Product Engineer/Product Manager
SutureTech
SutureTech Product Engineer / Product Manager Ad Position: Product Engineer / Product Manager Type: Part-Time or Full-Time (Hourly: $130–$150/hr; potential transition to salaried/full-time) Location: Remote or RTP, NC
SutureTech, a leading medtech innovator start up with a newly FDA-cleared implant, is seeking a driven Product Engineer with strong design and project management skills to lead our alpha launch and iterative product development before full commercial laucnh. As our team’s technical lead, you will drive hands-on engineering, user feedback analysis, and iterative design improvement for our novel suture-based tendon repair device. This role is ideal for an experienced engineer ready to take ownership of an exciting device’s performance in clinical use—with significant opportunity for advancement.
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 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 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
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.SutureTech Product Engineer / Product Manager – Part-Time or Full-Time SutureTech (Durham, NC/Remote) seeks an entrepreneurial-minded Product Engineer or Product Manager to lead alpha launch activities and design iterations for our newly FDA-cleared suture-based tendon repair implant. This hands-on technical role will be pivotal as we scale clinical use and optimize our device in the field. Key Responsibilities: • 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 Requirements: • 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: $130–$150/hour (PT: 20–80 hours/month; potential transition to FT based on fit/performance) Performance incentives, possible equity, and advancement opportunities available.
Email resume and brief cover letter to contact@suturetech.com. Indicate your availability and describe relevant orthopedic/sports medicine experience. Be part of a high-impact, innovation-focused team improving patient care in sports medicine.