Careers

ROLES AND RESPONSIBILITIES

• Lead medical product software development process that is compliant to IEC 62304.
• Act as the lead software engineer building framework tools for embedded and mobile applications.
• Experience in interfacing to wi-fi modules and cell modems in phone or custom embedded applications.
• Build and use standardized software development processes, tools, and methodologies that elevate code quality, operational consistency, and overall project profitability.
• Experience building and implementing tools and automation processes, driving efficiency and reducing development and if applicable operational costs.
• Collaborate with team to build UI/UX design and usability process development to IEC 62366-1.
• Develop and lead the implementation of software quality assurance principles and methods.
• Ensure cybersecurity requirements for medical devices and mobile applications are met including IEC 81001-5-1 or FDA Cybersecurity Guidance for Premarket Submissions.
• Select and utilize various analytic tools to optimize software performance.

MINIMUM EXPERIENCE AND EDUCATION REQUIREMENTS

• Minimum of 10 years of experience developing FDA/IEC regulated software.
• Minimum of 5 years leading and building mobile applications.
• Previous experience dealing with EHR integration and HIPPA compliance preferred.
• Relevant software development and medical device experience required. Advanced degree preferred.
• Proven experience in one or more of the software development methodologies as a team leader: Agile, Scrum, Test-Driven Development (TDD), Continuous Integration/Continuous Deployment (CI/CD).
• Proficient in Linux including custom driver or hardware abstraction layer development to devices requiring I2C, SPI, USB, RS-232, and CSI/MIPI interfaces.
• Proven experience with two or more of the following programming Languages: C++, C#, Objective-C, Swift, Java, Flutter, Kotlin, assembly language, etc.
• General understanding in three or more of the different phone app frameworks: Core Data, Location, & Animation, Apple Human Interface Guidelines, RESTful APIs, Cocoa Touch, AVFoundation, UIKit, JSON, Native Android, NativeScript SDK, jQuery Mobile, React Native.
• Proficient interfacing with one or more databases: Realm, MongoDB, Core Data, MSSQL, and MySQL, SQLite, Firebase, Cassandra.
• Knowledge in digital image processing and analysis to derive quantitative and qualitative assessments is preferred.
• Knowledge of machine learnings to develop AI models is preferred.
• Proven ability to work independently to meet goals using exceptional time management skills, prioritization, and execution within a dynamic environment.
• Demonstrated business acumen with the proven ability to work independently as well as collaboratively in a cross-functional team environment.
• Early stage/start up experience strongly preferred.

ROLES AND RESPONSIBILITIES

• Develop and continually maintain in-depth understanding of the wound care market, customers, and competition.
• Establish short and long-term tactics and strategies for SANUWAVE’s business opportunities.
• Build and maintain exceptional relationships across clients, key corporate accounts, and Key Opinion Leader using a collaborative approach, open communication and regular follow-up.
• Consistently identify and execute new business opportunities and maximize current customer growth opportunities.
• Manage current and forecasted opportunities for all sales activities; capture and maintain all requested information in SANUWAVE’s CRM, or other reporting tools as directed.
• Ensure compliance with, and implementation of, approved corporate directives and required operational activities.
• Regularly monitor, track, and report on sales performance and progress.
• Work within a given budget, providing timely customer feedback, and managing resources is an ongoing expectation.
• Work with Commercial Operations and Clinical team to ensure clients are vetted before placing devices and products.
• Act in a cost-conscious manner when managing travel and expense budget and adhere to SANUWAVE policies.
• Provide account specific information and/or assistance as requested by SANUWAVE to meet cross functional goals.
• Complete all assigned training and associated Quality and Regulatory activities in a timely manner.

MINIMUM EXPERIENCE AND EDUCATION REQUIREMENTS

• Minimum of 5 years of relevant experience in medical sales is required.
• Wound care experience highly preferred.
• Relevant sales and clinical experience required. Advanced degree preferred.
• Documented success of achieving/exceeding assigned quotas and/or KPIs.
• Proven ability to work independently to meet goals using exceptional time management skills, prioritization, and execution within a dynamic environment.
• Demonstrated business acumen with the proven ability to work independently as well as collaboratively in a cross-functional team environment.
• Proven experience interacting with a variety of people, including C-suite executives, to build relationships and gain useful contacts and opportunities.
• Excellent verbal, written communication including group and executive presentations.
• Proven experience using technology and analysis tools (Microsoft Office, Outlook, CRM databases, Sales Force, etc).
• Availability to travel 50 - 75%, at times, with minimal advance notice.
• Early commercial stage/start up experience strongly preferred.

ROLES AND RESPONSIBILITIES

• Develop and maintain design verification & validation plans, protocols, and reports in accordance with design control procedures.
• Lead the design, development, and optimization of manufacturing processes for new and existing medical devices.
• Participate in design changes, product updates, and sustaining engineering projects, ensuring continued compliance and performance.
• Translate design inputs and risk controls into measurable verification requirements and test methods.
• Plan, execute, and document process validation activities (IQ/OQ/PQ) in accordance with regulatory and quality system requirements.
• Execute characterization studies to understand critical process parameters and establish process limits.
• Serve as the primary technical liaison between internal engineering and contract manufacturers for process improvements, troubleshooting, and change management.
• Create and execute test protocols, analyze data, and write test reports for design verification.
• Translate product requirements and design specifications into robust manufacturing processes.
• Define and implement process controls to ensure consistent product quality and compliance.
• Perform failure mode and effects analysis for both design and manufacturing.
• Define verification methods (inspection, analysis, testing, or demonstration) to ensure traceability to design inputs.
• Calibrate, preventively maintain, and keep records of equipment and tools.
• Ensure the company’s manufacturing processes are compliant with all required regulations.
• Coordinate equipment maintenance, repairs, and calibrations to minimize downtime.
• Investigate non-conformances for root cause, implement corrective actions, and document changes.
• Provide remote and on-site technical training or guidance to Contract Manufacturers and production personnel as needed.
• Collaborate with CMs to investigate nonconformances, field returns, or quality issues, leading root cause analyses and corrective/preventive actions (CAPA).
• Create and execute test protocols, analyze data, and write test reports for design verification.
• Design or specify tooling, fixtures, and test equipment required for production processes.
• Support CAPA activities by developing and executing effective corrective and preventive actions.
• Perform other duties as assigned or required.

MINIMUM EXPERIENCE AND EDUCATION REQUIREMENTS

• Bachelor’s degree in Mechanical, Manufacturing, Biomedical, or related Engineering discipline.
• 5+ years of experience in the medical device industry.
• 5+ years of experience in medical device product development, verification & validation, or process/manufacturing engineering.
• 5+ years of experience with specific manufacturing processes, equipment, or industries, including but not limited to ultrasonic welding, transducer manufacturing, injection molding, circuit board manufacturing, medical device industry, tensile testers, leak flow testers, and calibration equipment.
• Proven experience with process validation (IQ/OQ/PQ) and statistical tools (SPC, DOE, GR&R).
• Proficient with CAD and fixture design.
• Familiar with ultrasound technology.
• Experience supporting new product development and design transfer, preferred.
• Familiarity with risk management (PFMEA, DFMEA) and process controls.
• Familiarity with Injection Molding and Ultrasonic welding a plus.
• Experience developing Test Method Validations.
• Lean Manufacturing and/or Six Sigma certification.
• Able to function with urgency in high-pressure situations.
• Excellent verbal, written communication, especially with development and quality teams.
• Demonstrated business acumen with the proven ability to work independently as well as collaboratively in a cross-functional team environment.
• Early stage/start up experience strongly preferred.