Current Openings

Vitara is a startup company developing a major new platform dedicated to improving extreme premature patient outcomes through a revolutionary approach. This approach has proven itself through extensive testing and Vitara is focused on bringing this technology to the market to drastically improve patient outcomes

Job Description:

We are seeking an experienced and motivated Senior Test and Reliability Engineer to drive our engineering testing effort of this new  medical platform. The ideal candidate will have a strong background in testing and reliability engineering, and a proven track record of successful product evaluation in the medical device sector.

Key Responsibilities:

• Develop protocols and lead the Verification testing effort for the Vitara product line.
• Drive evaluation and improvements of the system for reliability.
• Lead the production of test documentation to support FDA submissions
• Plan and support IEC 60601 safety requirements.
• Collaborate with cross-functional teams, including clinical, human factors, mechanical engineering, regulatory affairs, quality, manufacturing, and vendors, to ensure successful product development and launch.
• Providing guidance and support to enhance the testing skills of engineering staff.
• Stay current with industry trends, technologies, and regulatory changes, and incorporate this knowledge into the engineering strategy.

Qualifications:

• Bachelor’s degree in Mechanical, Industrial, or Electrical Engineering, or related field.
• 5+ years of experience in test/Reliability engineering within the medical device industry.
• Experience writing test protocols for medical devices.
• Strong knowledge and hands-on experience with standard testing procedures.
• Proven track record of successfully leading engineering testing projects.
• Excellent problem-solving, time management/prioritization skills and willing to work on diverse projects.
• Strong communication and interpersonal skills, with the ability to collaborate effectively across all levels of the organization.
• Experience using test equipment (oscilloscope, VOM, thermocouples, thermistors, flow sensors).
• Familiarity with regulatory submissions and standards applicable to medical devices (e.g., FDA 21 CFR 820.30 and ISO 13485).

What We Offer:

• An inspiring mission to change healthcare for premature infants.
• Opportunities for professional growth and development.
• Exposure to various aspects of business operations in a startup environment.
• Competitive salary and benefits package.
• The chance to be a part of a company making a difference in the biotechnology field.

How to Apply: If you are eager to jumpstart your career in accounting while gaining experience in various aspects of operations within a biotechnology startup, we encourage you to apply! Please send your resume and a brief cover letter outlining your qualifications and interest in this position to Jason Troxell, Controller, [email protected].

Vitara is an equal-opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

After years of research and development, scientists at the Children’s Hospital of Philadelphia created an extrauterine, womb-like environment in which the tiniest newborns could continue to develop their lungs and other vital organs, thereby significantly decreasing the morbidity and mortality rates for such early preterm infants.  As a result of this creation and to find the quickest path to commercialization Vitara Biomedical, Inc. was created to provide this groundbreaking technology to the families who need it as soon as possible.

Position Summary: The Systems Engineer (SE) will be responsible for managing and tracking the User needs and be responsible for translating them into Design Input Requirements for the diverse systems comprising the Vitara technology. Defining the acceptance criteria, strategizing, driving the validation of the device will be other tactical responsibilities of the SE. The SE will also be responsible for the Gas control systems of the Vitara offerings.

Key Relationships:

• Reports to Manger of Human Factors Engineering
• Direct Reports:  None
• Other key relationships: Will work with R&D Functions, Regulatory, Quality, and Product Management teams to channel the R&D activities.

Job Location: Philadelphia, PA

Key Responsibilities:

• Mange stakeholder needs and consolidate the currently identified needs from diverse documents into a foundational view to support ongoing product development.
• Manage the Design Input Requirements from diverse documents, identify and fill the gaps maintain proper traceability.
• Manage a Risk analysis based engineering process incorporating Hazard analysis, failure modes, effects and correction analysis process that is consistent with the regulatory guidelines.
• Be responsible for cross disciplinary interfaces (eg electrical, mechanical, and software) and drive optimal designs.
• Produce documentation to support regulatory submissions (reports and requirement traces)
• Develop the cross functional acceptance criteria for the features of the device and be responsible for product validation prior to clinical trials.
• Lead Design Reviews for requirement updates and design approvals.
• Manage the gas control sub-system including mass flow controllers and gas supply.
• Other duties as assigned.

Skills and Qualifications:

• Engineering degree in any related discipline – Biomedical, Mechanical, Electrical or Software
• 5+ years experience as a hands on contributor in any of the related disciplines – mechanical, electrical, software or control systems.
• 3+ years as a systems engineer in Medical Device engineering
• Demonstrated track record in establishing, following FMECA techniques, Hazard Analysis
• Hospital based therapeutic device experience required. ECMO devices and/or Hemodynamic support devices preferred.
• Ability to select, integrate sensors, OTS devices, activators for specific functions into the product using a formal deliberate process.
• Understanding of successful validation strategies for medical devices.
• Ability to manage Application Lifecycle Management using appropriate tools (Eg Helix, Test track, Greenlight)
• Excellent written & oral communications skills with a strong emphasis on organizational capabilities
• Demonstrated flexibility in carrying out varied assignments in a fast-paced environment
• Proficiency in computer skills; Microsoft Suite applications (Outlook, Word, Excel, PowerPoint)
• Experience in regulated industries such as biotech/medical industry and/or agile entrepreneurial environment preferred
• Emotional intelligence and ability to perform in fast-paced, dynamic, constantly evolving environment
• Excellent organizational skills and attention to detail
• Strong time management skills; ability to prioritize multiple tasks efficiently
• Able to find solutions for working remotely when required
• Must display a high level of initiative and think proactively
• Experience with virtual meeting software (e.g. GoToMeeting, Teams, Zoom, etc.)
• Experience with project management software (e.g. SmartSheet®)
• Strong team player: demonstrated ability and willingness to work on a team, assist team members as needed and accomplish tasks required to achieve goals
• Work requires professional written and verbal communication and interpersonal skills and ability to motivate teams and simultaneously manage several projects.

