Sr Product Engineer

Planet Pharma; Los Angeles (CA); On-site; USD 69,000 - 73,000; Full time

Job summary

Planet Pharma in Los Angeles, CA is seeking an experienced Product Development & Engineering professional to lead end-to-end product development activities from design through validation for medical devices.

The role requires 5-7 years in Quality Assurance/Quality Systems, ISO 13485 knowledge, and experience with GDP/GDPMDS regulatory pathways; strong cross-functional collaboration with R&D, manufacturing, and regulatory teams is essential.

Qualifications

• BS in Mechanical, Electrical, Biomedical, or related Engineering field.
• Bachelor’s degree or higher in Life Sciences or related discipline.
• Minimum 5-7 years of experience in Quality Assurance and/or Quality Systems within the medical device industry.
• Experience implementing or improving ISO 13485-based QMS.
• Strong experience working with Singapore medical device regulatory requirements.
• Demonstrated experience supporting or leading GDP/GDP certification projects.
• Experience interacting with certification bodies, accreditation bodies, and regulatory authorities.

Responsibilities

• Lead end-to-end product development activities including design, prototyping, testing, and validation.
• Drive technical decisions and provide engineering expertise throughout the product lifecycle.
• Develop and review engineering specifications, design documents, and technical reports.
• Identify and resolve complex engineering challenges using systematic problem-solving approaches.
• Partner with R&D, Quality, Manufacturing, Marketing, and Regulatory teams to ensure alignment.
• Serve as a technical resource and mentor for junior engineers.
• Communicate technical concepts clearly to both technical and non-technical stakeholders.
• Lead or contribute to multiple concurrent engineering projects.
• Define project scope, timelines, and deliverables; track milestones and manage risks.
• Ensure products meet regulatory requirements (ISO, FDA, MDR) and internal quality standards.
• Support design verification and validation activities; participate in design reviews, FMEAs, risk assessments, change control.
• Identify opportunities to improve products, processes, and engineering practices using data-driven methods.

Skills

Product engineering

V&V testing

Design controls

Regulatory knowledge

Cross-functional collaboration

Education

B.S. in Mechanical, Electrical, Biomedical, or related Engineering field

Bachelor’s degree or higher in Life Sciences or related discipline

Job description

Pay 50-53/h depending on experience

Product Development & Engineering

• Lead end-to-end product development activities including design, prototyping, testing, and validation
• Drive technical decisions and provide engineering expertise throughout the product lifecycle
• Develop and review engineering specifications, design documents, and technical reports
• Identify and resolve complex engineering challenges using systematic problem-solving approaches
• Cross-Functional Collaboration
• Partner with R&D, Quality, Manufacturing, Marketing, and Regulatory teams to ensure alignment
• Serve as a technical resource and mentor for junior engineers
• Communicate technical concepts clearly to both technical and non-technical stakeholders
• Project Leadership
• Lead or contribute to multiple concurrent engineering projects
• Define project scope, timelines, and deliverables
• Track milestones and proactively manage risks and dependencies Quality & Compliance
• Ensure products meet regulatory requirements (e.g., ISO, FDA, MDR) and internal quality standards
• Support design verification and validation (V&V) activities
• Participate in design reviews, FMEAs, risk assessments, and change control processes
• Continuous Improvement
• Identify opportunities to improve products, processes, and engineering practices
• Apply data-driven methods to analyze performance and drive decisions
• Stay current with industry trends, emerging technologies, and best practices

Requirements:

• B.S. in Mechanical, Electrical, Biomedical, or related Engineering field
• * Bachelor’s degree or higher in Life Sciences or related discipline
• * Minimum 5-7 years of experience in Quality Assurance and/or Quality Systems within the medical device industry.
• * Experience implementing or improving ISO 13485-based QMS.
• * Strong experience working with Singapore medical device regulatory requirements.
• * Demonstrated experience supporting or leading GDPMDS/GDP certification projects.
• * Proven track record of successfully helping organizations obtain and maintain GDP certification
• * Experience interacting with certification bodies, accreditation bodies, and regulatory authorities.

Technical skills:

• 5-8+ years of product engineering experience
• Validation experience, design analysis, V&V testing, PLM, Design Controls, ISO 13485, FDA 21 CFR Part 820