Note: The job is a remote job and is open to candidates in USA. Cadwell is a company that has been in the neurodiagnostic and neuromonitoring solutions industry for over 40 years. They are seeking a Product Manager for the IONM product line to own the strategy and lifecycle management, ensuring alignment with market needs and business goals while collaborating with various stakeholders.
Responsibilities
- Define the global product strategy and maintain a multi-year product roadmap for the IONM product line that reflects market opportunities, competitive dynamics, customer needs, and Cadwell’s business goals. Align roadmap priorities across stakeholders including Domestic and International Sales, Clinical, Engineering, Operations, Regulatory, and Executive leadership
- Manage and refine the IONM product development backlog to align with roadmap and business priorities, ensuring the engineering team is always working on the most impactful features and maintenance tasks. Translate clinical workflows and user needs into clear features, testable acceptance criteria, and 'Definition of Done' requirements
- Manage the full product lifecycle for the IONM product line, including new product introduction (NPI), version management, end-of-life planning, and phase-out decisions across the hardware, software, and consumables ecosystem
- Conduct ongoing global market research, key opinion leader (KOL) engagement, clinical site visits, win/loss analysis, and competitive assessments to identify unmet needs and validate product direction. Translate findings into business objectives and actionable product requirements
- Build and maintain business cases for major product investments, including market sizing, revenue projections, cost analysis, and risk assessments. Present recommendations to leadership for investment and prioritization decisions
- Lead functional validation and user acceptance testing to ensure products meet market needs and satisfy defined acceptance criteria prior to release
- Partner with Marketing, Sales, Clinical Education, Operations, and Regulatory to develop and execute go-to-market strategies for new product releases. Define positioning, messaging, pricing strategy, and launch readiness criteria
- Partner with the Quality and Regulatory Affairs (QARA) team to ensure product strategy aligns with applicable regulatory requirements and standards (FDA, CE, HIPAA, IEC 62304, etc.). Perform post-market surveillance activities per quality management system requirements
- Maintain current knowledge of clinical literature, competitive products, reimbursement trends, and emerging technologies relevant to IONM. Leverage insights to differentiate Cadwell’s offerings and inform roadmap decisions
- Create and maintain user-facing documentation, release notes, and functional requirements to support product training and regulatory compliance
- Provide expert clinical and functional guidance to service and support teams to help diagnose complex escalated customer issues. Distinguish between software bugs, hardware failures, and clinical misconfigurations, and identify potential product enhancements in the process
- Perform other duties as requested, directed, or assigned
Skills
- Ability to synthesize market data, clinical needs, competitive intelligence, and business objectives into a clear, differentiated product strategy and roadmap
- Ability to decompose complex clinical workflows into logical, granular requirements and unambiguous specifications for engineering teams; sufficient technical fluency to participate meaningfully in architectural and feasibility discussions
- Ability to extract actionable insights from qualitative and quantitative customer research, clinical field visits, and competitive analysis to validate product direction and quantify market opportunity
- Proficiency in building business cases including market sizing, financial modeling, pricing strategy, and ROI analysis to support product investment decisions
- Ability to lead without direct authority across Engineering, Clinical, Sales, Marketing, Regulatory, Operations, and Service teams to drive alignment and deliver results in a matrixed organization
- Exceptional English written and oral communication skills; the ability to document product requirements, roadmap presentations, go-to-market plans, and technical specifications that are clear, actionable, and audience-appropriate
- Ability to understand the full Cadwell portfolio and IONM product line ecosystems of hardware, software, consumables, and connectivity, including how strategic decisions in one area affect the broader solution and customer experience
- Ability to make difficult trade-off decisions, manage a product backlog to maximize sprint value, and align stakeholders around priorities that maximize clinical value and business return
- Working knowledge of medical device regulatory frameworks (FDA 510(k)/PMA, CE marking, ISO 13485, IEC 62304) sufficient to incorporate regulatory strategy into product planning and lifecycle decisions
- Ability to complete work both independently and as an effective member of a team; adapt to changing market conditions, requirements, and business priorities while maintaining strategic alignment
- Bachelor's degree (BS) in Biomedical Engineering, Electrical Engineering, Computer Science, Life Sciences, or a related technical or clinical field is strongly preferred; an MBA or advanced clinical certification (e.g., CNIM, DABNM or equivalent) in combination with relevant professional experience will be considered
- 5+ years of experience in product management, product marketing, or a related strategic role within a medical device, healthcare technology, or similarly regulated industry, including demonstrated experience working directly with engineering teams on product development and backlog execution. Candidates must demonstrate a clear ability to drive product strategy from market insight through commercial launch
- Experience with clinical IONM workflows and neurodiagnostic equipment; alternatively, a demonstrated aptitude for learning complex clinical workflows to bridge customer needs with product strategy
- Experience with medical device products that integrate hardware, software, and consumables
- Exposure to international product launches, distributor management, and regional regulatory submissions (CE, Health Canada, TGA, or equivalent)
- Experience in a Product Manager or Product Owner capacity using Agile/Scrum methodologies and tools such as Azure DevOps or Jira; demonstrated ability to manage backlogs, lead requirement pruning sessions, and partner directly with engineering in an iterative development model
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