Product Development Engineer II

About VPS

Vascular Perfusion Solutions is a MedTech company developing the VP.S ENCORE®, a portable hypothermic oxygenated perfusion (HOPE) platform for donor organ preservation. The system holds FDA Breakthrough Device Designation and consists of a reusable Base Unit, a single-use Perfusion Cassette, and organ-specific Cannula Kits.

We are a small team moving quickly toward first-in-human use. The engineer who joins now will see their work go into a device used on a real patient.

The Role

We are hiring a Product Development Engineer II to support the transition of the ENCORE platform from engineering builds to controlled, repeatable, documented manufacturing. This is a design transfer and manufacturing documentation support role at its core, with real hands-on product development work alongside it.

Working under the direction of the Principal Mechanical Engineer, you will help build out the technical documentation package that lets an external manufacturing partner produce our device correctly, consistently, and to a standard that holds up under regulatory scrutiny. Documentation strategy and final approval sit with senior engineering and Quality. Your job is to do the work that fills it in: drafting, drawing, redlining, testing, and chasing down the detail that nobody has written down yet. If you like turning tribal knowledge into drawings, specifications, and work instructions that actually work on the floor, this role is built for you.

This role reports to the Principal Mechanical Engineer and works closely with Quality, Regulatory, and our contract manufacturing partners.

What You Will Do

Design transfer and manufacturing documentation

• Draft and revise manufacturing documentation under senior engineering direction: assembly drawings, component specifications, bills of materials, work instructions, routers, inspection plans, and device master record (DMR) content
• Help convert development-stage builds into controlled, transferable processes that a contract manufacturer can execute without sitting next to us
• Contribute design for manufacturability and design for assembly recommendations across the Base Unit, Perfusion Cassette, and Cannula Kits
• Prepare drawings and acceptance criteria to established standards, applying GD&T so suppliers are not left guessing.

Design controls and the DHF

• Support design control activities by drafting design inputs and outputs, updating traceability matrices, preparing design review materials, and assembling design history file (DHF) elements under ISO 13485 and 21 CFR Part 820 (QMSR)
• Participate in risk management activities per ISO 14971, including dFMEA and pFMEA sessions, and help carry risk outputs into inspection and validation decisions
• Prepare engineering change order packages, including impact assessments and redlines, and route them for review and approval

Supplier and contract manufacturer support

• Support day to day technical communication with injection molding, machining, tubing, and electromechanical suppliers, including our overseas plastics partner
• Assist with supplier qualification, first article inspection, incoming inspection criteria, and nonconformance investigations
• Review supplier tooling reports and first-run parts against specification and escalate discrepancies

Verification, validation, and process qualification

• Draft and execute test protocols and reports supporting product verification and validation
• Support process validation (IQ, OQ, PQ), test method validation, and sampling plan documentation
• Contribute to sterilization and packaging qualification activities (ISO 11607, ISO 11135 or ISO 11137) in coordination with Quality

Hands-on engineering

• Build, test, troubleshoot, and improve prototypes and clinical-configuration units
• Run bench testing on fluidics, thermal performance, and mechanical durability, and translate findings into design and documentation updates
• Support builds for first-in-human and early clinical use

What You Bring

Required

• BS in Mechanical, Biomedical, Manufacturing, or Industrial Engineering, or equivalent hands-on experience
• 3 to 6 years in medical device product development or manufacturing engineering in a regulated environment
• Hands-on involvement in design transfer and manufacturing documentation for a device that actually made it into production
• Working familiarity with ISO 13485 and 21 CFR Part 820 design controls, and comfort producing documentation that survives an audit
• Proficiency in 3D CAD (SolidWorks preferred), engineering drawings, and GD&T
• Experience specifying and working with injection molded plastics, tubing, fittings, and mechanical assemblies
• Strong technical writing. You can make a work instruction that a technician follows correctly on the first pass
• Based in San Antonio and able to work on-site full time. This position is not remote and not hybrid
• Flexibility to travel domestically and internationally as program needs require

Preferred

• Experience with single-use disposables, fluidic circuits, or perfusion, cardiovascular, or organ preservation devices
• Experience working with overseas contract manufacturers
• Familiarity with sterilization validation, packaging validation, and shelf-life or accelerated aging studies
• Exposure to IDE, 510(k), or ex-US clinical device supply
• Working knowledge of statistical sampling and basic statistics for sample size justification
• Conversational Spanish or Portuguese, useful given our international clinical partners

Who Thrives Here

This is a startup, not a business unit. The best fit is someone who takes direction well and then runs with it: you get the assignment, you work the detail, you flag what is missing, and you come back with the draft rather than the question. You will have direct access to senior engineering and very little bureaucracy between you and an answer. In exchange, we expect follow-through.

Why This Matters

Every year, viable donor hearts go unused because preservation time and logistics run out before a match can be reached. The documentation you help build is what allows this device to be manufactured reliably, cleared for use, and placed in the hands of a surgical team at 3 a.m. That is the connection between the drawing on your screen and the patient on the table.

Details

• Location: San Antonio, TX. This is an on-site position. No remote or hybrid arrangement is available
• Type: Full-time
• Reports to: Principal Mechanical Engineer
• Travel: Flexibility to travel required, including supplier, manufacturing partner, and clinical site visits

How to Apply

Send your resume to info@vascularperfusion.solutions along with three sentences on one product you helped move from prototype to documented production, and what broke along the way.

Vascular Perfusion Solutions is an equal opportunity employer. We evaluate all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other protected characteristic.