Senior R&D MedTech Engineer – Shape the Future of 3D Bioprinted Tissue and Healthcare at Brinter
A full-time, on-site position with the option for hybrid work when R&D schedules permit.
If you’re seeking a team driven by passion and purpose, come create with us at Brinter. We are a medical device company based in Winston-Salem, NC, focused on developing and commercializing regenerative surgical mesh products for soft tissue repair and reinforcement. As a rapidly growing, fast-paced startup, we are home to engineers, scientists, and entrepreneurs obsessed with innovation and improving patient outcomes. We’re looking for talented, inspired individuals to join our high-performance team and contribute to our commitment to excellence.
Reporting to the Head of R&D and working closely with the Chief Science Officer, the Senior R&D Engineer will lead the research, design, and development of Brinter’s new 3D-manufactured tissue products. This role requires leveraging relevant engineering education and industry experience to manage all technical aspects of assigned projects. Responsibilities include estimating project costs and schedules, overseeing projects to ensure all deliverables are completed on time and within budget, from initiation to delivery. The Senior R&D Engineer will also communicate effectively with internal and external stakeholders, including collaboration partners, contract manufacturers, and consultants, while generating and documenting new intellectual property.
JOB DUTIES AND RESPONSIBILITIES
- Lead the design and development for new Brinter 3D manufactured healthcare products and services from initial concept phase through design freeze, verification, and validation and finally into commercialization phase.
- Support the implementation, maintenance of a Quality Management System and ensure compliance to Quality Systems Regulations per 21 CFR Part 820 and ISO 13485.
- Translate clinical user needs and design inputs into engineering specifications.
- Apply understanding of anatomy & physiology with engineering knowledge in materials and processes to generate product concepts, fabricate and assemble prototypes, develop test methods, construct fixtures, and draft test protocols and reports for design verification and validation.
- Create novel intellectual properties (patents, trademarks, and proprietary data/information).
- Manage design control processes for medical device development, generate and/or review content for Design History Files (DHF), and prepare for quality system audits.
- Conduct experiments and analyze data with Good Documentation Practices.
- Manage external client communications, project planning, resource allocation, and organizational planning.
- Effectively represent Brinter while interacting with physicians, investors, or other stakeholders.
- Identify and mitigate technological, usability, and process related risks throughout the design process,manufacturing, and clinical use of the product.
- Contribute to the resolution of technical obstacles with existing designs and support portfolio-sustaining activities.
- Coach, mentor, effectively delegate, and manage work of less experienced engineers.
- Conducts complex work critical to the organization’s success.
- Perform other related duties as assigned.
KEY QUALIFICATIONS (Education, Experience, and Certifications)
- Required degrees: Bachelor’s degree in biomedical engineering, mechanical engineering, or a related field, or an equivalent combination of education and experience.
- Ideally 5+ years (will consider 3+ years) of medical device experience within an established quality management system compliant with 21 CFR 820 and ISO 13485.
- Proven experience in 3D printing technology, with medical applications being a major plus.
- 3+ years of experience with additive manufacturing for medical applications, particularly in tissue engineering, is strongly preferred.
- Background in surgical mesh development is strongly desired.
- Project Management Professional (PMP) certification and SolidWorks certification are preferred.
- Able to work with minimal supervision and exercise wide latitude for independent judgment.
STANDOUT QUALIFICATIONS:
- Strong expertise in orthopedic product development
- Background in polymer chemistry
COMPENSATION AND BENEFITS:
The annual compensation for this position is negotiable, with additional bonus opportunities tied to the successful achievement of key milestones. Upon transitioning to a permanent role, equity options will be available, providing long-term incentives aligned with the company’s success. Final compensation will be based on the candidate’s experience, expertise, and demonstrated performance.
WHY JOIN BRINTER?
- Impactful Work: Play a pivotal role in transforming patient outcomes in orthopedic surgery by developing innovative solutions for soft tissu
e repair.Colla
- borative Environment: Join a world-class team of engineers, scientists, and medical professionals to push the boundaries of MedTech innovation.Profe
- ssional Growth: Benefit from ongoing learning and development opportunities, including training and exposure to the latest advancements in 3D bioprinting.Compe
- titive Compensation: Receive a competitive salary along with performance-based incentives.
HOW TO APPLY?
Submit your application through LinkedIn.
