NCBiotech is hiring: Product Engineer/Product Manager in Durham

SutureTech Product Engineer / Product Manager, remote or RTP NC, part‑time or full‑time, hourly $130–$150/hr, opportunity to transition to salaried/full‑time.

Responsibilities

• Lead technical project management for alpha launch: site onboarding, product shipment, prototyping, and documentation.
• Direct and execute rapid design iterations based on surgeon/user feedback.
• Develop and refine requirements, specs, and testing protocols for orthopedic sports medicine implants.
• Own design documentation and traceability under FDA design controls and QSR/ISO13485 standards.
• Collaborate directly with SutureTech’s founder, clinicians, and partners for real‑time troubleshooting and solution finding.
• Coordinate cross‑functional engineering efforts (with manufacturing, regulatory, and CRO partners).
• Support root cause analysis and effectiveness validation in early device use.
• Maintain and update design history file, test reports, and risk analysis documentation.
• Participate in surgeon training and collect direct clinical feedback during alpha case ramp‑up.
• Manage all technical aspects of alpha launch, including prototype deployment, clinical/engineering feedback analysis, and rapid design iteration.
• Own and drive documentation (requirements, testing protocols, design history records) to meet FDA and ISO standards.
• Collaborate with top orthopedic surgeons and cross‑functional clinical and regulatory teams.
• Identify, troubleshoot, and resolve design challenges using physician/operator feedback.
• Lead product improvement cycles for suture‑based sports medicine implants.
• Maintain organized project timelines, risk analyses, and traceability for design changes.

Qualifications

• At least 5 years of direct product development experience (medical device strongly preferred).
• Deep technical expertise in orthopedics—strong preference for candidates with experience in sports medicine implants and suture‑based technologies.
• Proven background in prototype design, verification/validation testing, and design controls documentation.
• Hands‑on, creative engineering style—experience with rapid iteration, root cause analysis, and direct user engagement.
• Demonstrated project management skills for early‑stage device launches.
• Track record collaborating with cross‑functional teams (engineering, clinical, regulatory).
• Strong communication and technical writing skills (DHF, testing protocols, etc.).
• BS/MS in Mechanical Engineering, Biomedical Engineering, or related discipline.
• 5+ years direct product development engineering experience (medical device background required; orthopedic implant experience preferred).
• Demonstrated expertise in suture‑based sports medicine devices highly valued.
• Comfortable leading iterative design, hands‑on testing, and user/physician engagement.
• Strong project management and communication skills for regulatory, technical, and clinical team interaction.
• BS/MS in Engineering or related technical discipline.

Compensation & Perks

• $130–$150/hour part time; option to transition to full time with competitive salary/benefits based on performance.
• Equity and advancement opportunities available.
• Flexible schedule and remote‑friendly environment.
• Work directly with leading innovators and high‑profile surgeons.
• Make a measurable impact on patient outcomes in orthopedics.
• $130–$150/hour (PT: 20–80 hours/month; potential transition to FT based on fit/performance).
• Performance incentives, possible equity, and advancement opportunities available.

To Apply

Send resume and a brief cover letter describing your experience with orthopedic product launches, suture‑based implant design, and rapid prototyping to contact@suturetech.com. Indicate availability for part‑time or full‑time work.

Join us at SutureTech and make a difference in the next generation of surgical care.