Cresilon · 3 weeks ago
Research and Development Engineer I/II
Brooklyn, NY
Full-time
Onsite
Entry, Mid Level
$70K/yr - $120K/yr
4+ years expCresilon is a Brooklyn-based biotechnology company that develops, manufactures, and markets hemostatic medical devices utilizing proprietary hydrogel technology. The R&D Engineer I/II will support product design and process development activities while ensuring compliance with quality and regulatory requirements, collaborating with a multidisciplinary team to innovate and enhance product processes.
BiotechnologyHealth CareMedicalMedical Device
Responsibilities
Oversee the planning, implementation, and analysis of experiments relevant to project objectives. Ensure the application of established scientific and engineering principles to solve complex problems and challenges innovatively and efficiently, adhering to rigorous scientific methodologies and protocols
Create and execute product/process enhancement, and new product/process development plans
Lead material/design/process changes and their implementation with well-documented research/analyses. Process and analyze results
Author protocols and reports including engineering studies and design verification/validation activities
Aid in the development and execution of testing methods to aid in exploratory research, product/process development, and quality control; conduct chemical and mechanical property evaluation tests to assess the desirability of process or formulation changes
Prepare samples as required for manufacturing, testing, or other evaluations and data analysis
Participate in voice-of-customer (VOC) labs and other user needs assessments
Interface with external vendors, customers, and suppliers. Specify equipment and process requirements for developing and implementing new products, product improvement and new equipment/processes
Support process and product transfers to manufacturing or CDMOs
Maintain a laboratory notebook and other technical documentation according to required GLP/GMP guidelines
Understand and prioritize process improvements, design experiments to make those improvements, and execute these plans in the laboratory
Maintain active dialogue with Regulatory Affairs as subject matter expert on all product design elements/documentation about research towards FDA/regulated authority submissions
Provide support to the marketing and sales team, with the development of presentations, sales tools, and application data
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 to support Cresilon's business objectives
Qualification
Required
Education: BS in Chemical Engineering, Polymer Engineering, Material Science & Engineering, or related engineering discipline
Minimum 4+ years previous experience in an industrial environment with a BS degree. (2 years minimum experience if advanced degrees)
Proficiency as an adept experimentalist with hands-on experience in the product and process development of polymeric materials and their characterization in an R&D or manufacturing environment
Mathematically inclined with strong analytical and problem-solving skills with the ability to be observant and to think creatively. Demonstrated ability to design experiments and analyze data with the use of appropriate quality and statistical methodologies. Demonstrated ability to work independently as well as be a strong team contributor. Ability to effectively work within a team and cross-functionally to expedite the completion of critical project tasks
Requires understanding of product/process design and engineering. Experience should include process development/validation and/or transfer/verification, protocols, and troubleshooting skills
Ability to handle multiple project assignments of medium scope and complexity and able to prioritize and complete work with a sense of urgency on time
Ability to lead directly and by influence, including strong problem-solving, conflict resolution, and analytical skills
Working knowledge of Good Documentation Practices (GDP) and Good Manufacturing Practices (cGMP) requirements
Proficiency in the use of Microsoft Office, Microsoft Excel, Microsoft Word, Microsoft PowerPoint is required
Requires excellent written and verbal communication and presentation skills
Legal authorization to work in the United States is required
Physical Requirements include: Aseptic Gowning Qualification: Able to be successfully qualified for aseptic gowning, including successful respirator training
Wear Appropriate Personal Protective Equipment (PPE):
Be able to stand and walk for prolonged periods, with the ability to climb, balance, stoop, bend, reach, and handle equipment
Ability to speak, listen, and understand verbal and written communication
Possesses hand-eye coordination and manual dexterity for delicate manipulations
Ability to lift up to 50 pounds occasionally and to carry, push, pull, or otherwise move objects
Visual acuity is required for performing close and distant activities
Preferred
An advanced technical degree (MS or PhD)
Lab experience in an industry setting within cGMP-regulated environments
Prior experience developing processes and scaling these up into manufacturing or CDMO
Mechanical/electrical knowledge with the ability to troubleshoot processing equipment
Six Sigma green belt or black belt certification preferred
Experience implementing process and quality improvements in a manufacturing environment
Work experience with the medical device or pharmaceutical industries
Working knowledge of ISO 9001, ISO 13485:2003 and ISO 14971:200
Working knowledge of FDA requirements as per 21 CFR 820
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