Senior R&D Engineer

Job Title: Senior R&D EngineerJob Description

A growing medical device manufacturer is seeking a Senior R&D Engineer to lead product development initiatives from concept through commercialization. This individual will serve as a key technical contributor within a highly collaborative and entrepreneurial environment, partnering closely with leadership, manufacturing, quality, regulatory affairs, suppliers, and external engineering partners. Unlike larger organizations with highly specialized roles, this position requires a hands-on engineer who can contribute across multiple functions including product design, prototyping, testing, regulatory documentation, manufacturing support, supplier management, and sustaining engineering activities. The ideal candidate possesses strong medical device product development experience and can independently drive projects while balancing technical, quality, regulatory, and business objectives.

Responsibilities

• Lead new product development and existing product improvement initiatives.

• Develop product concepts, design requirements, specifications, and engineering documentation.

• Create and maintain design history file (DHF) documentation throughout the development lifecycle.

• Execute design control activities in compliance with FDA and ISO requirements.

• Design, prototype, test, and validate new products and design modifications.

• Coordinate verification and validation activities.

• Conduct root cause investigations and implement corrective actions for product and process issues.

• Partner with manufacturing teams to support product launches and design transfer activities.

• Collaborate with quality and regulatory teams to ensure compliance with applicable standards and regulations.

• Evaluate materials, components, suppliers, and manufacturing methods.

• Manage external engineering resources, testing labs, consultants, and suppliers as needed.

• Perform risk management activities including FMEA development and maintenance.

• Support sustaining engineering projects focused on reliability improvements, cost reduction, manufacturability, and product performance enhancements.

• Assist with technical documentation required for regulatory submissions and product changes.

• Stay current on emerging technologies, materials, and industry best practices.

Essential Skills

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Electrical Engineering, or related engineering discipline.

• 5+ years of medical device product development experience.

• Experience working within FDA-regulated environments with a strong understanding of design controls and product development processes.

• Experience supporting design verification and validation activities.

• Proficiency with CAD software and 3D modeling tools.

• Experience creating engineering drawings and technical specifications.

• Strong analytical, troubleshooting, and problem-solving skills.

• Ability to manage multiple projects and priorities simultaneously.

• Excellent communication and cross-functional collaboration skills.

Additional Skills & Qualifications

• Experience with Class I, II, or III medical devices.

• Experience with electromechanical medical devices.

• Experience with risk management methodologies including FMEA.

• Knowledge of human factors and usability engineering.

• Experience supporting manufacturing scale-up and design transfer.

• Experience working in a small or fast-growing medical device company.

• PMP or formal project management experience preferred.

Work Environment

This role is based onsite in an engineering lab where all production and administrative functions are also located. The work environment is dynamic and supports a small, family-owned company that is experiencing growth in their market.

Job Type & Location

This is a Permanent position based out of Simi Valley, CA.

Pay and Benefits

The pay range for this position is $150000.00 - $185000.00/yr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Medical, denta,l vison, PTO

Workplace Type

This is a fully onsite position in Simi Valley,CA.

Application Deadline

This position is anticipated to close on Oct 16, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email [email protected] for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.