Senior Design Assurance Engineer - Hardware
Responsibilities of the Sr Design Assurance Engineer-Hardware:
Perform Design Assurance engineering work requiring full competency in all conventional aspects of mechanical or electrical engineering.
Plans and conducts design assurance activities requiring judgment in the independent evaluation, selection and the substantial adaptation of standard mechanical/electrical engineering techniques, testing procedures and criteria; works closely with product development engineering to establish new approaches to problems as encountered.
Actively participates in design development ensuring design verification tests and validation activities related to new product development conform to established product requirements and sound testing principles. Supports and closely works with Suppler Quality to develop and accept vendor Supplier Quality Plans for new and existing components. Plans and coordinates detailed phases of Design Assurance for part of a major project or a total project of moderate scope. Conducts Design Assurance engineering activities of significant scope or degree of difficulty (medium-large component/system/process associated with a medium to large project).
• Writes test specifications and test methods.
• Monitors new projects and interacts with other engineers to determine design criteria.
Generate documentation associated with verification/validation of equipment, products, and components.
Qualifications of the Sr Design Assurance Engineer- Hardware:
Bachelor's degree in Mechanical/Electrical Engineering or related engineering field, with seven to ten years’ professional level experience within the medical, or a closely related industry is required. Specific experience in design assurance desirable.
• Masters degree in engineering, with four to six years’ medical
• Ph.D. in engineering, with three to five years’ medical
• In depth knowledge of ISO 13485, ISO 14971, 21 CFR 820 Design Controls.
•Depth of knowledge of applicable QSSOPs, regulations, and standards etc. with proven skill in integrating into mechanical engineering discipline.
• Knowledge and skill in mechanical engineering documentation procedures, development methods and project management, with the ability to rapidly master Smiths Medical internal procedure and methods, such as Documentation System, ECOs, DOEs, DVTs, MDAs, etc.
• Controls/constraints over this position include policies and procedures for hardware development and GMP requirements.