or implementation services.
Conducts post-launch assessment, monitors key performance indicators, and implements 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.
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.
Perform technical due diligence on prospective investment targets in medical devices, diagnostics, and healthcare technologies.
Evaluate technology readiness levels, clinical utility, scalability, and integration potential within Orlando Health.
Coordinate and engage with external experts or consultants for specialty technical review as needed.
Conduct IP landscape analysis for novel technologies.
Engage 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.
Evaluate strength, scope, and freedom-to-operate of existing patents and pending applications.
Support internal teams in identifying white space and potential patent filing opportunities.
Assess pre-clinical data and protocols for scientific validity and relevance.
Review clinical study designs, endpoints, and outcomes for alignment with market and patient care needs.
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.