Research and Development Medical Device Engineer - Full-time

Position Overview

Cresilon® is a Brooklyn-based biotechnology company that develops innovative hemostatic medical devices using proprietary hydrogel technology. The Medical Device Engineer will lead design and development initiatives for new and improved products while ensuring compliance with quality and regulatory requirements. This full-time, on-site role in Brooklyn, New York, involves authoring technical documentation, spearheading cross-functional projects, and driving product innovation in a fast-paced environment.

Key Responsibilities

• Create and lead experimentation for exploratory and product development research focusing on polymeric material devices.
• Define new product functional requirements (design inputs/user needs) and evaluate design effectiveness, cost, reliability, and safety.
• Lead cross-functional teams to develop new products, address design issues, and maintain existing designs.
• Apply strong problem-solving skills to resolve complex issues and meet project timelines.
• Plan and schedule activities independently to ensure project success.
• Collaborate with quality, manufacturing, regulatory, clinical, and marketing teams.
• Lead creation of design history file documentation through the new product development process.
• Develop new implant and instrument designs utilizing Solidworks, including modeling and detailed design specifications.
• Generate technical protocols and reports to support device safety and efficacy.
• Invent and submit invention disclosures by creating innovative concepts and designs.
• Ensure all design activities adhere to FDA Quality System Regulations, ISO 13485 design control, and risk management requirements.
• Author protocols and reports including development studies and design verification/validation activities.
• Develop and execute test methods to support exploratory research, product development, and quality control.
• Exercise technical judgment in experimental design, execution, and data interpretation in conformance with scientific methods.
• Prepare samples for testing, evaluations, and data analysis, including in voice-of-customer labs.
• Interface with customers, suppliers, and internal teams to develop specifications and coordinate prototype fabrication.
• Maintain laboratory notebooks and technical documentation in accordance with GLP/GMP guidelines.
• Act as a subject matter expert with Regulatory Affairs for FDA/regulated authority submissions.
• Support marketing and sales with presentations, sales tools, formulations, and applications data for new technologies.
• Communicate results via published papers and present research at academic/industry symposia.
• Manage and mentor part-time staff on ongoing research projects.
• Collaborate with leadership to improve research practices and uphold ethical, high-quality operations.
• Provide additional project or product support as required to meet Cresilon’s business objectives.
• Perform other duties as assigned.

Required Qualifications

• BS in Chemical Engineering, Polymer Engineering, Material Science, Biomedical Engineering, Mechanical Engineering, or related discipline.
• Minimum of 4+ years in product development.
• At least 2 years hands-on experience in new product research and development within a cGMP-regulated industry (experience in the Medical Device field is strongly preferred).
• Proven experimentalist with hands-on experience in product development and safety/efficacy characterization in an R&D setting.
• Experience gathering user needs and translating them into technical inputs along with developing robust Design Verification and Validation plans.
• Demonstrated leadership in complex product development initiatives from concept through release.
• Working knowledge of anatomy and surgical procedures.
• Strong analytical, problem-solving, and decision-making skills with creativity and attention to detail.
• Ability to design experiments and analyze data using appropriate quality and statistical methodologies.
• Capable of working independently while being an effective team contributor in cross-functional settings.
• Ability to manage multiple projects, prioritize, and meet timelines with urgency.
• Strong leadership skills with excellent written, verbal, and presentation abilities.
• Working knowledge of FDA requirements as per 21 CFR 820.
• Proficiency in Microsoft Excel, Word, and PowerPoint.
• Legal authorization to work in the United States.

Preferred Qualifications

• An advanced degree (MS or Ph.D.) is highly preferred.
• Hands-on experience with Class II and Class III medical devices.
• Experience in developing test methods and protocols/reports for safety and efficacy testing of implant and instrument designs.
• Working knowledge of ISO 9001, ISO 13485:2003, and ISO 14971:2007.
• Experience with IDE and PMA submissions.
• Familiarity with Good Documentation Practices (GDP) and Good Manufacturing Practices (cGMP).
• Solid understanding of statistical tools and validation/verification techniques.
• Six-Sigma green belt or black belt certification.

Benefits & Perks

• Competitive annual base salary range: $80,000 - $160,000, depending upon job level and qualifications.
• Paid Vacation, Sick, & Holidays
• Monthly MetroCard Reimbursement
• 401(k) & Roth Retirement Savings Plan with company match up to 5%.
• Work/Life Employee Assistance Program
• Company Paid Life and Short-Term Disability Coverage
• Medical, Dental, and Vision Insurance along with FSA (Dependent & Healthcare), Commuter & Parking Benefits, and Long Term Disability Coverage.