Medical Device Engineer
Job in
San Diego, San Diego County, California, 92108, USA
Listed on 2026-07-27
Listing for:
Actalent
Full Time
position Listed on 2026-07-27
Job specializations:
-
Engineering
Biomedical Engineer, Materials Engineering, Quality Engineering, Process Engineer
Job Description & How to Apply Below
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.
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…
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