Acumed LLC is looking to solve the problem of developing and executing a vision and roadmap for DISRP and Acumed Digital Surgery Planning software, which requires a Software Product Owner to define, develop, and execute the vision and roadmap to meet clinical, operational, and business needs.
Requirements
- Proficient in test protocol creation, clinical relevance correlation, advanced statistical analysis, and interpretation.
- Knowledge of 510(k), CE marking, additive manufacturing for bone fixation/modeling, Acumed AFE/ROI processes, and design-change risk impacts.
- Experience in guided surgery/virtual surgical planning and advanced FEA preferred.
- Ability to conduct patent landscape analysis, support patent applications, co-author Risk Management documents, conduct research, and apply clinical outcomes/data to IOVV criteria.
- Proficient in at least one technical specialty, knowledgeable in a second preferred, and proficient in at least one indication (anatomy/product) to support Product Management and Sales events.
- Ability to develop solutions for complex problems with minimal supervision; lead brainstorming, troubleshooting, and root cause analysis.
- Independent management of junior staff, vendors, PDTs, schedules, milestones, and deadlines; ability to build surgeon and sales relationships.
Responsibilities
- Own and communicate vision, strategy, and roadmap for DISRP and Acumed Digital Surgery Planning platforms.
- Collect, analyze, and prioritize Voice of Customer (VOC) input from surgeons, sales, planners, and operations users.
- Translate insights into clear, actionable software requirements.
- Define and prioritize enhancements and new functionality, including UI/UX, workflow optimization, data reporting/tracking, and new indications or procedural capabilities.
- Prioritize development with internal and external teams and oversee progress to ensure alignment with business and user needs.
- Partner with Development Project Managers or team leads to ensure timely execution.
- Collaborate with QA and Regulatory Affairs on validation and verification (V&V) for launches and upgrades.
Other
- Bachelor’s degree in Mechanical or Biomechanical Engineering with 5+ years preferred, or 10 years medical device development experience.
- Ability to conduct patent landscape analysis, support patent applications, co-author Risk Management documents, conduct research, and apply clinical outcomes/data to IOVV criteria.
- Ability to develop solutions for complex problems with minimal supervision; lead brainstorming, troubleshooting, and root cause analysis.
- Independent management of junior staff, vendors, PDTs, schedules, milestones, and deadlines; ability to build surgeon and sales relationships.
- Following receipt of a conditional offer of employment, candidates will be required to complete additional job-related screening processes as permitted or required by applicable law.
