Sr Product Engineer

Lancesoft; Los Angeles (CA); On-site; USD 120,000 - 160,000; Full time

Job summary

LanceSoft seeks an experienced Product Development & Engineering Lead in Northridge, CA to steer end-to-end product development for medical devices, including design, prototyping, testing, and validation.

You will drive technical decisions, author engineering specs, collaborate with R&D, Quality, Manufacturing, and Regulatory teams, and mentor junior engineers while ensuring compliance with ISO 13485 and FDA requirements.

Qualifications

• Bachelor’s degree in Mechanical, Electrical, Biomedical, or related Engineering field or higher in Life Sciences or related discipline.
• 5-7 years of experience in Quality Assurance/Quality Systems in medical devices.
• Experience implementing or improving ISO 13485-based QMS.
• Strong knowledge of Singapore medical device regulatory requirements.
• Experience supporting GDPMDS/GDP certification projects.

Responsibilities

• Lead end-to-end product development activities including design, prototyping, testing and validation.
• Drive technical decisions and provide engineering expertise through the product lifecycle.
• Develop and review engineering specifications, design documents and technical reports.
• Identify and resolve complex engineering challenges using systematic problem solving.

Skills

V&V testing

Design Controls

PLM

ISO 13485

Regulatory knowledge

Education

Bachelor's degree in Mechanical, Electrical, Biomedical, or related Engineering

Job description

Join our dynamic team in Northridge, CA, where innovation meets excellence. We are seeking an experienced professional to lead and drive product engineering initiatives in the medical device industry.

Qualifications

• 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
• Experience 5-8 years of product engineering experience

Technical Skills

Validation experience, design analysis, V&V testing, PLM, Design Controls, ISO 13485, FDA 21 CFR Part 820

Role Summary

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

EEO Employer

LanceSoft is a certified Minority Business Enterprise (MBE) and an equal opportunity employer. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. LanceSoft makes hiring decisions based solely on qualifications, merit, and business needs at the time.