R&D Engineer

United Pharma; California; On-site; USD 130,000 - 170,000; Full time

Job summary

United Pharma in California seeks an experienced Product Engineer to lead end-to-end development, from design through validation, ensuring regulatory compliance and high-quality outcomes.

You will drive technical decisions, develop engineering specifications, and mentor junior engineers while collaborating with R&D, Quality, Manufacturing, Marketing, and Regulatory teams to align with project goals and timelines.

Qualifications

• Bachelor's degree in Mechanical, Electrical or Biomedical Engineering or related discipline.
• 5–8+ years of product engineering/product development experience.
• Experience in medical device or other regulated environments is preferred.
• Experience with Design Controls is preferred.

Responsibilities

• Lead end-to-end product development activities including design, prototyping, testing, verification, and validation.
• Drive technical decisions and engineering expertise throughout the product lifecycle.
• Develop and review engineering specifications, design documents, and technical reports.
• Apply systematic problem-solving approaches to resolve complex engineering challenges.
• Support design analysis and engineering evaluations during product development.
• Contribute to lifecycle management from development through commercialization.
• Collaborate with R&D, Quality, Manufacturing, Marketing, and Regulatory teams.
• Mentor junior engineers and communicate complex concepts to stakeholders.
• Participate in design reviews, FMEA, risk assessments, and change-control processes.
• Stay current with industry trends and regulatory requirements.

Skills

End-to-end product development

Technical decisions

Engineering documentation

Problem solving

Design analysis

Product lifecycle management

Education

Bachelor's degree in Mechanical Engineering

Bachelor's degree in Electrical Engineering

Bachelor's degree in Biomedical Engineering

Related Engineering discipline

Job description

• Lead end-to-end product development activities, including design, prototyping, testing, verification, and validation.
• Drive technical decisions and provide engineering expertise throughout the product lifecycle.
• Develop and review engineering specifications, design documents, and technical reports.
• Apply systematic problem-solving approaches to identify and resolve complex engineering challenges.
• Support design analysis and engineering evaluations throughout product development.
• Contribute to product lifecycle management activities from development through commercialization.

Cross-Functional Collaboration

• Partner with R&D, Quality, Manufacturing, Marketing, and Regulatory teams to ensure alignment throughout product development.
• Serve as a technical resource and mentor for junior engineers.
• Communicate complex technical concepts clearly to both technical and non-technical stakeholders.
• Participate in cross-functional design and technical reviews.
• Lead or contribute to multiple concurrent engineering and product development projects.
• Define project scope, timelines, milestones, and deliverables.
• Track project progress and proactively manage risks, dependencies, and technical challenges.
• Collaborate with cross-functional stakeholders to ensure projects remain aligned with established objectives and timelines.

Quality & Regulatory Compliance

• Ensure products meet applicable regulatory requirements, industry standards, and internal quality requirements.
• Support Design Verification and Design Validation (V&V) activities.
• Participate in formal design reviews, FMEAs, risk assessments, and change-control processes.
• Apply design-control principles throughout the product development lifecycle.
• Support compliance with applicable medical-device regulatory frameworks, including FDA 21 CFR Part 820 and ISO 13485, where applicable.
• Identify opportunities to improve products, processes, and engineering practices.
• Apply data-driven analysis to evaluate product and process performance and support engineering decisions.
• Utilize systematic problem-solving methodologies to address technical and product issues.
• Stay current with industry trends, emerging technologies, engineering practices, and applicable regulatory requirements.

Required Qualifications

Education

• Bachelor's degree (B.S.) in:
• Mechanical Engineering
• Electrical Engineering
• Biomedical Engineering
• or a related Engineering discipline.

Experience

• 5–8+ years of product engineering/product development experience.
• Experience with product development across design, testing, verification, and validation.
• Experience working in medical device or other regulated industry environments is preferred.
• Experience with Design Controls is preferred.