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Position: Sr R&D Engineer for a Medical Devices Company. Duration: 12+ Months Contract. Total Hours/week: 40.00.
Job Responsibility:
Drive design and development of product systems, subsystem and components by understanding design space with design options and tradeoffs, managing critical parameters, using design for manufacture principles as well as geometric dimensioning and tolerancing tools
Integrate product systems and subsystems to meet business objectives by addressing customer needs and product requirements under defined cost targets
Identify the best tools and approaches to effectively solve engineering problems to develop/optimize designs by leveraging appropriate mix of first principles / analytical, computational and experimental methods
Ensure implementation and rigor of product development processes and design control procedures
Support current products in terms of quality, manufacturing, supply continuity and cost improvement
Support execution of technical and/or cross-functional project work
Analyze design solutions using engineering first principles and advanced engineering methods such as FEA
Write detailed technical reports based on design verification analysis/testing for design changes and product design activities
Develop and execute test methods which specify measurement equipment, test set-up, measurement systems analysis, and data analysis
Develop realistic and actionable design plans
Demonstrate strong accountability for successful completion of designated tasks
Develop deliverables schedules and demonstrate accountability for successful completion of tasks/projects and team deliverables
Effectively collaborate with laboratory technicians and support staff
Requirements:
BS or MS degree in Engineering (Mechanical Engineering, Materials Science & Engineering, Biomedical Engineering or a closely related engineering degree required)
Minimum of 3 years of engineering experience or equivalent is required with a strong preference for least 2 year product development and design experience in medical devices / products
Medical device design and development experience related to high-volume manufacturing is strongly preferred
Experience with contact and non-contact metrology
Experience with manufacturing process validation including strategy development, First Article Inspection, Factory Acceptance Testing, and IQ/OQ/PQ’s
Knowledge of disciplined product development processes, regulatory and quality requirements such as 21CFR820.30
Strong design control experience
Developed understanding of DOE and statistical methods
Understanding of failure theory and modes for plastics, elastomers, and metals due to static and time-variable loading conditions
Nice to have:
Prefer Masters Degree
Prefer local and onsite meetings
Looking for some stability in work history, no gaps or jumping around, unless explained for review
Solidworks, Minitab, and FEA (Abaqus / Fluent) experience is preferred