Product Development Engineer I — Medical Devices (Irvine)

Lancesoft INC; California (MO); On-site; USD 70,000 - 90,000; Full time

Job summary

LanceSoft is seeking a Product Development Engineer I in Irvine, CA. The role focuses on design and development support for new and existing products, ensuring quality, cost improvements, and manufacturing continuity.

You will work with cross-functional teams to translate customer needs into engineering specifications and develop robust test methods. Candidates should have a BS in Engineering and 0–3 years of experience, with familiarity in CAD tools and statistical analysis.

Qualifications

• Must have demonstrated ability to manage multiple projects with scope, schedule, budget and stakeholders
• Must be able to use Mechanical CAD tools (SolidWorks, CREO, ProE)
• Ability to work independently with multi-level teams in a fast-paced, changing environment
• Develop root cause analysis techniques
• Familiar with ISO, FDA, OSHA, ASTM standards/regulations
• Operate and troubleshoot mechanical test equipment in the lab
• Develop operation of environmental conditioning chambers, equipment calibration and maintenance

Responsibilities

• Provide technical engineering support for design and development of new and existing products
• Support current products in terms of quality, manufacturing, supply continuity and cost improvement
• Participate in executing technical and cross-functional project work
• Contribute to innovation by generating novel concepts for new products and enhancements
• Understand customer needs via literature review, interviews, observations, competitive analysis, prototypes, and studies
• Translate customer needs into engineering requirements and specifications
• Engineer robust and manufacturable products
• Develop and execute test methods with measurement equipment, setup, MSA and data analysis
• Write detailed technical reports based on design verification testing
• Ensure compliance with quality policies and safety regulations

Skills

Project management

CAD tools

Independent work

Root cause analysis

Regulatory knowledge

Lab testing

Environmental conditioning

Engineering fundamentals

Statistical tools

Education

BS in Engineering (Mechanical or Biomedical)

Tools

SolidWorks

CREO

ProE

Job description

LanceSoft is seeking a Product Development Engineer I in Irvine, CA. The role focuses on design and development support for new and existing products, ensuring quality, cost improvements, and manufacturing continuity.

You will work with cross-functional teams to translate customer needs into engineering specifications and develop robust test methods. Candidates should have a BS in Engineering and 0–3 years of experience, with familiarity in CAD tools and statistical analysis.