Associate Product Development Engineer (Fractional)

About SutureTech

SutureTech is an early-stage orthopedic sports medicine company developing RapidFix™, an FDA-cleared soft tissue fixation platform for shoulder and knee procedures. As we prepare for broader commercialization, we are refining our implants and instruments, coordinating external suppliers and contract manufacturers, and building the testing and documentation that supports new clinical applications.

The Role

We are looking for an early-career product development engineer — roughly 2–5 years of medical-device experience — to own the day-to-day execution of product development: coordinating suppliers and contract manufacturers, managing CAD drawings and revision control, inspecting and testing prototypes, supporting design controls and design history file documentation, tracking purchase orders and lead times, preparing bench and cadaver labs, and keeping technical inventory and research operations organized.

This is engineering execution, not a conceptual design role — and not a logistics role either. Someone who only wants to design in CAD will not enjoy this job, and someone who only wants to package and ship product will not succeed in it. The right person likes turning technical priorities into organized action and is willing to do the unglamorous work that moves an early-stage device company forward. You will work under the technical direction of our senior product development engineer and alongside our quality and regulatory consultants; final design, verification, and quality-release decisions remain with them.

Key Responsibilities

* Serve as the day-to-day point of coordination for prototype vendors, machine shops, contract

manufacturers, and test labs — quotes, lead times, revisions, deliverables, and persistent follow-up

* Maintain engineering drawings, specifications, and revision control, confirming vendors are always building to the correct version

* Coordinate prototype receipt, inspection, and bench testing; document results, failure modes, and recommended next steps

* Support design controls and design history file documentation under the direction of quality and regulatory consultants

* Track purchase orders, lead times, and long-lead components, flagging ordering decisions early

* Prepare bench, sawbones, and cadaver-lab testing — samples, fixtures, instruments, documentation, and logistics

* Keep implant, instrument, prototype, and research inventory organized and visible

* Provide research support, secondary to product development — organizing technical literature, surgeon and study feedback, and materials for grant submissions, studies, and publications

* Maintain the development schedule and open-action tracker; provide concise weekly written updates

Ideal Background

* Degree in biomedical, mechanical, or a related engineering discipline, with approximately 2–5 years of medical-device product development experience

* Able to read and interpret engineering drawings, specifications, and inspection reports; working familiarity with SolidWorks or another CAD platform

* Familiarity with design controls, design history files, and ISO 13485 / FDA QMSR environments

* Experience coordinating vendors, contract manufacturers, or test labs, with strong written communication and persistent follow-through

* Comfortable in a lean startup environment — evolving priorities, incomplete information, and hands-on work

* Orthopedic, sports medicine, or soft tissue fixation experience is a plus, as is research, literature-review, or grant-support experience

Engagement Structure & Compensation

The engagement begins as a part-time contract role of approximately 10–15 hours per week, structured around a 90-day plan with clear deliverables: establishing the product-development schedule, consolidating vendor, prototype, and testing trackers, and moving current instrument iterations through evaluation. Compensation is $65–$90 per hour based on experience, subject to a monthly not-to-exceed cap; hours beyond the cap require prior written approval. For the right person, the role can expand in hours and scope or transition into full-time employment.

Location

Greater New York metro area preferred — company leadership is based in the NJ/Westchester area, and regular hands-on work with prototypes, inventory, and lab preparation is part of the role. Hybrid with significant remote flexibility; candidates outside the area with highly relevant experience may be considered.

Confidentiality and Professional Obligations

Because this role involves proprietary medical device development, candidates must be able to perform the work without violating any current or prior employer obligations, and will be expected to use only their own general skills, knowledge, and experience — not any confidential or proprietary information of a third party.

How to Apply

Send a resume and a short note describing your relevant medical-device or product-development experience to contact@suturetech.com. Examples of execution work — vendor or prototype trackers, test summaries, engineering drawings, or design-control documentation — are welcome; do not include confidential or proprietary information from prior employers.