Mechanical Engineer 4

Title: Mechanical Engineer 4

Location: On- Site Santa Clara office

Job Description 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 Principal 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. This Product Development Engineer will be responsible for acting as the lead design engineer on Disposables R&D projects.




Essential Duties and Responsibilities:
o Lead R&D efforts relating to product sustaining and life-cycle management for Haemonetics Disposable products, including CAPAs, SCNs, and Design-related initiatives and programs.
o Hands-on device testing, troubleshooting, prototype development as well as lab equipment maintenance.
o Provide technical and project leadership directing initiatives of varying size, scope, and complexity with effective management of project Scope, Time, Budget, and Communication.
o Work closely with cross-functional teams such as Manufacturing, Regulatory and Quality, to take a product from concept to commercialization.
o Utilize advanced experimental design methodologies, with significant complexity, and execute test protocols and reports to facilitate the design of medical devices.
o Develop clinically relevant bench top test models and methods for device performance evaluation.
o May be involved in product preclinical testing to investigate product performance.
o Analyze data using advanced statistical techniques and communicate results to a cross-functional team.
o Responsible for managing design control activities to ensure deliverables are made in compliance with internal SOPs, FDA and international regulatory regulations.
Qualifications:
o Experience with IQ/OQ of lab equipment and maintenance of PM and Calibration.
o Experience in device testing, troubleshooting, and prototype development.
o Experience with product concept development, customer interaction, and validation of customer needs/design requirements.
o Working knowledge of Medical Device Design Control including active management of Design History File elements and quality system requirements.
o Advanced Working knowledge of CAD (Solidworks) and fixture design.
o Working knowledge of statistical study designs (DOE, ANOVA, etc.) for feasibility and design verification of disposables.
o Understanding and experience in design, development, and testing of cardiovascular catheter delivery systems, or equivalent devices is a plus.
o Familiarity with good manufacturing processes (GMP), QMS, and domestic and international regulatory agencies requirements.
o Experience with high volume production environment is preferred.
o Experience with IDE, PMA and Class III device classification is preferred.
o Familiarity with AGILE is a plus.




Education and Experience:
o Bachelor's degree in technical concentration (Mechanical or Manufacturing Engineering, Bioengineering, Industrial Engineering, etc.) is preferred.
o Minimum of 7 years of experience in the medical device industry.
Skills:
o Displays solid written and verbal communication and presentation skills, and effectively communicates with customers, multiple teams and diverse stakeholders across the company.
o Independent thinker with team-oriented mindset.
o Ability to identify critical path and mitigate risk as early as possible.
o Possess good mechanical aptitude to assist in design and problem resolution.
Physical Demands:
Ability to travel up to 20%.