Research And Development Medical Device Engineer

Cresilon, Inc is a medical device company based out of Brooklyn, NY that focuses on bringing new technologies to the animal health industry that aim to solve problems associated with wound healing. We have created a hemostatic device that can instantly stop traumatic bleeding. Please refer to these associated links to learn more about Cresilon:
https://www.bloomberg.com/news/videos/2014-11-19/bandaid-of-the-future-stops-bleeding-instantly
http://www.ted.com/talks/joe_landolina_this_gel_can_make_you_stop_bleeding_instantly?language=en
The Medical Device Engineer is responsible for leading design and development activities of new products and improving existing products with compliance to all quality and regulatory requirements. S/he 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 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 proto-type design and fabrication and data generation through designed experiments.
The Medical Device Engineer is expected to aspire for excellence with a bias towards action, willing to roll up sleeves, get hands on and do what’s necessary to move projects forward in a fast-paced environment. S/he is 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 in 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.
This is a full-time, on-site position, located in Brooklyn, New York. Level will be contingent on educational and prior industrial experiences.
Responsibilities

• Create and lead experimentation for exploratory and/or product development research with focus on polymeric materials devices and their use.
• Communicate results to the scientific community via published papers. Present research at academic/industry symposia as an external representative of the company.
• Work cooperatively with, quality, manufacturing, regulatory, clinical, and marketing to ensure project success.
• Provide other project or product support as needed in order to support Cresilon’s business objective.
• Manage part-time staff as a research leader and mentor for ongoing research projects.
• Prepare samples as required for testing, or other evaluations and data analysis, including in voice-of-customer (VOC) labs.
• Lead the creation of design history file documentation through the new product development process.
• Exercise technical judgment in the design, execution and interpretation of experiments within the scope of project responsibilities and ensure the use professional concepts to solve complex problems in creative and effective ways, in conformance with scientific methods and procedures.
• Generate technical protocols/reports to support device safety and efficacy.
• Responsibilities may include other duties as assigned and as requiread
• Develop and execute of 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.
• Maintain a laboratory notebook and other technical documentation according to required GLP/GMP guidelines.
• Author protocols and reports including development studies and design verification/validation activities.
• Maintain active dialogue with Regulatory Affairs as subject matter expert on all product design elements/documentation pertaining to research towards FDA/regulated authority submissions,
• Ensuring 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 design control process, with well-documented research/analyses.
• Work with company leadership to evaluate existing research practices and contribute to a culture of ethical, high-quality research operations within the organization.
• 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.
• Define new product functional requirements (design inputs/user needs) and evaluate the design's overall effectiveness, cost, reliability, and safety.
• Provide support to marketing and sales team, support introduction of new technologies with development of presentations, sales tools, formulations and applications data
• Work independently to plan and schedule own activities necessary to meet project timelines.
• Develop new implant and instrument designs utilizing Solidworks and modeling/detail design specifications.
• Interface with customers, suppliers, and internal cross-functional team members to develop specifications and coordinate prototype fabrication.
• Invent/create concepts and designs and submit invention disclosures.

Requirements

• Ability to lead directly and by influence, including strong problem solving, conflict resolution, and analytical skills is required.
• 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 is required.
• Legal authorization to work in the United States is required.
• Experience gathering user needs, translating them to technical inputs, developing viable V&V (Design Verification and Validation) plans required.
• Proficient in the use of Microsoft Excel, Microsoft Word, Microsoft PowerPoint is required.
• Experience leading complex product development initiatives from concept through release, preferred.
• Adept experimentalist with hands-on experience in product development of polymeric medical devices and their safety/efficacy characterization in a R&D environment is strongly preferred.
• Working knowledge of Good Documentation Practices (GDP), and Good Manufacturing Practices (cGMP) preferred.
• Requires strong leadership skills, excellent written and verbal communication and presentation skills.
• 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 required.
• BS in Chemical Engineering, Polymer Engineering, Material Science, Biomedical Engineering, Mechanical Engineering, or related scientific discipline with 4+ years of product development experience is required. An advanced degree (MS or Ph.D) is highly preferred.
• Good understanding statistical tools and validation/verification techniques, preferred.
• Good working knowledge of anatomy and surgical procedures, preferred.
• Experience developing test methods and protocols/reports for safety and efficacy testing of implant and instrument designs is strongly preferred.
• Demonstrated ability to work independently as well as effectively be a strong team contributor and work cross functionally to expedite completion of critical project tasks is required.
• Working knowledge of FDA requirements as per 21 CFR 820 and ISO 9001, ISO 13485:2003 and ISO 14971:2007 is strongly preferred.
• Demonstrated ability to design experiments and analyze data with the use of appropriate quality and statistical methodologies is required. Six sigma green belt or black belt certification preferred.
• Minimum of 2 years hands-on experience in new product research and development in a cGMP regulated industry is required (work experience in the Medical Device field strongly preferred)

Benefits

• 401(k) Retirement Savings Plan with company match
• Paid Vacation and Holidays
• Medical, Dental, and Vision Insurance
• Competitive annual base salary range of $60,000 - $160,000, depending upon job level and qualifications
• Company Paid Life and Short-Term Disability Coverage