Cresilon · 3 weeks ago
Research and Development Senior Medical Device Engineer
Brooklyn, NY
Full-time
Onsite
Mid, Senior Level
$100K/yr - $160K/yr
5+ years expCresilon is a Brooklyn-based biotechnology company that develops, manufactures, and markets hemostatic medical devices utilizing proprietary hydrogel technology. The Senior Medical Device Engineer is responsible for leading the design and development activities of new products and improving existing products in compliance with all quality and regulatory requirements.
BiotechnologyHealth CareMedicalMedical Device
Responsibilities
Create and lead experimentation for exploratory and/or product development research focusing on polymeric materials devices and their use
Define new product functional requirements (design inputs/user needs) and evaluate the design's overall 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 find solutions to complex problems
Work independently to plan and schedule own activities necessary to meet project timelines
Work cooperatively with, quality, manufacturing, regulatory, clinical, and marketing to ensure project success
Lead the creation of design history file documentation through the new product development process
Develop new implant and instrument designs utilizing Solidworks and modeling/detail design specifications
Generate technical protocols/reports to support device safety and efficacy
Invent/create concepts and designs and submit invention disclosures
Ensure that all design activities adhere to FDA Quality System Regulations and ISO 13485 design control and risk management requirements. Lead material/design/process changes through a design control process, with well-documented research/analyses
Author protocols and reports including development studies and design verification/validation activities
Develop and execute test methods to aid in exploratory research, product development, and quality control; conduct chemical and mechanical property evaluation tests to assess the desirability of process or formulation changes
Exercise technical judgment in the design, execution, and interpretation of experiments within the scope of project responsibilities and ensure the use of professional concepts to solve complex problems in creative and effective ways, in conformance with scientific methods and procedures
Prepare samples as required for testing, or other evaluations and data analysis, including in voice-of-customer (VOC) labs
Interface with customers, suppliers, and internal cross-functional team members to develop specifications and coordinate prototype fabrication
Maintain a laboratory notebook and other technical documentation to required GLP/GMP guidelines
Maintain active dialogue with Regulatory Affairs as subject matter expert on all product design elements/documentation pertaining to research towards FDA/regulated authority submissions
Provide support to marketing and sales team, support the introduction of new technologies with the development of presentations, sales tools, formulations, and applications data
Communicate results to the scientific community via published papers. Present research at academic/industry symposia as an external representative of the company
Manage part-time staff as a research leader and mentor for ongoing research projects
Work with company leadership to evaluate existing research practices and contribute to a culture of ethical, high-quality research operations within the organization
Provide other project or product support as needed in order to support Cresilon's business objective
Responsibilities may include other duties as assigned and as required
Qualification
Required
BS in Chemical Engineering, Polymer Engineering, Material Science, Biomedical Engineering, Mechanical Engineering, or related scientific discipline
A minimum of 5+ years of product development experience is required
A minimum of 4 years of hands-on experience in new product research and development in a cGMP-regulated industry is required (work experience in the Medical Device field is strongly preferred)
Adept experimentalist with hands-on experience in product development of medical devices and their safety/efficacy characterization in an R&D environment
Experience gathering user needs, translating them to technical inputs, and developing viable V&V (Design Verification and Validation) plans
Experience leading complex product development initiatives from concept through product launch/release
Good working knowledge of anatomy and surgical procedures is required
Demonstrated ability to solve difficult technical problems and deliver practical solutions that meet the application requirements is required. This includes strong analytical, problem-solving, and decision-making skills with the ability to be observant and to think creatively
Demonstrated ability to design experiments and analyze data with appropriate quality and statistical methodologies
Demonstrated ability to work independently as well as effectively be a strong team contributor and work cross-functionally to expedite the completion of critical project tasks
Ability to handle multiple project assignments of medium scope and complexity and able to prioritize and complete work with a sense of urgency in a timely manner
Ability to lead directly and by influence, including strong problem-solving, conflict resolution, and analytical skills
Requires strong leadership skills, excellent written and verbal communication and presentation skills
Working knowledge of FDA requirements as per 21 CFR 820, ISO 9001, ISO 13485:2003, and ISO 14971:2007
Working knowledge of Good Documentation Practices (GDP), and Good Manufacturing Practices (cGMP)
Good understanding of statistical tools and validation/verification techniques
Proficiency in the use of Microsoft Excel, Microsoft Word, and Microsoft PowerPoint is required
Legal authorization to work in the United States is required
Preferred
An advanced degree (MS or Ph.D.) is strongly preferred
Hands-on experience in product development with Class II and Class III medical devices
Experience developing test methods and protocols/reports for safety and efficacy testing of implant and instrument designs
Experience with IDE and PMA submissions
Six-Sigma green belt or black belt certification
Benefits
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, FSA: Dependent & Healthcare, Commuter & Parking Benefits, Long Term Disability Coverage
Company
Cresilon
Cresilon is a medical device company that produces and markets solutions for trauma care.
51-200 employees
H1B Sponsorship
Cresilon has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2021 (2)
Funding
Current Stage
Growth StageTotal Funding
$100.66MKey Investors
Paulson Investment Company
2025-09-09Series Unknown· $23.86M
2022-10-27Series A· $25M
2021-04-08Series A· $14M
Leadership Team
Isaac Miller
EVP, Co-Founder
Scott Levine
Chief Financial Officer
Recent News
Crain's New York Business
2025-09-10
2025-09-06
Company data provided by crunchbase