Research and Development Medical Device Engineer
Research and Development Medical Device Engineer
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$ 80000 - 160000
1 Vacancy
Job Description
Cresilon is a Brooklynbased biotechnology company that develops manufactures and markets hemostatic medical devices utilizing the companys proprietary hydrogel technology. The companys plantbased technology has revolutionized the current standard by stopping traumatic and surgical bleeds in seconds without the need for extended manual pressure. The companys current and future product lines target veterinary human trauma and human surgical applications. Cresilons mission is to save lives. Learn more about the company at .
The 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. 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 person in this position will also be responsible for providing projectspecific 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 Medical Device Engineer is expected to aspire for excellence with a bias toward action willing to roll up their sleeves get handson and do whats necessary to move projects forward in a fastpaced 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 bestinclass products. The Medical Device Engineer will work with a multidisciplinary team of researchers. This is a multifaceted 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. This is a fulltime onsite 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 designs overall effectiveness cost reliability and safety.
- Lead crossfunctional teams to develop new products address design issues and maintain existing designs.
- Apply strong problemsolving 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 welldocumented 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 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 voiceofcustomer (VOC) labs.
- Interface with customers suppliers and internal crossfunctional 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 parttime 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 highquality research operations within the organization.
- Provide other project or product support as needed in order to support Cresilons business objective.
- Responsibilities may include other duties as assigned and as required.
Requirements
Required Qualifications
- BS in Chemical Engineering Polymer Engineering Material Science Biomedical Engineering Mechanical Engineering or related scientific discipline.
- A minimum of 4 years of product development experience is required.
- A minimum of 2 years of handson experience in new product research and development in a cGMPregulated industry is required (work experience in the Medical Device field is strongly preferred)
- Adept experimentalist with handson 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 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 problemsolving and decisionmaking 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 crossfunctionally to expedite 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 problemsolving conflict resolution and analytical skills.
- Requires strong leadership skills and excellent written and verbal communication and presentation skills.
- Working knowledge of FDA requirements as per 21 CFR 820
- Proficient in the use of Microsoft Excel Microsoft Word Microsoft PowerPoint is required.
- Legal authorization to work in the United States is required.
Preferred Qualifications
- An advanced degree (MS or Ph.D. is highly preferred.
- Handson experience in product development with polymeric materials.
- Experience 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 in IDE and PMA submissions.
- Working knowledge of Good Documentation Practices (GDP) and Good Manufacturing Practices (cGMP)
- Good understanding of statistical tools and validation/verification techniques.
- SixSigma green belt or black belt certification
Cresilon is an equalopportunity 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.
Benefits
- Competitive annual base salary range of $80000 $160000 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 ShortTerm Disability Coverage
- Medical Dental and Vision Insurance FSA: Dependent & Healthcare Commuter & Parking Benefits Long Term Disability Coverage
Employment Type
Full-Time
