Job Description

The Staff Mechanical Engineer shall produce specifications for, design, develop, verify and validate new or modified mechanical components or systems in medical-grade sterilization capital, accessories and consumables. Duties and Responsibilities Under limited supervision, general direction, etc. and in accordance with all applicable government laws, regulations and ASP policies, procedures and guidelines, this position: Deliver and drive results by participating in new product development projects either as a team member or work stream leader focused on mechanical centric design and development Connects by demonstrating strong collaboration with cross functional team members to ensure alignment and influencing of design concepts, design inputs, design outputs, and design verification. Provides strong technical leadership on assigned projects to deliver design concepts, design characterization, design inputs, design outputs, and design verification using sound engineering principles and expertise. Provides guidance and mentorship to junior engineers, draftsmen, technicians and contractors. Responsible for communicating business related issues or opportunities to next management level Performs other duties assigned as needed Other Duties: Assess project requirements Measure the performance of mechanical components, devices and systems Align budgets, timescales and specifications with cross-functional stakeholders, customers and management Use computer-aided design, FEA and CFD software Undertake relevant research Produce and Implement designs and test procedures with compliant GDP Present designs, drive technical reviews and own work streams Write protocols, reports and other QMS documentation Providing technical support to cross-functional teams Analyze and interpret data. Qualifications Education: Bachelor s Degree, Mechanical Engineering Years of Related Experience : List specific types of experience and years that may be required for this position, such as: 8+ year of related experience in new product development required; highly regulated industry experience preferred (e.g. Aerospace, Automotive, Medical Devices) 6+ years minimum of CAD design experience required; SolidWorks preferred Knowledge, Skills, Abilities, Certifications/Licenses, and Affiliations : (Include any required computer skills, regulatory knowledge, certifications, licenses, languages, cognitive and behavioral abilities etc.) Thorough understanding of Design Verification and Validation highly preferred Strong written and verbal communication required Design experience for plastics highly preferred GD&T working knowledge highly preferred Medical device product development experience highly preferred Fluidic Systems experience a plus Sterilization and/or disinfection experience a plus Responsibility For Others and Internal Interactions N/A This position does not entail direct supervisory responsibilities. Internal interface activities will include but not limited to, Quality, Operations, Regulatory Compliance, Marketing, Medical Safety, Field Services and Medical Safety. External Interactions N/A Liaise with suppliers, development partners and manufacturers to support new product development, sustaining engineering and manufacturing.