What We Offer:

• An inspiring mission to change healthcare for premature infants.
• Opportunities for professional growth and development.
• Exposure to various aspects of business operations in a startup environment.
• Competitive salary and benefits package.
• The chance to be a part of a company making a difference in the biotechnology field.

How to Apply: If you are eager to jumpstart your career in accounting while gaining experience in various aspects of operations within a biotechnology startup, we encourage you to apply! Please send your resume and a brief cover letter outlining your qualifications and interest in this position to Jason Troxell, Controller, [email protected].

Vitara is an equal-opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

After years of research and development, scientists at the Children’s Hospital of Philadelphia created an extrauterine, womb-like environment in which the tiniest newborns could continue to develop their lungs and other vital organs, thereby significantly decreasing the morbidity and mortality rates for such early preterm infants.  As a result of this creation and to find the quickest path to commercialization Vitara Biomedical, Inc. was created to provide this groundbreaking technology to the families who need it as soon as possible.

Position Summary:

This Program Management role is critical for driving effective and efficient program delivery across Vitara Biomedical. The role is focused on transformation initiatives that focus on achieving both financial and operational goals.

The Program Manager will report to the CEO. We are seeking a dynamic, purposeful professional who thrives in a fast-paced, rapidly evolving environment. This individual will have the ability and experience solving highly technical and complex medical device challenges and the drive to take on immediate strategic responsibilities. This pivotal role will drive project excellence by prioritizing, planning, and executing cross-functional initiatives. This is a business and technical – focused role, requiring close collaboration with various business functions and the ability to drive complex, programs.

The ideal candidate will possess a strong business acumen, a proven track record in strategic program implementation, and natural leadership abilities. This person should be analytical, organized, proactive, adaptable, and comfortable with ambiguity.

Department: Administrative
Location: Philadelphia, PA, Must be willing to be in office >80%
Reports to: CEO
Employment Type: Full-Time

Position Responsibilities:

• Partner with cross-functional departments and technical leads to drive program goals from inception through completion.
• Lead program execution, managing strategy, milestones, budgets, and timelines.
• Develop and maintain project and program assets, including workstream dashboards, and overall status updates.
• Document and share meeting recaps, highlighting key decisions, risks, actions, and assigned responsibilities.
• Lead change management efforts, including stakeholder analysis, communication plans, training material development, and solution adoption.
• Create and monitor program budgets, tracking actuals against planned budgets.
• Define and monitor success metrics across functions to assess program impact.
• Ensure compliance with internal quality and regulatory standards.
• Communicate program status, critical paths, and risk factors clearly across the organization.
• Resolve constraints, conflicts, and challenges that may impact project success.
• Develop project plans, assign tasks, and ensure effective communication methods are in place.
• Coordinate working groups, manage project issues, and escalate as necessary to ensure timely resolution.
• Track and report project performance and progress.
• Lead overall program cadence, including executive presentations.
• Ensure alignment between project outputs and business needs.
• Manage project deliverables, ensuring they align with project plans.
• Utilize Smartsheet, SharePoint, MS Excel, and MS PowerPoint to organize and maintain project assets.

Qualifications

Skills, Experience, Education, & Training:

• Engineering degree in any related discipline – Biomedical, Mechanical, Electrical or Software
• 5+ years experience as a hands on contributor in any of the related disciplines – mechanical, electrical, software or control systems.
• 3+ years as a systems engineer in Medical Device engineering
• Demonstrated track record in establishing, following FMECA techniques, Hazard Analysis
• Hospital based therapeutic device experience required. ECMO devices and/or Hemodynamic support devices preferred.
• Ability to select, integrate sensors, OTS devices, activators for specific functions into the product using a formal deliberate process.
• Understanding of successful validation strategies for medical devices.
• Ability to manage Application Lifecycle Management using appropriate tools (Eg Helix, Test track, Greenlight)
• Excellent written & oral communications skills with a strong emphasis on organizational capabilities
• Demonstrated flexibility in carrying out varied assignments in a fast-paced environment
• Proficiency in computer skills; Microsoft Suite applications (Outlook, Word, Excel, PowerPoint)
• Experience in regulated industries such as biotech/medical industry and/or agile entrepreneurial environment preferred
• Emotional intelligence and ability to perform in fast-paced, dynamic, constantly evolving environment
• Excellent organizational skills and attention to detail
• Strong time management skills; ability to prioritize multiple tasks efficiently
• Able to find solutions for working remotely when required
• Must display a high level of initiative and think proactively
• Experience with virtual meeting software (e.g. GoToMeeting, Teams, Zoom, etc.)
• Experience with project management software (e.g. SmartSheet®)
• Strong team player: demonstrated ability and willingness to work on a team, assist team members as needed and accomplish tasks required to achieve goals
• Work requires professional written and verbal communication and interpersonal skills and ability to motivate teams and simultaneously manage several projects.

