Cresilon® is a Brooklyn-based biotechnology company that develops, manufactures, and markets hemostatic medical devices utilizing the company’s proprietary hydrogel technology. The company’s plant-based technology has revolutionized the current standard by stopping traumatic and surgical bleeds in seconds without the need for extended manual pressure. The company's current and future product lines target veterinary, human trauma, and human surgical applications. Cresilon's mission is to save lives. Learn more about the company at www.cresilon.com.
Description:
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. They will be responsible for authoring technical documents for the development of medical devices and combination products according to relevant Design Control regulations and standards. The person in this position will also be responsible for providing project-specific support, including technical analysis and review of supplier documentation as required. The position has a scientific focus that includes formulation development, product performance characterization, and implementation, including prototype design and fabrication, and data generation through designed experiments.
The Senior Medical Device Engineer is expected to aspire for excellence with a bias toward action, willing to roll up their sleeves, get hands-on, and do what’s necessary to move projects forward in a fast-paced environment. They are committed to designing and developing products that dominate the marketplace and improve healthcare by partnering with our customers to drive purposeful innovation, resulting in best-in-class products. The Medical Device Engineer will work with a multidisciplinary team of researchers. This is a multi-faceted job in a highly collaborative environment across multiple functions that will require flexibility as well as an ability to learn about and develop new technologies and explore new techniques in pursuit of product innovation and robustness.
Role level is contingent on experience, but this is not an entry level role.. This is a full-time, on-site position, located in Brooklyn, New York.
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.
Required Qualifications
- 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 Qualifications
- 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
Cresilon is an equal-opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. Cresilon makes hiring decisions based solely on qualifications, merit, and business needs at the time.
- Competitive annual base salary range of $100,000 - $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, FSA: Dependent & Healthcare, Commuter & Parking Benefits, Long Term Disability Coverage