Senior Engineer - NPD/R&D – Vascular Closure

We are constantly looking to add to our core talent. If you are seeking a career that is challenging and rewarding, a work environment that is diverse and dynamic, look no further — Haemonetics is your employer of choice. Job Details Summary: This engineering position requires strong technical and time management skills to support the design and development of innovative, new products within the Vascular Closure Group. The Senior Engineer will apply advanced technical principles, theories, and concepts related to new product introduction and research and development projects. This individual will work closely with cross functional teams to ensure products are launched on time and in compliance with internal SOP, FDA and international regulations. Essential Duties and Responsibilities: Work closely with cross-functional team such as Manufacturing, Regulatory and Quality, to take a product from concept to commercialization. Utilize advanced experimental design methodologies, with significant complexity, and execute test protocols and reports to facilitate the design of medical devices. Develop clinical relevant bench top test models and methods for device performance evaluation. May be involved in product preclinical testing to investigate product performance. Analyze data using advanced statistical techniques and communicate results to a cross-functional team. Responsible for managing design control activities to ensure deliverables are done in compliance with internal SOPs, FDA and international regulatory regulations. Qualifications: Experience with product concept development, customer interaction, and validation of customer needs/design requirements. Working knowledge of CAD (Solidworks) is preferred. Understanding and experience in design, development, and testing of cardiovascular catheter delivery systems, or equivalent devices is a plus. Familiarity with good manufacturing processes (GMP), QMS, and domestic and international regulatory agencies requirements. Strong knowledge of design control and quality system requirements. Experience with high volume production environment is preferred. Experience with IDE, PMA and Class III device classification is preferred. Education and Experience: Bachelor’s degree in technical concentration (Mechanical or Manufacturing Engineering, Bioengineering, Industrial Engineering, etc.) is preferred. Minimum of 5 years of experience in the medical device industry. Skills: Excellent written and verbal communication skills. Independent thinker with team oriented mindset. Ability to identify critical path and mitigate risk as early as possible. Possess good mechanical aptitude to assist in design and problem resolution. Physical Demands: Ability to travel up to 20%. EEO Policy Statement Conditions of Employment: Haemonetics’ policy requires COVID-19 vaccination for all U.S. employees, unless approved for a medical, religious or business exemption. While we recognize employees have their own individual beliefs and perspectives regarding vaccination, we believe it is an important step as part of our obligation to protect our colleagues, our customers and our communities as we continue to make health and safety our top priority.