Position
Product Development Engineer (2-4 Yrs of required exp in Medical Devices)
Location
Irvine, CA
Duration
12 Months
Total Hours/week
40.00
Shift
1st Shift
Client
Medical Devices Company
Job Category
Engineering
Level of Experience
Mid-Level
Employment Type
Contract on W2 (Need US Citizens or GC Holders or GC EAD or OPT or EAD or CPT)
Onsite
4 days
Job Description
Provide solid technical skill and engineering support for design and development activities for new and existing products.
Support current products in terms of quality, manufacturing, supply continuity and cost improvement.
Participate in executing technical and/or cross-functional project work. Contribute to a culture of innovation by proactively generating novel concepts for new products and enhancements to current product performance. Understand customer needs through literature review, customer interviews, direct observation, competitive analysis, prototype evaluation, and clinical/simulated use studies.
Translate customer needs into engineering requirements into specific product, packaging and process specifications.
Engineer robust and manufactuarable products through strong understanding and application of engineering fundamentals.
Develop and execute test methods which specify measurement equipment, test set-up, measurement systems analysis, and data analysis. Write detailed technical reports based on design verification analysis/testing for design changes and product design activities.
Ensure compliance with client quality policies, procedures and practices as well as with all local, state, federal and client safety regulations, policies and procedures.
BS degree in engineering is required (Mechanical or Biomedical Engineering preferred).
2-4 years of engineering experience is required in medical devices.
Test, and/or improve products by developing moderately complex experiments and tests (including writing and executing protocols), analyze results, make recommendations, and develop reports, based on engineering principles
Generate work instructions, test methods, engineering drawings/prototypes, etc. to establish/characterize product and/or process specifications
Create/update portions of design control documents including requirement specs and risk documents
Assign R&D support tasks; gives instruction to technicians on conducting tests; train technicians and provide feedback; and coordinate technician work
Identify, evaluate, manage, and provide guidance to suppliers, including establishing tolerances and defining acceptance criteria for suppliers
Good computer skills in usage of MS Office Suite; CAD experience preferred
Good documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills
Basic understanding of statistical techniques
Previous experience working with lab/industrial equipment required (if applicable)
Solid understanding and knowledge of principles, theories, and concepts relevant to Engineering
Solid problem-solving, organizational, analytical and critical thinking skills
Solid understanding of processes and equipment used in assigned work
Strict attention to detail
Ability to interact professionally with all organizational levels
Ability to manage competing priorities in a fast paced environment
Must be able to work in a team environment, including the ability to manage vendors and project stakeholders
Ability to build productive internal/external working relationships
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