Engr , Product Development - Onsite; Exp in Medical Devices

Engr 2, Product Development – Onsite (Required Exp in Medical Devices)

Location: Irvine, CA
Duration: 12 Months
Hours per Week: 40
Shift: 1st Shift
Client: Medical Devices Company
Job Category: Engineering
Level of

Experience:

Mid-Level
Employment Type: Contract on W2 (US citizens or GC holders or GC EAD or OPT or EAD or CPT)

Onsite 4 days

Position:
Product Development Engineer (2‑4 years of required experience in Medical Devices)

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, contributing 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 and specific product, packaging, and process specifications.
• Engineer robust and manufacturable 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 required (Mechanical or Biomedical Engineering preferred).
• 2‑4 years of engineering experience required in medical devices.
• Test and/or improve products by developing moderately complex experiments and tests (including writing and executing protocols), analyzing results, making recommendations, and developing 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; provide 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 (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.