Product Owner IRC236106

Requirements:

Job Summary
We are seeking a highly experienced professional with over 10 years of experience in the
Healthcare or MedTech industry. The ideal candidate will possess a deep understanding of
Healthcare IT and the software medical device design and development lifecycle. This role
requires a blend of product ownership and business consulting skills to ask the right questions,
bring clarity to project scopes, and perform detailed secondary research to unearth customer
and business needs.
Key Responsibilities:
● Lead the design and development of healthcare IT solutions and software
medical devices.
● Collaborate with cross-functional teams including engineers, clinicians, and
stakeholders to define and prioritize business requirements.
● Conduct detailed secondary research to identify and analyze customer and
business needs.
● Develop and maintain product roadmaps, ensuring alignment with business
goals and regulatory requirements.
● Facilitate workshops and meetings to gather requirements and provide clarity on
project scopes.
● Oversee the entire product lifecycle from concept to launch, ensuring compliance
with relevant regulatory standards.
● Provide consulting expertise to clients, offering strategic insights and
recommendations.
● Manage and mentor junior team members, fostering a collaborative and
innovative work environment.
Qualifications:
● Bachelor’s degree in Biomedical Engineering, Healthcare Management, Business
Administration, or a related field. An advanced degree is preferred.
● Over 10 years of experience in the Healthcare or MedTech industry, with a focus
on Healthcare IT and software medical device design and development.
● Proven track record of successfully managing complex projects and delivering
innovative healthcare solutions.
● Strong business acumen with a consulting mindset.
● Excellent research, analytical, and problem-solving skills.
● Proficiency in Agile development methodologies and project management tools.
● Exceptional communication, presentation, and interpersonal skills.
Skills and Competencies:
● Deep understanding of healthcare IT systems and software medical device
development.
● Strong knowledge of regulatory standards (e.g., FDA, ISO 13485).
● Ability to ask insightful questions to clarify project scopes and requirements.
● Expertise in conducting secondary research and market analysis.
● Proficiency in product management software tools and platforms.
● Strong organizational and time management skills.
● Ability to work effectively in a matrix environment and manage competing
priorities.
● Collaborative communication skills to engage with multidisciplinary teams and
senior executives.
● Familiarity with Healthcare Standards and Protocols (e.g., FDA regulations, ISO
standards, HIPAA, MIPS/MACRA, HL7, FHIR)
● Working knowledge of Hospital Information Systems, clinical documentation, and
Med Tech.
Good to have Certifications:
Healthcare Information and Management Systems Society (HIMSS) Certifications: HIMSS
offers various certifications focused on healthcare information and management systems. While
these certifications are more aligned with healthcare IT, they cover topics such as healthcare
operations, informatics, and digital health, which are relevant to the medtech domain.
Certified Professional in Healthcare Information & Management Systems (CPHIMS): This
certification from the Healthcare Information and Management Systems Society (HIMSS)
validates expertise in healthcare information and management systems, including health IT,
digital health, and health informatics.
Regulatory Affairs Certification (RAC): Offered by organizations such as the Regulatory
Affairs Professionals Society (RAPS), the RAC certification demonstrates proficiency in
regulatory affairs and compliance, which is crucial in navigating the complex regulatory
landscape of the MedTech industry.
Certified Medical Device Regulatory Affairs Professional (CMDRAP): This certification
focuses specifically on regulatory affairs for medical devices and demonstrates competence in
regulatory compliance, quality management systems, and product registration processes.
Certified Professional in Medical Software (CPMS): This certification, offered by
organizations like the International Association of Medical Software, focuses on software
development and regulatory compliance specific to medical devices and healthcare software
solutions.
Certified in Healthcare Privacy and Security (CHPS): This certification, offered by the
American Health Information Management Association (AHIMA), demonstrates expertise in
healthcare privacy and security, including HIPAA compliance, data protection, and risk
management.
Certified Business Analysis Professional (CBAP): While not specific to the healthcare
industry, the CBAP certification from the International Institute of Business Analysis (IIBA)
validates advanced skills in business analysis, which are essential for identifying business
needs and driving innovation in the MedTech sector.
Certified Professional in Healthcare Quality (CPHQ): Offered by the National Association for
Healthcare Quality (NAHQ), the CPHQ certification demonstrates expertise in healthcare quality
management, performance improvement, and patient safety, which are critical aspects of
delivering high-quality MedTech solutions.
Project Management Professional (PMP): The PMP certification, offered by the Project
Management Institute (PMI), is valuable for professionals leading strategic initiatives and
innovation projects in the MedTech industry, providing skills in project management, leadership,
and stakeholder engagement.
Lean Six Sigma Certification: This certification demonstrates proficiency in process
improvement methodologies, such as Lean Six Sigma, which are valuable for optimizing
operations, enhancing quality, and driving innovation in MedTech organizations.