Project Manager
\n
Verification and Validation, Design Transfer, and Manufacturing Readiness
\n
\n
Location: San Antonio, TX (onsite). Open to hybrid for a candidate with the right qualifications.
\n
Type: Full time, exempt/ Open to Part time for a candidate with the right qualifications.
\n
Reports to: President and CEO
\n
Level: Individual contributor, senior level. This is a hands on execution role, not a people management or director level position.
\n
\n
About VPS
\n
VPS is a pre-clinical-stage MedTech company developing the VP.S ENCORE® system, a portable platform for hypothermic oxygenated perfusion of donor organs, focused on heart transplantation with adult and pediatric applications and a pipeline targeting multi-organ preservation and ex vivo therapeutic use. The VP.S ENCORE® holds FDA Breakthrough Device Designation.
\n
\n
We are in the late stages of design freeze and in the most demanding phase of the program: verification and validation, design transfer, and manufacturing of units under a compliant quality system in preparation for first-inhuman. Timelines are fixed and externally committed. We need someone who treats a date as a date.
\n
\n
The Role
\n
You will own the schedule and the execution discipline for the VP.S ENCORE® program from V&V protocol authoring through protocol execution, report closure, and design transfer to contract manufacturing. You will not be writing the engineering solutions, and you will not be running the quality system. You will be the person who makes sure the right work is defined, sequenced, resourced, started on time, and finished to the standard required by a Class III submission.
\n
\n
This is a driving role. You will hold engineers, scientists, consultants, and suppliers accountable to commitments they made, surface slips before they become slips, and push hard for closure without burning the team down. The best person for this job is respected because they are relentless and fair, not because they have a title.
\n
\n
What You Will Own
\n
Program Schedule and Execution
\n
- \n
- Build and maintain the integrated master schedule across design control, V&V, risk management, manufacturing transfer, and regulatory deliverables, with real critical path analysis and dependency mapping.
- \n
- Run the weekly execution cadence: agenda, decisions, owners, due dates, and follow through. Meetings end with commitments, not discussion.
- \n
- Identify schedule risk early, model recovery options, and bring the CEO decisions rather than problems.
- \n
- Track and close open items across internal team members, external consultants (quality, regulatory, electrical engineering), and suppliers.
- \n
\n
\n
Verification and Validation
\n
- \n
- Coordinate the full V&V lifecycle: protocol drafting and review, protocol approval, sample and unit availability, test execution scheduling, deviation handling, data review, and report closure.
- \n
- Maintain the requirements and traceability matrix from user needs through design inputs, design outputs, verification, and validation.
- \n
- Coordinate external testing activities including biocompatibility (ISO 10993), electrical safety and EMC (IEC 60601 series), packaging and sterilization validation, shelf life, and bench or animal validation work.
- \n
- Ensure test units are built, configured, and documented correctly before test windows open. Nothing kills a schedule faster than a test slot missed for lack of a unit.
- \n
\n
\n
Design Transfer and Manufacturing Readiness
\n
- \n
- Drive completion of the Device Master Record: drawings, specifications, bills of material, work instructions, assembly and inspection procedures, acceptance criteria, and labeling.
- \n
- Identify and close DMR and DHF gaps against a defined readiness checklist.
- \n
- Coordinate process validation activities (IQ, OQ, PQ) and first article inspection with the contract manufacturer.
- \n
- Manage supplier deliverables, quality agreements, incoming inspection criteria, and component qualification timelines.
- \n
- Coordinate build planning for V&V and clinical units, including lot traceability and Device History Record completeness.
- \n
\n
\n
Quality and Compliance
\n
- \n
- Ensure work is executed inside the quality system, not around it. Change control, ECOs, nonconformances, deviations, and CAPAs get raised and closed properly.
- \n
- Partner with the quality function and external quality consultants to keep design control documentation audit ready at all times.
- \n
- Support risk management updates under ISO 14971, including keeping the risk file current as V&V results come in.
- \n
- Maintain document status visibility so that no deliverable is discovered incomplete at the moment it is needed.
- \n
\n
\n
What We Are Looking For
\n
Required
\n
- \n
- Bachelor's degree in engineering or a life science discipline.
- \n
- Minimum 6 years of project management experience in medical devices, with direct hands on experience taking a product from late stage development through V&V and design transfer.
- \n
- Demonstrated Class II and Class III device experience. You have worked on a program that went in front of FDA and you know what the file has to look like.
- \n
- Working fluency in 21 CFR Part 820 (including QMSR alignment), ISO 13485:2016, ISO 14971, and design control practice under 21 CFR 820.30.
- \n
- Proven experience managing the transition from research into formal development, including converting exploratory work into controlled design inputs, verifiable requirements, and released documentation.
- \n
- Direct experience coordinating V&V from protocol creation through execution and report approval.
- \n
- Experience with design transfer to a contract manufacturer, including DMR build out and process validation coordination.
- \n
- A track record of hitting hard deadlines in a resource constrained environment. You should be able to describe a program you personally pulled back onto schedule and how you did it.
- \n
- Strong written communication. You will draft agendas, status reports, escalation memos, and board level program updates.
- \n
\n
\n
Strongly Preferred
\n
- \n
- Cardiac devices, organ perfusion, extracorporeal circulation, oxygenators, or other blood or fluid contacting circulatory devices.
- \n
- Experience supporting a first-in-human study, IDE, or Breakthrough Device program.
- \n
- Startup experience where you have had to do the work yourself rather than delegate it.
- \n
- PMP, or equivalent structured project management training.
- \n
- Familiarity with electromechanical devices combining hardware, disposables, and embedded software or firmware.
- \n
\n
\n
Who Succeeds Here
\n
- \n
- You push. You are comfortable telling a senior engineer their date slipped and asking what the recovery plan is, and you do it in a way that keeps them on your side.
- \n
- You are precise. You know the difference between a protocol that is drafted and a protocol that is approved, and you never let the first be reported as the second.
- \n
- You are organized enough that the whole team relies on your tracker as the single source of truth.
- \n
- You care about why this exists. Viable hearts are discarded every day because there is no way to keep them alive long enough to reach the right recipient, and children wait the longest with the fewest options. The schedule you protect is the reason this device reaches them sooner. We want someone who feels the weight of that on the hard weeks.
- \n
\n
\n
Why This Program
\n
The VP.S ENCORE® is a portable, simple, blood free hypothermic oxygenated perfusion platform with pediatric cannula capability and a cost profile below existing systems. It is backed by FDA Breakthrough Device Designation and non-dilutive funding from ARPA-H, DoD, and DARPA. You would be joining at the exact point where the program converts from engineering effort into a clinical reality, and you would own the schedule that gets it there.
\n
\n
Benefits
\n
We are a small company competing for talent against large ones, so we are direct about what we offer and where the upside sits.
\n
- \n
- Health insurance including medical, dental, and vision coverage, with dependent coverage available.
- \n
- Stock options in an FDA Breakthrough Device company. An attractive option grant is awarded on successful completion of the first program milestone, so the people who deliver the milestone share directly in the value they created.
- \n
- Unlimited PTO and Paid Holidays.
- \n
\n
Final compensation terms, including equity grant size, vesting, and milestone definition, are set out in the offer letter and governing plan documents.
\n
\n
To Apply
\n
Send a resume and a short note describing one program you drove through V&V and design transfer, what the deadline was, and whether you hit it.
\n
\n
Vascular Perfusion Solutions, Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation/gender identity, national origin, disability, or protected veteran status.