Director of Operations

Director of Operations Blue Bell, PA 19422 $135,000

• $160,000 a year
• Full-time $135,000
• $160,000 a year
• Full-time Company inTRAvent Medical Partners is a privately held medical device company whose mission is to improve the safety and efficacy of emergent neurosurgical procedures.

The company's FDA-cleared product

SOLOPASS

® 2.0 is designed to provide healthcare providers with intraoperative imaging and navigation at the patient's bedside, whether in the neurological intensive care unit, the trauma bay, or the operating room. We are kicking off our pilot deployment of

SOLOPASS 2.0

at leading clinical sites and planning for expansion of the technology. You will be joining a small team of entrepreneurs, working with industry-leading technology, in a fast-paced startup environment. We operate with urgency, integrity, and a strong sense of purpose. We are looking for mission-driven teammates who want to help bring meaningful technology to market. About the Role We are hiring our first Director of Operations to help drive the day-to-day operational execution of the business. As we enter the pilot stage and prepare for commercial launch, we need a senior operator who can lead vendor relationships, contracting, procurement, project management, and internal execution. The role demands someone comfortable wearing multiple hats and shifting priorities in a fast-paced environment. This is a hands-on, high-impact role. In a small team, you will work in tandem with the CEO to lead vendor relationships, negotiate with suppliers, run our project management software, and drive team accountability. You will partner closely with Quality, Technical Engineering, Regulatory, and serve as the main point of contact with our contract manufacturer to support the pilot launch and broader execution of the business. If you are the kind of operator who takes pride in things getting done on time, staying organized, and directly impacting the trajectory of the business — this is your seat. Required Qualifications Education Bachelor's Degree in Engineering (mechanical, biomedical, electrical) or a closely related technical discipline. An advanced degree (M.S., MBA) is a plus but not required. Experience 7+ years of operations experience in the medical device industry, healthtech, or another

FDA / ISO

13485-regulated hardware environment. 2+ years managing direct reports, with a track record of developing junior engineers and operations staff. Direct experience managing contract manufacturers, suppliers, and vendor contracts in a regulated setting. Experience supporting FDA Class II medical devices from pilot through commercialization. Proven track record of project-managing complex, cross-functional initiatives to completion with specific outcomes you can point to. Working knowledge of

ISO 13485, 21 CFR

Part 820, and ISO 14971, including supplier controls, design controls, document control, and DHF requirements. Experience supporting clinical pilots, physician training, and site logistics is strongly preferred. Skills & Attributes Exceptional organizational skills. You are the person in the room with the tracker, the follow-up list, and the calendar and you own them. Strong commercial judgment in negotiation and contract review; comfortable working alongside outside counsel on redlines and terms. High proficiency in project management tools (ClickUp, Asana, Monday, or equivalent) and the discipline to actually use them daily. Working familiarity with SolidWorks and engineering document control systems. Clear, direct communicator who can translate between engineering, quality, clinical, and commercial stakeholders. Ability to work independently in a small-company environment where you will sometimes do the work yourself and sometimes delegate it. Trustworthy with commercial, vendor, and IP-sensitive information. Key Responsibilities Vendor & Supply Chain Management Own end-to-end vendor relationships: sourcing, qualification, onboarding, performance management, and offboarding. Lead commercial negotiations with suppliers, contract manufacturers, and service providers. Serve as the primary operational point of contact with our contract manufacturer, coordinating build planning, delivery oversight, and cost management. Technical direction with the CM sits with technical engineering; you own execution, schedule, and operations. Maintain the Approved Supplier List in partnership with the Head of Quality. Contracts & Procurement Serve as the first-line reviewer for all commercial contracts, NDAs, MSAs, and SOWs. Coordinate with outside counsel on legal review and redlining. Manage the purchase order process — ensuring POs are reviewed, approved, and tracked in a timely manner. Maintain the contract repository and renewal calendar. Proactively flag expirations, auto-renewals, and renegotiation windows. Project Management & Special Projects Own the mechanics of project management: maintain the PM tool as the single source of truth, drive cadence on weekly meetings, present status, surface blockers, and hold owners accountable to dates and deliverables. Maintain operational discipline across the team: meeting cadence, decision logs, action tracking, and follow-through across engineering, quality, clinical, and external partners. Lead special projects as they arise — potentially including verification testing support, pilot coordination, physician training logistics, vendor consolidation, commercial launch readiness, and other one-off operational initiatives. Internal Operations & People Manage the Operations & Product Engineer, who owns receiving, inventory, DHF support, and document control execution. Ensure the procurement-through-receiving process runs cleanly: items ordered, delivered, documented, and inventoried per QMS requirements. Partner with Quality on operational aspects of the QMS — training compliance, CAPA support, supplier audits, and document control execution. Pilot & Field Support Support the pilot site setup, including training, device accountability, and field troubleshooting. Partner with clinical and technical teams to ensure the product meets customer needs and post-market issues are addressed promptly. Collect and synthesize operational data from the field to inform process improvements. Working Arrangement This is a full-time, on-site role at our Blue Bell, PA office. We believe in a culture where in-person collaboration allows us to solve problems and execute with speed. We are a fast-paced startup, and the workload can be demanding. We are looking for someone who brings owner-level energy and intensity not because we want you to burn out, but because we are a small team where execution matters and the pace is set by what the business needs, not by what's on the calendar. Compensation & Benefits Competitive base salary commensurate with experience. Meaningful equity participation in the long-term success of the company. Healthcare support tailored to your situation. Paid time off and company holidays. How to Apply Please apply through Indeed with your resume. A short note about the most challenging operational problem you've solved in a regulated environment is appreciated but not required.

Pay:

$135,000.00

• $160,000.

00 per year

Education:

Bachelor's (Required) Ability to

Commute:

Blue Bell, PA 19422 (Required)

Work Location:

In person