MillenniumSoft Inc ยท 2 days ago
Product Development Engineer (2-4 Yrs of required exp in Medical Devices) Onsite
Irvine, CA
Full-time
Onsite
Entry, Mid Level
2+ years expMillenniumSoft Inc is a company seeking a Product Development Engineer to provide technical support for the design and development of medical devices. The role involves collaborating on product quality, executing project work, and translating customer needs into engineering requirements.
Staffing & Recruiting
No H1B
Responsibilities
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 manufactural 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
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
Qualification
Required
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 manufactural 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
Preferred
Mechanical or Biomedical Engineering preferred
CAD experience preferred
Company
MillenniumSoft Inc
Hire us to hire for you Staffing is not a straightforward activity.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Sailaja Mashetty
Partner - Customer Sucess
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