Job Title: R&D Engineer IV (Senior R&D Engineer)
Location: Valencia, CA (Hybrid – 3 days onsite: Tues/Wed/Thurs; flexibility required Mon/Fri if needed)
Contract Duration: 6 months
Pay: $82 an hour or about $166,000 a year
Work Authorization:Applicants must be authorized to work in the U.S. without current or future visa sponsorship.
Position Overview
The hiring manager is seeking a Senior R&D Engineer to support design control activities, including test method development and validation, fixture and tooling design using SolidWorks, product drawing updates, and creation of traceable documentation (e.g., specification maps, DFMEAs).
Key Responsibilities
- Provide engineering support for design control activities
- Develop and validate test methods, including protocol and report generation
- Design and develop fixtures and tooling using SolidWorks
- Update and maintain product drawings using SolidWorks
- Create and maintain traceable documentation (e.g., specification maps, DFMEAs, risk documentation)
- Ensure compliance with all Design Control requirements, including:
- Requirement development and sourcing
- Risk documentation
- Verification and validation testing
- Support manufacturing transfers between vendors
- Maintain product safety, quality, and regulatory compliance
- Participate in and support change management processes (DCA, SCIA, SCAR, PLCP)
- Collaborate cross-functionally with R&D, Quality, Manufacturing, and external suppliers
- Manage multiple projects simultaneously using strong project management and problem-solving skills
- Compile, analyze, and report test, operational, and research data
- Support planning and execution of R&D projects
- Ensure compliance with FDA Quality System Regulations and ISO 13485
- Perform additional duties as required by the business
Required Qualifications
- 5+ years of experience with design controls
- 5+ years working within FDA QSR and ISO 13485 environments
- Experience with design verification and validation (V&V)
- Experience in test method development and validation
- Experience assessing quality and compliance impacts of design/process changes
- Strong experience in troubleshooting and root cause analysis
- Proficiency with SolidWorks and working knowledge of Minitab
- Strong technical writing and communication skills (protocols, reports, assessments)
- Ability to work independently with minimal supervision
Preferred Qualifications
- Experience leading 4+ projects involving product or process changes
- 3+ years of mechanical design experience
- Participation in 4+ new product development (NPD) projects, including transfer and scale-up
- Experience with SAP and Windchill
- Experience with Human Factors / Usability engineering
Education & Experience
- Bachelor’s degree with 5–8 years of experience
- Master’s degree with 3–6 years of experience
- PhD with 0–3 years of experience
Quality Systems Responsibility
Ensure quality is built into all aspects of work by maintaining compliance with all applicable quality system requirements.