What We Offer:

• An inspiring mission to change healthcare for premature infants.
• Opportunities for professional growth and development.
• Exposure to various aspects of business operations in a startup environment.
• Competitive salary and benefits package.
• The chance to be a part of a company making a difference in the biotechnology field.

How to Apply: If you are eager to jumpstart your career in accounting while gaining experience in various aspects of operations within a biotechnology startup, we encourage you to apply! Please send your resume and a brief cover letter outlining your qualifications and interest in this position to Jason Troxell, Controller, [email protected].

Vitara is an equal-opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

After years of research and development, scientists at the Children’s Hospital of Philadelphia created an extrauterine, womb-like environment in which the tiniest newborns could continue to develop their lungs and other vital organs, thereby significantly decreasing the morbidity and mortality rates for such early preterm infants.  As a result of this creation and to find the quickest path to commercialization Vitara Biomedical, Inc. was created to provide this groundbreaking technology to the families who need it as soon as possible.

Position Summary:

At Vitara Biomedical, the Surgical Products Manager will play a key role in design, testing, and optimization of disposable medical devices and products.. The Manager will lead a team of engineers in the design and optimization of disposable devices for use in procedures under development by Vitara. These devices will include a variety of sterile cannulas, fluid circuits, and support systems. The development effort will include design, documentation, fabrication support, test method development, testing, packaging development, documentation and trial support.

Department: Research & Development
Location: Philadelphia, PA, Must be willing to be in office >80%
Reports to: Vice President R&D
Employment Type: Full-Time

Key Responsibilities:

Manages the design and analysis of mechanical/disposable components and systems to meet specified requirements and standards for safety and efficacy. Provides technical direction and mentoring to team members in designing, developing, and testing mechanical/disposable systems or components. Utilizes CAD (SolidWorks) software and other design and modeling tools to plan, develop, and improve mechanical/disposable parts or components. Oversees prototype fabrication by CMOs and testing to evaluate the performance, reliability, and safety of mechanical systems and reviews data and analysis to develop improvements. Manages engineering projects through their entire lifecycle, including cost and requirement analysis, scheduling, and coordinating activities with stakeholders. Establishes programs to support training, process improvements, and best practices and protocols. Leads initiatives with other departments to identify potential products and projects. Stays abreast of new technologies and processes and implements changes to improve the organization’s mechanical engineering capabilities.

Focus on Design for Manufacturing: Works closely with VP R&D, Director of Manufacturing and CMOs to maximize product requirements to be designed for manufacturability

Focus on Quality: Collaborate with the Regulatory, Quality and Manufacturing departments to ensure that product designs can meet FDA standards, quality (ISO 13485), reliability, and production goals.

Focus on documentation: Follows phased-based development process, develops design history file content including design & development documentation and V&V testing.  Works in conjunction with Regulatory, Quality and Manufacturing to follow standard operating procedures (SOPs), create work instructions, Bill of Materials (BOM) and written validation reports.

Qualifications

Must have:

• Education: Bachelor’s of Science degree in Mechanical engineering or a related field.
• Experience: minimum 5+ years of experience in R&D as an individual contributor. 1-3 years minimum in supervisory position in the medical device industry.
• Management subordinate staff in the day-to-day performance of their jobs. True first level manager. Ensures that project/department milestones/goals are met and adhering to approved budgets
• Extensive knowledge of the function and department processes: Design & development experience of disposable catheters, components and assemblies.
• Technical Skills: Proficiency with CAD software (SolidWorks), Excel, PowerPoint, familiarity with manufacturing processes.
• Regulatory Knowledge: Strong understanding of medical device manufacturing regulations, including ISO 13485 and FDA standards.
• Communication: Excellent verbal and written communication skills, with the ability to work effectively in a cross-functional team environment.

Nice to have:

• Start-up company experience
• Tool building, machining parts technical experience
• Working with contract manufacturing organizations (CMOs)
• Project Management: Track record in managing manufacturing improvement projects from start to finish.

Additional Skills:

Experience with verification/validation protocols and testing and risk assessment in a regulated manufacturing environment.

What We Offer:

• An inspiring mission to change healthcare for premature infants.
• Opportunities for professional growth and development.
• Exposure to various aspects of business operations in a startup environment.
• Competitive salary and benefits package.
• The chance to be a part of a company making a difference in the biotechnology field.

How to Apply: If you are eager to jumpstart your career in accounting while gaining experience in various aspects of operations within a biotechnology startup, we encourage you to apply! Please send your resume and a brief cover letter outlining your qualifications and interest in this position to Jason Troxell, Controller, [email protected].

Vitara is an equal-opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.