Medical Device Engineer 3

Job Description

Job Description

Job Title: Medical Device Engineer 3 Job Description

The Senior Medical Device Engineer will develop and optimize polymer-based membrane coatings for advanced biosensor products, combining hands-on laboratory work with detailed technical documentation to support product design, process development, qualification, validation, and commercialization in a regulated medical device environment.

Responsibilities

• Develop and optimize polymer-based membrane coatings and related material formulations for advanced biosensor products.
• Plan and perform hands-on wet-lab experiments involving polymers, coatings, chemistry, and materials development.
• Analyze experimental data, interpret results, and make sound engineering decisions to guide product and process development.
• Support design controls by contributing to design inputs, verification, validation, and design transfer activities.
• Participate in risk management activities, including identification, analysis, and mitigation of product and process risks.
• Support qualification and validation activities, including IQ/OQ/PQ, for materials, processes, and equipment.
• Generate high-quality technical documentation, including protocols, reports, standard operating procedures (SOPs), work instructions, and design control deliverables.
• Apply statistical and experimental design tools such as DOE and JMP to plan experiments and evaluate results.
• Collaborate closely with cross-functional teams including R&D, Quality, Manufacturing, Regulatory Affairs, and Process Development to advance products through the development pipeline.
• Ensure work complies with FDA, ISO, GxP, and other relevant regulatory and quality requirements.
• Contribute to continuous improvement of materials, processes, and documentation to enhance product performance and reliability.
• Communicate findings, project status, and technical recommendations clearly to scientists, engineers, and leadership stakeholders.

Essential Skills

• 5+ years of experience in medical device, biotech, semiconductor, pharmaceutical, or other regulated industries.
• Hands-on experience developing polymer-based materials, coatings, formulations, or related chemical systems in a regulated environment.
• Strong laboratory skills in wet chemistry, material development, and formulation optimization.
• Experience designing products or components within regulated environments.
• Experience supporting design controls and risk management activities.
• Experience with qualification and validation activities, including IQ/OQ/PQ.
• Comfort generating technical documentation such as protocols, reports, SOPs, work instructions, and design control deliverables.
• Experience working within FDA, ISO, or GxP environments.
• Ability to interpret experimental data and make informed engineering decisions.
• Strong technical writing and documentation skills.
• Strong communication and presentation skills.
• Ability to work effectively in a cross-functional team environment.

Additional Skills & Qualifications

• Bachelor's degree in Materials Science, Polymer Science, Chemical Engineering, Chemistry, Biomedical Engineering, or a related field.
• Experience with design of experiments (DOE) and statistical analysis tools such as JMP.
• Experience with materials, polymers, chemistry, coatings, enzymes, or related technologies.
• Familiarity with product development processes in medical device or similar regulated industries.
• Interest in advanced biosensor technology and next-generation materials science.
• Desire to work in a highly innovative R&D environment and collaborate with Senior scientists, engineers, and technical leaders.
• Motivation to support products as they move through the development pipeline toward commercialization.

Work Environment

This role is based in an onsite R&D laboratory environment focused on biosensor product development in San Diego, CA. The position typically splits time approximately 50% on laboratory experimentation and 50% on technical documentation. Daily work involves hands-on wet chemistry, materials science, and polymer formulation development using laboratory equipment and tools appropriate for a highly regulated medical device setting. The engineer collaborates closely with scientists, engineers, quality, manufacturing, regulatory, and process development teams in a cross-functional, team-oriented culture. The environment operates under FDA, ISO, and GxP requirements, with a strong emphasis on quality, documentation, and compliance. Standard business hours are Monday through Friday, approximately 8:00 AM to 5:00 PM, in a professional laboratory and office setting.

Job Type & Location

This is a Contract position based out of San Diego, CA.

Pay and Benefits

The pay range for this position is $56.00 - $68.00/hr.

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.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in San Diego,CA.

Application Deadline

This position is anticipated to close on Aug 28, 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 withoutregard to race, sex, age, color, religion, national origin, veteran status, disability,sexual orientation, gender identity, genetic information or any characteristic protectedby law.

If you would like to request a reasonable accommodation, such as the modification oradjustment of the job application process or interviewing process due to a disability,please email View email address on us.fitly.work for other accommodation options.

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

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as acondition of employment or continued employment. An employer who violates this lawshall 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 applicationsand qualifications, but final decisions are made by our hiring team. By applying, youacknowledge and agree that your application may be reviewed using AI tools.