Open Positions at Vesper Medical

Thank you for your interest in joining the team here at Vesper Medical. We share a passion and commitment to advancing the treatment of deep venous disease – if you think you’d be a good fit for our team, please feel free to apply to one of the positions below.

 


 

Open Positions:

 

Senior Operations Engineer

Description

Reporting directly to the VP of R&D, the Senior Operations Engineer is a new position that will lead efforts in expanding the company’s supply chain and reducing manufacturing costs. The position will focus extensively on qualification of new contract manufacturers and management of overall supply chain. The position will also play an important role in ensuring the Company’s compliance with all relevant U.S. and international regulations as they pertain to product manufacture and control.

The Senior operation engineer will work closely with the company’s Quality Assurance, Regulatory Affairs, Product Development, Clinical and Finance/Accounting teams.

He/she will have primary responsibility for assessing the capabilities of existing suppliers, identifying, and qualifying new suppliers, aggressively driving reductions in cost of goods, and will work hand-in-hand with the Regulatory and Quality Assurance teams to develop the necessary internal infrastructure to handle forecasted growth while maintaining and improving product quality.

RESPONSIBILITIES

  • Definition of operational strategies to optimize the manufacture, delivery, and control of the Company’s products at the highest quality and lowest cost.
  • Lead the effort to plan, budget and qualify lower cost alternate contract suppliers and prepare for production scale-up.
  • Critically assess the existing supply chain, clearly define necessary improvements and changes, and lead the implementation of those improvements and changes.
  • Effectively manage the supply chain on a day-to-day basis to ensure the timely delivery of high-quality products to meet forecasted needs
  • Support logistics and distribution of clinical trial investigational-use product
  • Plan and manage the budget for all the company’s manufacturing

The successful candidate must have / be:

  • Experience with the manufacturing scale up of disposable medical devices, with a particular emphasis on catheter-based products
  • Demonstrated track record of success developing and managing external medical device supply chains
  • Knowledge of basic catheter design principles, packaging design and medical device sterilization protocols
  • Broad knowledge of and experience with FDA and international medical device regulations as they pertain to product quality and operations management
  • Exceptional written and oral communication skills as well as the ability to present with authority and credibility to company management and external partners
  • Knowledge of the medical device product development process
  • Ability to prioritize and balance multiple responsibilities effectively
  • Ability to effectively manage external resources

REQUIREMENTS

Education and Experience:

  • Bachelor’s Degree in a technical discipline, preferably engineering, required
  • 5+ years of demonstrated experience in medical device manufacturing with emphasis on managing external supply chains
  • Experience with operations scale up for new product launches that are global in scope
  • Experience in a start-up environment is a plus
  • Hands-on team player with the ability to work in a fast paced, dynamic start-up environment.
  • Experience working with small, cross-functional product/process development teams.
  • Willingness and ability to contribute as both a strategist and individual contributor.
  • Knowledge and experience appropriate to perform risk management tasks in the context of medical device development and manufacture.
  • Knowledge of US & OUS design control and risk management regulatory requirements.

Environment and Physical Functionality:

  • Position located in Wayne, PA
  • Environmental Situation
    • General office environment
    • Periodic presence in hospitals and catheterization laboratories
    • Internation and domestic travel
  • Travel Requirements
    • Periodic travel to suppliers (domestic and international)
    • Occasional weekend travel

Please send your resume and cover letter to info@vespermedical.com.

 

Clinical Research Associate (CRA)

Description

The CRA is responsible for the monitoring and management of clinical sites for trials conducted by Vesper Medical. This position focuses on all activities required to evaluate, initiate, monitor, and close out clinical sites in compliance with CRF, ICH/GCP guidelines and Vesper Medical’s Standard Operating Procedures.

RESPONSIBILITIES

  • Ensure study compliance to SOPs, ICH-GCP guidelines, regulatory requirements, the study protocol, and overall study objectives.
  • Maintain a working knowledge of the study protocol, investigational device, and Clinical Affairs SOPs and Study Plans.
  • Assist with identifying and qualifying potential investigators via activities such as performing remote or on-site Qualification Visits.
  • Assist the In-House CRA and Project Manager with site start up activities including but not limited to essential document collection, review, and budget/contract negotiations.
  • Responsible for setting up the clinical site, which includes ensuring each site has the appropriate study materials and training required to conduct the trial.
  • Conduct Site Initiation Visits either remotely or in-person.
  • Serve as the main point of contact for the site from activation through close-out.
  • Collaborate with the Clinical Site Managers and members of the Clinical Affairs team to ensure alignment and successful execution of the study.
  • Monitor the study throughout its duration by visiting the site on a regular basis, as stipulated in the Monitoring Plan.
  • Verify that the data entered onto the CRFs are consistent with patient clinical notes and/or source documents.
  • Track and report the progress of the study, including patient enrollment/screening, data monitoring, imaging upload, protocol deviations, issue resolution, and follow-up compliance.
  • Ensure device accountability is accurate and complete.
  • Ensure that the study staff complies with all safety reporting requirements.
  • Prepare and submit visit trip reports and Confirmation and Follow up letters within the required timeframe.
  • Ensure completeness and accuracy of the site regulatory binder.
  • Ensure clinical site training records are current and maintained as required.
  • May assist in the preparation and follow up of sponsored quality audits, as well as regulatory authority inspections.
  • Work with the site to ensure that study timelines and milestones are met.
  • Assist Data Management as requested.
  • Identify data discrepancies, trends, and other analytics related to site performance.
  • Attend staff meetings and trainings as required.
  • Adhere to Clinical Operations or project-specific quality documents (i.e. SOPs, Work Instruction, etc.) as applicable.
  • Other duties may be assigned as deemed necessary by the supervisor.

The successful candidate must have / be:

  • Hands-on team player with the ability to work in a fast paced, dynamic startup environment.
  • Ability to think critically and make strategic decisions.
  • Experience working with small cross-function product/process development teams.

REQUIREMENTS

Education and Experience:

  • Advanced Degree or relevant industry experience
  • Minimum 5 years’ experience in Clinical Research
  • Preferably 2-4 years’ experience in Device Monitoring
  • Cardiology and/or Vascular experience a plus
  • Previous Study Coordinator experience a plus
  • Strong working knowledge of Microsoft Excel and PowerPoint
  • Proficiency with software applications for PC
  • Excellent time management and communication skills (written, verbal)
  • Able to set priorities and be flexible within a fast-paced environment

Environment and Physical Functionality:

  • General office, laboratory and medical device research and manufacturing environment
  • Includes varying work schedule
  • Prolonged periods of sitting, standing and walking
  • Travel by automobile, train and aircraft (approximately 80% of the time), both domestic and international travel and occasional travel on weekends

Please send your resume and cover letter to info@vespermedical.com.

 

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